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    Clinical Trial Results:
    A Phase II, Randomized, Placebo-Controlled, Double-Blind Study of the Safety and Efficacy of MPSK3169A in Patients with Coronary Heart Disease or High Risk of Coronary Heart Disease

    Summary
    EudraCT number
    2012-000191-41
    Trial protocol
    HU   DE   CZ   SK  
    Global end of trial date
    22 Jul 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Mar 2016
    First version publication date
    04 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GC28210
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01609140
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, CH-4070, Basel, Switzerland,
    Public contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Sep 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jul 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and efficacy of MPSK3169A on top of standard-of-care (SOC) statin in participants with a low-density lipoprotein cholesterol (LDLc) of 90−250 milligrams per deciliter (mg/dL) and either coronary heart disease (CHD) or a CHD risk equivalent.
    Protection of trial subjects
    Efforts to minimize risk included the following: judicious eligibility of participants who may benefit from LDLc lowering because of a combination of high cardiovascular risk and LDLc levels well above the goal of 70 mg/dL, use of SOC statin therapy for all participants, regular safety evaluations overseen by the investigator, study overseen by an internal monitoring committee (IMC), and the use of a minimum threshold of LDLc below which MPSK3169A would be withheld. This study was conducted in full conformance with the International Conference on Harmonisation (ICH) E6 guideline for Good Clinical Practice (GCP) and the principles of the Declaration of Helsinki or the laws and regulations of the country in which the research was conducted, whichever afforded the greater protection to the individual.
    Background therapy
    All participants regardless of treatment assignment received SOC treatment with statins. The type and dose of statin therapy was not changed during the run-in, treatment, or follow-up periods of the study.
    Evidence for comparator
    -
    Actual start date of recruitment
    21 May 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Norway: 21
    Country: Number of subjects enrolled
    Slovakia: 10
    Country: Number of subjects enrolled
    Czech Republic: 9
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Hungary: 13
    Country: Number of subjects enrolled
    Canada: 44
    Country: Number of subjects enrolled
    New Zealand: 9
    Country: Number of subjects enrolled
    South Africa: 4
    Country: Number of subjects enrolled
    United States: 137
    Worldwide total number of subjects
    248
    EEA total number of subjects
    54
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    125
    From 65 to 84 years
    123
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Participants who met all of the eligibility criteria except the inclusion criterion pertaining to statins and other lipid-modifying therapies entered run-in period of 6 weeks until they were on stable SOC statin therapy for at least 4 weeks, and were off prohibited lipid-modifying therapies for at least 4 weeks (or 6 weeks in the case of fibrates).

    Period 1
    Period 1 title
    Treatment Period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    MPSK3169A 400 mg once every 4 weeks (Q4W)
    Arm description
    Participants received 400 mg of MPSK3169A Q4W subcutaneously for approximately 24 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    MPSK3169A
    Investigational medicinal product code
    RO6801831
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    All participants in the study received subcutaneous doses of MPSK3169A or matching placebo every four weeks.

    Arm title
    MPSK3169A 200 mg Q8W
    Arm description
    Participants received 200 mg of MPSK3169A Q8W subcutaneously for approximately 24 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    MPSK3169A
    Investigational medicinal product code
    RO6801831
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    All participants in the study received subcutaneous doses of MPSK3169A or matching placebo every four weeks.

    Arm title
    MPSK3169A 400 mg Q8W
    Arm description
    Participants received 400 mg of MPSK3169A Q8W subcutaneously for approximately 24 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    MPSK3169A
    Investigational medicinal product code
    RO6801831
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    All participants in the study received subcutaneous doses of MPSK3169A or matching placebo every four weeks.

    Arm title
    MPSK3169A 800 mg Q8W
    Arm description
    Participants received 800 mg of MPSK3169A Q8W subcutaneously for approximately 24 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    MPSK3169A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    All participants in the study received subcutaneous doses of MPSK3169A or matching placebo every four weeks.

    Arm title
    MPSK3169A 800 mg Q12W
    Arm description
    Participants received 800 mg of MPSK3169A Q12W subcutaneously for approximately 24 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    MPSK3169A
    Investigational medicinal product code
    RO6801831
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    All participants in the study received subcutaneous doses of MPSK3169A or matching placebo every four weeks.

    Arm title
    Placebo
    Arm description
    Participants received matching placebo injections subcutaneously for approximately 24 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    All participants in the study received subcutaneous doses of matching placebo every four weeks.

    Number of subjects in period 1
    MPSK3169A 400 mg once every 4 weeks (Q4W) MPSK3169A 200 mg Q8W MPSK3169A 400 mg Q8W MPSK3169A 800 mg Q8W MPSK3169A 800 mg Q12W Placebo
    Started
    57
    23
    30
    51
    23
    64
    Completed
    52
    23
    28
    46
    23
    57
    Not completed
    5
    0
    2
    5
    0
    7
         Consent withdrawn by subject
    1
    -
    1
    2
    -
    3
         Death
    -
    -
    -
    -
    -
    1
         Randomized on calculated LDL only, not Direct
    -
    -
    -
    1
    -
    -
         Adverse event
    1
    -
    -
    -
    -
    1
         Participant moved out of state
    1
    -
    -
    -
    -
    -
         Lost to follow-up
    -
    -
    1
    -
    -
    -
         Participant stopped study drug
    1
    -
    -
    -
    -
    -
         Physician/Subject Unblinding
    -
    -
    -
    -
    -
    1
         Protocol deviation
    1
    -
    -
    2
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MPSK3169A 400 mg once every 4 weeks (Q4W)
    Reporting group description
    Participants received 400 mg of MPSK3169A Q4W subcutaneously for approximately 24 weeks.

    Reporting group title
    MPSK3169A 200 mg Q8W
    Reporting group description
    Participants received 200 mg of MPSK3169A Q8W subcutaneously for approximately 24 weeks.

    Reporting group title
    MPSK3169A 400 mg Q8W
    Reporting group description
    Participants received 400 mg of MPSK3169A Q8W subcutaneously for approximately 24 weeks.

    Reporting group title
    MPSK3169A 800 mg Q8W
    Reporting group description
    Participants received 800 mg of MPSK3169A Q8W subcutaneously for approximately 24 weeks.

    Reporting group title
    MPSK3169A 800 mg Q12W
    Reporting group description
    Participants received 800 mg of MPSK3169A Q12W subcutaneously for approximately 24 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Participants received matching placebo injections subcutaneously for approximately 24 weeks.

    Reporting group values
    MPSK3169A 400 mg once every 4 weeks (Q4W) MPSK3169A 200 mg Q8W MPSK3169A 400 mg Q8W MPSK3169A 800 mg Q8W MPSK3169A 800 mg Q12W Placebo Total
    Number of subjects
    57 23 30 51 23 64 248
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    65.6 ± 8.5 63.3 ± 10 62.8 ± 8.1 63.9 ± 8.9 63.8 ± 7.2 63.1 ± 7.8 -
    Gender categorical
    Units: Subjects
        Female
    24 8 16 25 10 24 107
        Male
    33 15 14 26 13 40 141

    End points

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    End points reporting groups
    Reporting group title
    MPSK3169A 400 mg once every 4 weeks (Q4W)
    Reporting group description
    Participants received 400 mg of MPSK3169A Q4W subcutaneously for approximately 24 weeks.

    Reporting group title
    MPSK3169A 200 mg Q8W
    Reporting group description
    Participants received 200 mg of MPSK3169A Q8W subcutaneously for approximately 24 weeks.

    Reporting group title
    MPSK3169A 400 mg Q8W
    Reporting group description
    Participants received 400 mg of MPSK3169A Q8W subcutaneously for approximately 24 weeks.

    Reporting group title
    MPSK3169A 800 mg Q8W
    Reporting group description
    Participants received 800 mg of MPSK3169A Q8W subcutaneously for approximately 24 weeks.

    Reporting group title
    MPSK3169A 800 mg Q12W
    Reporting group description
    Participants received 800 mg of MPSK3169A Q12W subcutaneously for approximately 24 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Participants received matching placebo injections subcutaneously for approximately 24 weeks.

    Primary: Absolute Change From Baseline in LDLc Concentration at Day 169

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    End point title
    Absolute Change From Baseline in LDLc Concentration at Day 169
    End point description
    Modified Intent to Treat (mITT) population included participants who were randomized and received at least 1 dose of study drug. Participants with baseline measurement and post baseline measurement of LDLc concentration at Day 169 were included in the analysis of this end point.
    End point type
    Primary
    End point timeframe
    Baseline, Day 169
    End point values
    MPSK3169A 400 mg once every 4 weeks (Q4W) MPSK3169A 200 mg Q8W MPSK3169A 400 mg Q8W MPSK3169A 800 mg Q8W MPSK3169A 800 mg Q12W Placebo
    Number of subjects analysed
    45 [1]
    21 [2]
    28 [3]
    44 [4]
    19 [5]
    59 [6]
    Units: milligram(s)/deciliter
        arithmetic mean (standard deviation)
    -72.7 ± 24.6
    -13.6 ± 26.1
    -33.4 ± 32.5
    -55.8 ± 29.9
    -23.9 ± 25.7
    -10.6 ± 24.8
    Notes
    [1] - Includes participants who were evaluable with non-missing LDLc values at baseline and Day 169.
    [2] - Includes participants who were evaluable with non-missing LDLc values at baseline and Day 169.
    [3] - Includes participants who were evaluable with non-missing LDLc values at baseline and Day 169.
    [4] - Includes participants who were evaluable with non-missing LDLc values at baseline and Day 169.
    [5] - Includes participants who were evaluable with non-missing LDLc values at baseline and Day 169.
    [6] - Includes participants who were evaluable with non-missing LDLc values at baseline and Day 169.
    Statistical analysis title
    Statistical analysis I
    Statistical analysis description
    This analysis was performed on Day 169. Least squares (LS) mean difference, 95% confidence intervals (CIs) and p−values were based on an analysis of covariance model adjusted for baseline LDLc (less than [<] 120 mg/dL, greater than or equal to [≥] 120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=104.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    61.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    51.7
         upper limit
    71.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.1
    Statistical analysis title
    Statistical analysis II
    Statistical analysis description
    This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7885
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    1.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11.1
         upper limit
    14.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.5
    Statistical analysis title
    Statistical analysis III
    Statistical analysis description
    This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=87.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0005
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    21
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    9.3
         upper limit
    32.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.9
    Statistical analysis title
    Statistical analysis IV
    Statistical analysis description
    This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    43.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    33.3
         upper limit
    53.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.2
    Statistical analysis title
    Statistical analysis V
    Statistical analysis description
    Differences from Pbo are the difference between LS means with the standard error. P−values are adjusted for baseline LDLc (<120 mg/dL, >=120 mg/dL) and diabetes status (yes,no) and not adjusted for multiple testing. Number of subjects included in analysis=78.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0579
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    12.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.4
         upper limit
    26.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.8

    Secondary: Absolute Change From Baseline in LDLc Concentration for Each Arm at the Nadir for That Arm

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    End point title
    Absolute Change From Baseline in LDLc Concentration for Each Arm at the Nadir for That Arm
    End point description
    Nadir is defined as the planned visit, up to day 169, with the greatest mean decrease within a treatment group. mITT population participants with baseline measurement and at least 1 postbaseline measurement of LDLc concentration were included in the analysis of this end point.
    End point type
    Secondary
    End point timeframe
    Baseline, up to Day 169 (Nadir)
    End point values
    MPSK3169A 400 mg once every 4 weeks (Q4W) MPSK3169A 200 mg Q8W MPSK3169A 400 mg Q8W MPSK3169A 800 mg Q8W MPSK3169A 800 mg Q12W Placebo
    Number of subjects analysed
    50 [7]
    20 [8]
    27 [9]
    46 [10]
    22 [11]
    61 [12]
    Units: milligram(s)/deciliter
        arithmetic mean (standard deviation)
    -84.8 ± 29.9
    -70.6 ± 18.1
    -82.9 ± 28.4
    -86 ± 26
    -87.6 ± 32.1
    -11.4 ± 19.8
    Notes
    [7] - Includes participants who were evaluable with non-missing LDLc values at baseline and up to Day 169.
    [8] - Includes participants who were evaluable with non-missing LDLc values at baseline and up to Day 169.
    [9] - Includes participants who were evaluable with non-missing LDLc values at baseline and up to Day 169.
    [10] - Includes participants who were evaluable with non-missing LDLc values at baseline and up to Day 169.
    [11] - Includes participants who were evaluable with non-missing LDLc values at baseline and up to Day 169.
    [12] - Includes participants who were evaluable with non-missing LDLc values at baseline and up to Day 169.
    Statistical analysis title
    Statistical analysis I
    Statistical analysis description
    This analysis was performed at nadir timepoint. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=111.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    72.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    64
         upper limit
    81.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.4
    Statistical analysis title
    Statistical analysis II
    Statistical analysis description
    This analysis was performed at nadir timepoint. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    55.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    44.4
         upper limit
    67.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.8
    Statistical analysis title
    Statistical analysis III
    Statistical analysis description
    This analysis was performed at nadir timepoint. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=88.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    67.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    57.1
         upper limit
    77.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.3
    Statistical analysis title
    Statistical analysis IV
    Statistical analysis description
    This analysis was performed at nadir timepoint. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    70.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    61.8
         upper limit
    79.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.5
    Statistical analysis title
    Statistical analysis V
    Statistical analysis description
    This analysis was performed at nadir timepoint. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    73.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    62.8
         upper limit
    85
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.6

    Secondary: Average Change from Baseline in LDLc Concentration Weighted By the Number of Weeks Between Consecutive LDLc Measurements at Day 169

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    End point title
    Average Change from Baseline in LDLc Concentration Weighted By the Number of Weeks Between Consecutive LDLc Measurements at Day 169
    End point description
    This outcome was calculated by dividing the average change from baseline of LDLc concentration by average number of weeks of study treatment. mITTpopulation participants with baseline and post baseline measurement of LDLc concentration at Day 169 were included in the analysis of this end point.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 169
    End point values
    MPSK3169A 400 mg once every 4 weeks (Q4W) MPSK3169A 200 mg Q8W MPSK3169A 400 mg Q8W MPSK3169A 800 mg Q8W MPSK3169A 800 mg Q12W Placebo
    Number of subjects analysed
    44 [13]
    21 [14]
    28 [15]
    43 [16]
    19 [17]
    59 [18]
    Units: mg/dL/week
        arithmetic mean (standard deviation)
    -79.3 ± 25
    -36.7 ± 17.4
    -60.9 ± 22.3
    -74.5 ± 21
    -61.9 ± 18.2
    -9.6 ± 19.1
    Notes
    [13] - Includes participants who were evaluable with non-missing LDLc values at baseline and Day 169.
    [14] - Includes participants who were evaluable with non-missing LDLc values at baseline and Day 169.
    [15] - Includes participants who were evaluable with non-missing LDLc values at baseline and Day 169.
    [16] - Includes participants who were evaluable with non-missing LDLc values at baseline and Day 169.
    [17] - Includes participants who were evaluable with non-missing LDLc values at baseline and Day 169.
    [18] - Includes participants who were evaluable with non-missing LDLc values at baseline and Day 169.
    Statistical analysis title
    Statistical analysis I
    Statistical analysis description
    This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    68.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    61.1
         upper limit
    76
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.8
    Statistical analysis title
    Statistical analysis II
    Statistical analysis description
    This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    25.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    16
         upper limit
    34.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.8
    Statistical analysis title
    Statistical analysis III
    Statistical analysis description
    This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=87.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    48.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    40.2
         upper limit
    57.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.4
    Statistical analysis title
    Statistical analysis IV
    Statistical analysis description
    This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=102.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    62.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    54.7
         upper limit
    69.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.8
    Statistical analysis title
    Statistical analysis V
    Statistical analysis description
    This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=78.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    51.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    41.9
         upper limit
    61.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    5

    Secondary: Average Percentage Change from Baseline in LDLc Concentration Weighted By the Number of Weeks Between Consecutive LDLc Measurements at Day 169

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    End point title
    Average Percentage Change from Baseline in LDLc Concentration Weighted By the Number of Weeks Between Consecutive LDLc Measurements at Day 169
    End point description
    mITT population participants with baseline and post baseline measurement of LDLc concentration at Day 169 were included in the analysis of this end point.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 169
    End point values
    MPSK3169A 400 mg once every 4 weeks (Q4W) MPSK3169A 200 mg Q8W MPSK3169A 400 mg Q8W MPSK3169A 800 mg Q8W MPSK3169A 800 mg Q12W Placebo
    Number of subjects analysed
    44 [19]
    21 [20]
    28 [21]
    43 [22]
    19 [23]
    59 [24]
    Units: percentage change/week
        arithmetic mean (standard deviation)
    -63.9 ± 14.2
    -29.3 ± 12.6
    -46 ± 10.5
    -59.6 ± 14.5
    -48.8 ± 9.5
    -7.1 ± 15.5
    Notes
    [19] - Includes participants who were evaluable with non-missing LDLc values at baseline and Day 169.
    [20] - Includes participants who were evaluable with non-missing LDLc values at baseline and Day 169.
    [21] - Includes participants who were evaluable with non-missing LDLc values at baseline and Day 169.
    [22] - Includes participants who were evaluable with non-missing LDLc values at baseline and Day 169.
    [23] - Includes participants who were evaluable with non-missing LDLc values at baseline and Day 169.
    [24] - Includes participants who were evaluable with non-missing LDLc values at baseline and Day 169.
    Statistical analysis title
    Statistical analysis I
    Statistical analysis description
    This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    56.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    51.1
         upper limit
    62
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.8
    Statistical analysis title
    Statistical analysis II
    Statistical analysis description
    This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    22
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    15.1
         upper limit
    28.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.5
    Statistical analysis title
    Statistical analysis III
    Statistical analysis description
    This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=87.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    38.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    32.2
         upper limit
    44.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.2
    Statistical analysis title
    Statistical analysis IV
    Statistical analysis description
    This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=102.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    52.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    46.6
         upper limit
    57.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.8
    Statistical analysis title
    Statistical analysis V
    Statistical analysis description
    This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=78.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    41.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    34.4
         upper limit
    48.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.6

    Secondary: Percentage Change from Baseline in LDLc Concentration for Each Arm at Day 169 and at the Nadir for That Arm

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    End point title
    Percentage Change from Baseline in LDLc Concentration for Each Arm at Day 169 and at the Nadir for That Arm
    End point description
    Nadir is defined as the planned visit, up to day 169, with the greatest mean decrease within a treatment group. mITT population participants with baseline and post baseline measurement of LDLc concentration at Day 169 were included in the analysis of this end point. "n" value indicates the number of participants evaluable at a specified timepoint for a particular treatment arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 169, up to Day 169 (Nadir)
    End point values
    MPSK3169A 400 mg once every 4 weeks (Q4W) MPSK3169A 200 mg Q8W MPSK3169A 400 mg Q8W MPSK3169A 800 mg Q8W MPSK3169A 800 mg Q12W Placebo
    Number of subjects analysed
    50 [25]
    21 [26]
    28 [27]
    46 [28]
    22 [29]
    61 [30]
    Units: percentage change
    arithmetic mean (standard deviation)
        % change from baseline in LDL-c at Day 169
    -58.7 ± 14.9
    -10.5 ± 18.1
    -23.3 ± 20.5
    -44.3 ± 21.1
    -16.1 ± 19.4
    -7.7 ± 20.3
        % change from baseline in LDL-c at nadir
    -69.6 ± 17.3
    -57.7 ± 15.6
    -64.4 ± 15
    -68.7 ± 17.1
    -66.1 ± 14.9
    -9 ± 16.4
    Notes
    [25] - n=45 on Day 169 and n=50 at nadir.
    [26] - n=21 on Day 169 and n=20 at nadir.
    [27] - n=28 on Day 169 and n=27 at nadir.
    [28] - n=44 on Day 169 and n=46 at nadir.
    [29] - n=19 on Day 169 and n=22 at nadir.
    [30] - n=59 on Day 169 and n=61 at nadir.
    Statistical analysis title
    Statistical analysis I
    Statistical analysis description
    This analysis was performed on Day 169. LS mean difference, 95% CIs and p-values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=104.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    51
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    43.5
         upper limit
    58.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.8
    Statistical analysis title
    Statistical analysis II
    Statistical analysis description
    This analysis was performed on Day 169. LS mean difference, 95% CIs and p-values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6097
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    2.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.1
         upper limit
    12.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.9
    Statistical analysis title
    Statistical analysis III
    Statistical analysis description
    This analysis was performed on Day 169. LS mean difference, 95% CIs and p-values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=87.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0007
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    15.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.4
         upper limit
    23.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.4
    Statistical analysis title
    Statistical analysis IV
    Statistical analysis description
    This analysis was performed on Day 169. LS mean difference, 95% CIs and p-values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    36.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    28.6
         upper limit
    43.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.8
    Statistical analysis title
    Statistical analysis V
    Statistical analysis description
    This analysis was performed on Day 169. LS mean difference, 95% CIs and p-values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=78.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1027
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    8.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.7
         upper limit
    18.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    5
    Statistical analysis title
    Statistical analysis VI
    Statistical analysis description
    This analysis was performed at Nadir timepoint. LS mean difference, 95% CIs and p-values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=111.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    59.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    53.5
         upper limit
    66
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.2
    Statistical analysis title
    Statistical analysis VII
    Statistical analysis description
    This analysis was performed at Nadir timepoint. LS mean difference, 95% CIs and p-values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.
    Comparison groups
    MPSK3169A 200 mg Q8W v Placebo
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    48.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    39.9
         upper limit
    56.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.2
    Statistical analysis title
    Statistical analysis VIII
    Statistical analysis description
    This analysis was performed at Nadir timepoint. LS mean difference, 95% CIs and p-values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=88.
    Comparison groups
    MPSK3169A 400 mg Q8W v Placebo
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    54.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    46.9
         upper limit
    61.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.8
    Statistical analysis title
    Statistical analysis IX
    Statistical analysis description
    This analysis was performed at Nadir timepoint. LS mean difference, 95% CIs and p-values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.
    Comparison groups
    MPSK3169A 800 mg Q8W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    58.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    52.4
         upper limit
    65.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.2
    Statistical analysis title
    Statistical analysis X
    Statistical analysis description
    This analysis was performed at Nadir timepoint. LS mean difference, 95% CIs and p-values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.
    Comparison groups
    MPSK3169A 800 mg Q12W v Placebo
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    56.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    48.5
         upper limit
    64.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.1

    Secondary: Absolute Change From Baseline (CFB) in LDLc Concentration at all Other TimePoints

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    End point title
    Absolute Change From Baseline (CFB) in LDLc Concentration at all Other TimePoints
    End point description
    mITT population participants with baseline and at least 1 post baseline measurement of LDLc concentration were included in the analysis of this end point. "n" value indicates the number of participants evaluable at a specified timepoint for a particular treatment arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 8, 15, 22, 29, 43, 57, 71, 85, 99, 113, 120, 141, and 155
    End point values
    MPSK3169A 400 mg once every 4 weeks (Q4W) MPSK3169A 200 mg Q8W MPSK3169A 400 mg Q8W MPSK3169A 800 mg Q8W MPSK3169A 800 mg Q12W Placebo
    Number of subjects analysed
    53
    23
    28
    49
    23
    63
    Units: mg/dL
    arithmetic mean (standard deviation)
        Day 8 (n=50,23,25,43,22,60)
    -65.8 ± 18.4
    -61.6 ± 20.7
    -70 ± 25.1
    -68.6 ± 24.2
    -67.6 ± 21.6
    -8.8 ± 17.9
        Day 15 (n=50,23,28,44,20,61)
    -78.1 ± 24.7
    -65.4 ± 24.3
    -79.8 ± 27.5
    -82.5 ± 21.9
    -80.6 ± 25
    -11.4 ± 19.8
        Day 22 (n=47,23,28,47,23,61)
    -81 ± 25
    -61.4 ± 21
    -83.1 ± 29.8
    -85 ± 22.3
    -83.8 ± 31.4
    -9 ± 21.5
        Day 29 (n=49,23,28,49,21,63)
    -74.6 ± 27.1
    -44.4 ± 22.5
    -76.1 ± 28.4
    -82.8 ± 25.8
    -85.4 ± 33.3
    -7.6 ± 22.8
        Day 43 (n=50,22,26,46,23,61)
    -84.8 ± 29.9
    -24.7 ± 18.5
    -65 ± 30.6
    -74.2 ± 25.1
    -75.6 ± 35
    -7.8 ± 22.1
        Day 57 (n=53,23,28,48,22,58)
    -76.3 ± 30.9
    -13.3 ± 25.3
    -34.9 ± 30.2
    -59 ± 23.5
    -68.6 ± 24.7
    -6.1 ± 24.8
        Day 71 (n=53,20,27,46,22,59)
    -84.2 ± 29.4
    -70.6 ± 18.1
    -82.9 ± 28.4
    -86 ± 26
    -40.1 ± 27.8
    -9.1 ± 22.1
        Day 85 (n=53,23,28,47,22,61)
    -74.7 ± 35.2
    -50.7 ± 21.1
    -73.8 ± 28.3
    -81.4 ± 24.7
    -24.8 ± 25.4
    -11.9 ± 26.5
        Day 99 (n=50,23,28,44,20,57)
    -81 ± 29.6
    -20.8 ± 25
    -57.9 ± 23.5
    -71.8 ± 25.4
    -86.5 ± 28
    -7.9 ± 23.5
        Day 113 (n=48,23,27,45,22,58)
    -75.3 ± 28.9
    -14.3 ± 25.7
    -36.5 ± 32.2
    -55.6 ± 29.4
    -87.6 ± 32.1
    -9.8 ± 22.1
        Day 120 (n=47,23,27,44,22,58)
    -81.6 ± 26.4
    -59.6 ± 20.3
    -72.2 ± 28.6
    -80.6 ± 24.7
    -85.1 ± 31.6
    -8 ± 24.4
        Day 141 (n=48,22,27,46,21,57)
    -72.4 ± 31.4
    -45.4 ± 23.3
    -74.2 ± 21.8
    -81.4 ± 26.5
    -67.9 ± 27.2
    -10.4 ± 24.4
        Day 155 (n=47,22,28,42,22,58)
    -79.1 ± 29.9
    -21.6 ± 23.6
    -55.7 ± 25.2
    -75.7 ± 23.5
    -43.8 ± 28.6
    -12.9 ± 22.2
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    This analysis was performed on Day 8. LS mean difference, 95% CIs and p-values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=110.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    54.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    46.8
         upper limit
    61.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.8
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    This analysis was performed on Day 8. LS mean difference, 95% CIs and p-values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    51.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    42.1
         upper limit
    60.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.7
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    This analysis was performed on Day 8. LS mean difference, 95% CIs and p-values were based on an analysis of covariance model adjusted for baseline LDL-c (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    57.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    48.1
         upper limit
    66.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.6
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    This analysis was performed on Day 8. LS mean difference, 95% CIs and p-values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    56.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    48.6
         upper limit
    63.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.9
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    This analysis was performed on Day 8. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=82.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    56.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    46.7
         upper limit
    65.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.8
    Statistical analysis title
    Statistical analysis 6
    Statistical analysis description
    This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=111.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    65.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    57.4
         upper limit
    74.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.2
    Statistical analysis title
    Statistical analysis 7
    Statistical analysis description
    This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.
    Comparison groups
    MPSK3169A 200 mg Q8W v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    53
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    42.4
         upper limit
    63.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.3
    Statistical analysis title
    Statistical analysis 8
    Statistical analysis description
    This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.
    Comparison groups
    MPSK3169A 400 mg Q8W v Placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    64.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    55
         upper limit
    74.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    5
    Statistical analysis title
    Statistical analysis 9
    Statistical analysis description
    This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    69
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    60.4
         upper limit
    77.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.3
    Statistical analysis title
    Statistical analysis 10
    Statistical analysis description
    This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.
    Comparison groups
    MPSK3169A 800 mg Q12W v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    66.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    55.7
         upper limit
    77.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.6
    Statistical analysis title
    Statistical analysis 11
    Statistical analysis description
    This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=108.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    70.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    62.2
         upper limit
    79.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.4
    Statistical analysis title
    Statistical analysis 12
    Statistical analysis description
    This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.
    Comparison groups
    MPSK3169A 200 mg Q8W v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    51.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    40.5
         upper limit
    62.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.5
    Statistical analysis title
    Statistical analysis 13
    Statistical analysis description
    This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    71
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    60.9
         upper limit
    81.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.1
    Statistical analysis title
    Statistical analysis 14
    Statistical analysis description
    This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=108.
    Comparison groups
    MPSK3169A 800 mg Q8W v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    73.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    64.6
         upper limit
    81.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.4
    Statistical analysis title
    Statistical analysis 15
    Statistical analysis description
    This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.
    Comparison groups
    MPSK3169A 800 mg Q12W v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    72.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    61.8
         upper limit
    83.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.5
    Statistical analysis title
    Statistical analysis 16
    Statistical analysis description
    This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=112.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    67.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    58.1
         upper limit
    76.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.6
    Statistical analysis title
    Statistical analysis 17
    Statistical analysis description
    This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=86.
    Comparison groups
    MPSK3169A 200 mg Q8W v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    36.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    24.7
         upper limit
    47.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.8
    Statistical analysis title
    Statistical analysis 18
    Statistical analysis description
    This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=91.
    Comparison groups
    MPSK3169A 400 mg Q8W v Placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    66.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    55.3
         upper limit
    76.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.5
    Statistical analysis title
    Statistical analysis 19
    Statistical analysis description
    This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=112.
    Comparison groups
    MPSK3169A 800 mg Q8W v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    73.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    64.6
         upper limit
    82.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.6
    Statistical analysis title
    Statistical analysis 20
    Statistical analysis description
    This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.
    Comparison groups
    MPSK3169A 800 mg Q12W v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    76.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    64.5
         upper limit
    88.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.1
    Statistical analysis title
    Statistical analysis 21
    Statistical analysis description
    This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=111.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    78.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    68.8
         upper limit
    87.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.8
    Statistical analysis title
    Statistical analysis 22
    Statistical analysis description
    This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.
    Comparison groups
    MPSK3169A 200 mg Q8W v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0017
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    15.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.5
         upper limit
    27.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.1
    Statistical analysis title
    Statistical analysis 23
    Statistical analysis description
    This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=87.
    Comparison groups
    MPSK3169A 400 mg Q8W v Placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    53.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    41.7
         upper limit
    64.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.9
    Statistical analysis title
    Statistical analysis 24
    Statistical analysis description
    This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.
    Comparison groups
    MPSK3169A 800 mg Q8W v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    64.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    55.1
         upper limit
    74.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.9
    Statistical analysis title
    Statistical analysis 25
    Statistical analysis description
    This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.
    Comparison groups
    MPSK3169A 800 mg Q12W v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    66.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    54.4
         upper limit
    78.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.1
    Statistical analysis title
    Statistical analysis 26
    Statistical analysis description
    This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=111.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    71.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    62.1
         upper limit
    81.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.8
    Statistical analysis title
    Statistical analysis 27
    Statistical analysis description
    This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.
    Comparison groups
    MPSK3169A 200 mg Q8W v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2596
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.2
         upper limit
    19.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.2
    Statistical analysis title
    Statistical analysis 28
    Statistical analysis description
    This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=86.
    Comparison groups
    MPSK3169A 400 mg Q8W v Placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    27.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    16.3
         upper limit
    39.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.8
    Statistical analysis title
    Statistical analysis 29
    Statistical analysis description
    This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=106.
    Comparison groups
    MPSK3169A 800 mg Q8W v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    52.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    42.5
         upper limit
    62
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.9
    Statistical analysis title
    Statistical analysis 30
    Statistical analysis description
    This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.
    Comparison groups
    MPSK3169A 800 mg Q12W v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    61.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    49.2
         upper limit
    74.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.3
    Statistical analysis title
    Statistical analysis 31
    Statistical analysis description
    This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=112.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    74
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    65.1
         upper limit
    82.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.5
    Statistical analysis title
    Statistical analysis 32
    Statistical analysis description
    This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=79.
    Comparison groups
    MPSK3169A 200 mg Q8W v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    58.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    46.7
         upper limit
    70.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.1
    Statistical analysis title
    Statistical analysis 33
    Statistical analysis description
    This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=86.
    Comparison groups
    MPSK3169A 400 mg Q8W v Placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    70.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    59.7
         upper limit
    81.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.5
    Statistical analysis title
    Statistical analysis 34
    Statistical analysis description
    This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.
    Comparison groups
    MPSK3169A 800 mg Q8W v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    73.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    64.4
         upper limit
    82.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.7
    Statistical analysis title
    Statistical analysis 35
    Statistical analysis description
    This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.
    Comparison groups
    MPSK3169A 800 mg Q12W v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    29.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    17.5
         upper limit
    40.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.9
    Statistical analysis title
    Statistical analysis 36
    Statistical analysis description
    This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=114.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    62.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    52.8
         upper limit
    72
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.9
    Statistical analysis title
    Statistical analysis 37
    Statistical analysis description
    This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.
    Comparison groups
    MPSK3169A 200 mg Q8W v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    37.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    25.3
         upper limit
    50.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.3
    Statistical analysis title
    Statistical analysis 38
    Statistical analysis description
    This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.
    Comparison groups
    MPSK3169A 400 mg Q8W v Placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    58.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    47.1
         upper limit
    70.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.9
    Statistical analysis title
    Statistical analysis 39
    Statistical analysis description
    This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=108.
    Comparison groups
    MPSK3169A 800 mg Q8W v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    67.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    57.3
         upper limit
    77.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    5
    Statistical analysis title
    Statistical analysis 40
    Statistical analysis description
    This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.
    Comparison groups
    MPSK3169A 800 mg Q12W v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0795
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    11.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    23.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.4
    Statistical analysis title
    Statistical analysis 41
    Statistical analysis description
    This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    72.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    62.9
         upper limit
    81.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.7
    Statistical analysis title
    Statistical analysis 42
    Statistical analysis description
    This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.048
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    11.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.1
         upper limit
    23.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.9
    Statistical analysis title
    Statistical analysis 43
    Statistical analysis description
    This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    46.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    35.7
         upper limit
    57.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.9
    Statistical analysis title
    Statistical analysis 44
    Statistical analysis description
    This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=101.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    60.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    50.7
         upper limit
    69.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.9
    Statistical analysis title
    Statistical analysis 45
    Statistical analysis description
    This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=77.
    Comparison groups
    MPSK3169A 800 mg Q12W v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    77
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    64.7
         upper limit
    89.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.2
    Statistical analysis title
    Statistical analysis 46
    Statistical analysis description
    This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=106.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    64.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    54.5
         upper limit
    75
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.2
    Statistical analysis title
    Statistical analysis 47
    Statistical analysis description
    This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5761
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    3.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.2
         upper limit
    16.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.5
    Statistical analysis title
    Statistical analysis 48
    Statistical analysis description
    This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0002
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    23.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    11.3
         upper limit
    35.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.2
    Statistical analysis title
    Statistical analysis 49
    Statistical analysis description
    This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    42.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    32.4
         upper limit
    53.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.3
    Statistical analysis title
    Statistical analysis 50
    Statistical analysis description
    This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    76.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    63.3
         upper limit
    89.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.6
    Statistical analysis title
    Statistical analysis 51
    Statistical analysis description
    This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    71.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    62.3
         upper limit
    80.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.7
    Statistical analysis title
    Statistical analysis 52
    Statistical analysis description
    This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    50.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    38.5
         upper limit
    61.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.8
    Statistical analysis title
    Statistical analysis 53
    Statistical analysis description
    This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    60.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    49.4
         upper limit
    71.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.6
    Statistical analysis title
    Statistical analysis 54
    Statistical analysis description
    This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=102.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    68.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    59.1
         upper limit
    78.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.8
    Statistical analysis title
    Statistical analysis 55
    Statistical analysis description
    This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    74.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    63.2
         upper limit
    86.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    6
    Statistical analysis title
    Statistical analysis 56
    Statistical analysis description
    This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    61.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    52.4
         upper limit
    70.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.7
    Statistical analysis title
    Statistical analysis 57
    Statistical analysis description
    This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=79.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    34.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    23
         upper limit
    46.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.9
    Statistical analysis title
    Statistical analysis 58
    Statistical analysis description
    This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    60.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    50.1
         upper limit
    71.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.5
    Statistical analysis title
    Statistical analysis 59
    Statistical analysis description
    This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    67.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    58.6
         upper limit
    77.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.7
    Statistical analysis title
    Statistical analysis 60
    Statistical analysis description
    This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=78.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    55.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    43.7
         upper limit
    67.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    6
    Statistical analysis title
    Statistical analysis 61
    Statistical analysis description
    This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    65.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    56.8
         upper limit
    74.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.6
    Statistical analysis title
    Statistical analysis 62
    Statistical analysis description
    This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1512
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    8.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.1
         upper limit
    19.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.7
    Statistical analysis title
    Statistical analysis 63
    Statistical analysis description
    This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=86.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    40
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    29.5
         upper limit
    50.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.3
    Statistical analysis title
    Statistical analysis 64
    Statistical analysis description
    This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=100.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    60.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    51.3
         upper limit
    69.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.7
    Statistical analysis title
    Statistical analysis 65
    Statistical analysis description
    This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    29.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.2
         upper limit
    40.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.8

    Secondary: Percentage Change From Baseline (%CFB) in LDLc Concentration at all Other Time Points

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    End point title
    Percentage Change From Baseline (%CFB) in LDLc Concentration at all Other Time Points
    End point description
    mITT population participants with baseline and at least 1 post baseline measurement of LDLc concentration were included in the analysis of this end point. “n” value indicates the number of participants evaluable at a specified timepoint for a particular treatment arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 8, 15, 22, 29, 43, 57, 71, 85, 99, 113, 120, 141, and 155
    End point values
    MPSK3169A 400 mg once every 4 weeks (Q4W) MPSK3169A 200 mg Q8W MPSK3169A 400 mg Q8W MPSK3169A 800 mg Q8W MPSK3169A 800 mg Q12W Placebo
    Number of subjects analysed
    53
    23
    28
    49
    23
    63
    Units: percentage change
    arithmetic mean (standard deviation)
        Day 8 (n=50,23,25,43,22,60)
    -55.9 ± 16.1
    -52.1 ± 19.2
    -53.3 ± 18.6
    -55.9 ± 18.7
    -53.4 ± 18.5
    -6.7 ± 14.9
        Day 15 (n=50,23,28,44,20,61)
    -65.6 ± 17.9
    -54.6 ± 18.6
    -60.4 ± 16.2
    -67.4 ± 16.8
    -62.2 ± 16.9
    -9 ± 16.4
        Day 22 (n=47,23,28,47,23,61)
    -66.1 ± 14
    -50.9 ± 16.2
    -62.3 ± 13.4
    -68.3 ± 15.1
    -64 ± 20.1
    -6.5 ± 18.5
        Day 29 (n=49,23,28,49,21,63)
    -60 ± 17.2
    -36.5 ± 16.3
    -56.8 ± 14.6
    -66.4 ± 16.7
    -64.5 ± 18.1
    -5.6 ± 18.9
        Day 43 (n=50,22,26,46,23,61)
    -69.6 ± 17.3
    -20 ± 15.1
    -46.2 ± 14.2
    -59.7 ± 16.4
    -57.3 ± 21.1
    -6.3 ± 18.7
        Day 57 (n=53,23,28,48,22,58)
    -62.5 ± 20.2
    -10.1 ± 19
    -24.8 ± 17.8
    -48 ± 17.3
    -52 ± 15.7
    -3.9 ± 20.8
        Day 71 (n=53,20,27,46,22,59)
    -69.5 ± 18.5
    -57.7 ± 15.6
    -64.4 ± 15
    -68.7 ± 17.1
    -29.6 ± 19.2
    -6.2 ± 17.7
        Day 85 (n=53,23,28,47,22,61)
    -60.6 ± 24.9
    -41.9 ± 17.5
    -55.7 ± 13.3
    -65.5 ± 15.7
    -16.8 ± 17.1
    -9 ± 20.5
        Day 99 (n=50,23,28,44,20,57)
    -66.6 ± 19.8
    -17.2 ± 18.3
    -44.1 ± 15.6
    -57.8 ± 18
    -66.8 ± 18.4
    -5.3 ± 19.7
        Day 113 (n=48,23,27,45,22,58)
    -61.7 ± 19.3
    -10.9 ± 19
    -25.5 ± 18.5
    -45.4 ± 22
    -66.1 ± 14.9
    -7.4 ± 18.3
        Day 120 (n=47,23,27,44,22,58)
    -66.7 ± 15.9
    -49.1 ± 16.2
    -56.7 ± 17.2
    -65.7 ± 17.8
    -63.9 ± 13.5
    -5.7 ± 20.6
        Day 141 (n=48,22,27,46,21,57)
    -58.9 ± 22.7
    -36.7 ± 16.8
    -57.6 ± 12.7
    -65 ± 17.1
    -50.9 ± 14.2
    -7.7 ± 19.2
        Day 155 (n=47,22,28,42,22,58)
    -64.6 ± 20.8
    -16.9 ± 18.7
    -42.5 ± 15.5
    -61 ± 16.3
    -31.7 ± 16.2
    -9.7 ± 17.6
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    This analysis was performed on Day 8. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=110.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    47.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    41
         upper limit
    54
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.3
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    This analysis was performed on Day 8. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    45.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    36.9
         upper limit
    53.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.1
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    This analysis was performed on Day 8. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    46
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    38
         upper limit
    54
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.1
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    This analysis was performed on Day 8. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.
    Comparison groups
    MPSK3169A 800 mg Q8W v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    48.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    41.5
         upper limit
    55
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.4
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    This analysis was performed on Day 8. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=82.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    45.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    37.4
         upper limit
    54.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.2
    Statistical analysis title
    Statistical analysis 6
    Statistical analysis description
    This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=111.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    55.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    49.4
         upper limit
    62.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.3
    Statistical analysis title
    Statistical analysis 7
    Statistical analysis description
    This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    45.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    37.4
         upper limit
    53.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.2
    Statistical analysis title
    Statistical analysis 8
    Statistical analysis description
    This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    51.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    43.7
         upper limit
    59.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.9
    Statistical analysis title
    Statistical analysis 9
    Statistical analysis description
    This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    58.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    51.5
         upper limit
    64.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.4
    Statistical analysis title
    Statistical analysis 10
    Statistical analysis description
    This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    53.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    44.5
         upper limit
    61.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.4
    Statistical analysis title
    Statistical analysis 11
    Statistical analysis description
    This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=108.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    59
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    52.7
         upper limit
    65.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.2
    Statistical analysis title
    Statistical analysis 12
    Statistical analysis description
    This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    44.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    36.4
         upper limit
    52.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    4
    Statistical analysis title
    Statistical analysis 13
    Statistical analysis description
    This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    55.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    48
         upper limit
    62.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.8
    Statistical analysis title
    Statistical analysis 14
    Statistical analysis description
    This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=108.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    61.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    55.2
         upper limit
    67.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.2
    Statistical analysis title
    Statistical analysis 15
    Statistical analysis description
    This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    57.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    49.2
         upper limit
    65.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    4
    Statistical analysis title
    Statistical analysis 16
    Statistical analysis description
    This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=112.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    54.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    47.8
         upper limit
    61
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.3
    Statistical analysis title
    Statistical analysis 17
    Statistical analysis description
    This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=86.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    30.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    22.5
         upper limit
    39.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.2
    Statistical analysis title
    Statistical analysis 18
    Statistical analysis description
    Statistical analysis 18 This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). ). Number of subjects included in analysis=91.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    51
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    43.2
         upper limit
    58.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    4
    Statistical analysis title
    Statistical analysis 19
    Statistical analysis description
    This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=112.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    60.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    54.1
         upper limit
    67.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.3
    Statistical analysis title
    Statistical analysis 20
    Statistical analysis description
    This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    58.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    50.1
         upper limit
    67.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.4
    Statistical analysis title
    Statistical analysis 21
    Statistical analysis description
    This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=111.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    63.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    57.2
         upper limit
    70.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.4
    Statistical analysis title
    Statistical analysis 22
    Statistical analysis description
    This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0019
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    13.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.1
         upper limit
    22.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.3
    Statistical analysis title
    Statistical analysis 23
    Statistical analysis description
    This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=87.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    39.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    31.6
         upper limit
    47.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.1
    Statistical analysis title
    Statistical analysis 24
    Statistical analysis description
    This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    53.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    46.7
         upper limit
    60.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.4
    Statistical analysis title
    Statistical analysis 25
    Statistical analysis description
    This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    51.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    42.6
         upper limit
    59.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.3
    Statistical analysis title
    Statistical analysis 26
    Statistical analysis description
    This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=111.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    59.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    52.1
         upper limit
    66.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.7
    Statistical analysis title
    Statistical analysis 27
    Statistical analysis description
    This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1812
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    6.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.9
         upper limit
    15.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.7
    Statistical analysis title
    Statistical analysis 28
    Statistical analysis description
    This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=86.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    21.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    12.6
         upper limit
    30
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.4
    Statistical analysis title
    Statistical analysis 29
    Statistical analysis description
    This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=106.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    44.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    37.1
         upper limit
    51.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.7
    Statistical analysis title
    Statistical analysis 30
    Statistical analysis description
    This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    48.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    39
         upper limit
    57.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.8
    Statistical analysis title
    Statistical analysis 31
    Statistical analysis description
    This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=112.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    62.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    55.8
         upper limit
    69
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.3
    Statistical analysis title
    Statistical analysis 32
    Statistical analysis description
    This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=79.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    51.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    42.2
         upper limit
    60
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.5
    Statistical analysis title
    Statistical analysis 33
    Statistical analysis description
    This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=86.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    57.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    49.2
         upper limit
    65.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.1
    Statistical analysis title
    Statistical analysis 34
    Statistical analysis description
    This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    61.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    54.8
         upper limit
    68.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.5
    Statistical analysis title
    Statistical analysis 35
    Statistical analysis description
    This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    22.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    14.2
         upper limit
    31.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.4
    Statistical analysis title
    Statistical analysis 36
    Statistical analysis description
    This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=114.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    51.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    44
         upper limit
    58.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.7
    Statistical analysis title
    Statistical analysis 37
    Statistical analysis description
    This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    32.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    23.3
         upper limit
    42
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.8
    Statistical analysis title
    Statistical analysis 38
    Statistical analysis description
    This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    45.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    37.1
         upper limit
    54.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.5
    Statistical analysis title
    Statistical analysis 39
    Statistical analysis description
    This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=108.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    55.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    48.3
         upper limit
    63.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.8
    Statistical analysis title
    Statistical analysis 40
    Statistical analysis description
    This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1312
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    7.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.2
         upper limit
    16.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.8
    Statistical analysis title
    Statistical analysis 41
    Statistical analysis description
    This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    61.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    53.9
         upper limit
    68.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.7
    Statistical analysis title
    Statistical analysis 42
    Statistical analysis description
    This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0115
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    11.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.7
         upper limit
    20.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.6
    Statistical analysis title
    Statistical analysis 43
    Statistical analysis description
    This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    38.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    29.8
         upper limit
    47
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.4
    Statistical analysis title
    Statistical analysis 44
    Statistical analysis description
    This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=101.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    52
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    44.4
         upper limit
    59.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.8
    Statistical analysis title
    Statistical analysis 45
    Statistical analysis description
    This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=77.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    61.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    51.7
         upper limit
    70.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.9
    Statistical analysis title
    Statistical analysis 46
    Statistical analysis description
    This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    54.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    46.7
         upper limit
    61.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.8
    Statistical analysis title
    Statistical analysis 47
    Statistical analysis description
    This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4651
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    3.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.9
         upper limit
    12.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.7
    Statistical analysis title
    Statistical analysis 48
    Statistical analysis description
    This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    17.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    8.9
         upper limit
    26.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.5
    Statistical analysis title
    Statistical analysis 49
    Statistical analysis description
    This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    37.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    30
         upper limit
    45.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.9
    Statistical analysis title
    Statistical analysis 50
    Statistical analysis description
    This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    58.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    49.1
         upper limit
    68
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.8
    Statistical analysis title
    Statistical analysis 51
    Statistical analysis description
    This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    60.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    53.4
         upper limit
    67.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.5
    Statistical analysis title
    Statistical analysis 52
    Statistical analysis description
    This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    43.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    34.8
         upper limit
    51.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.3
    Statistical analysis title
    Statistical analysis 53
    Statistical analysis description
    This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    50.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    42.2
         upper limit
    58.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.1
    Statistical analysis title
    Statistical analysis 54
    Statistical analysis description
    This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=102.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    59.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    52.4
         upper limit
    66.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.6
    Statistical analysis title
    Statistical analysis 55
    Statistical analysis description
    This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    57.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    49.1
         upper limit
    66.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.4
    Statistical analysis title
    Statistical analysis 56
    Statistical analysis description
    This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    50.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    43.8
         upper limit
    58.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.6
    Statistical analysis title
    Statistical analysis 57
    Statistical analysis description
    This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=79.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    28.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    19.9
         upper limit
    38
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.6
    Statistical analysis title
    Statistical analysis 58
    Statistical analysis description
    This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    49.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    40.8
         upper limit
    57.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.3
    Statistical analysis title
    Statistical analysis 59
    Statistical analysis description
    This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    56.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    49.4
         upper limit
    63.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.7
    Statistical analysis title
    Statistical analysis 60
    Statistical analysis description
    This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=78.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    42.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    33.5
         upper limit
    51.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.7
    Statistical analysis title
    Statistical analysis 61
    Statistical analysis description
    This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    48
         upper limit
    62
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.5
    Statistical analysis title
    Statistical analysis 62
    Statistical analysis description
    This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1094
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    7.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.6
         upper limit
    15.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.4
    Statistical analysis title
    Statistical analysis 63
    Statistical analysis description
    This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=86.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    32.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    24.2
         upper limit
    40.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.1
    Statistical analysis title
    Statistical analysis 64
    Statistical analysis description
    This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=100.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    51
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    43.8
         upper limit
    58.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.6
    Statistical analysis title
    Statistical analysis 65
    Statistical analysis description
    This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDL−c (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.
    Comparison groups
    MPSK3169A 800 mg Q12W v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    21.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    13.1
         upper limit
    30.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.5

    Secondary: Absolute CFB in Total Cholesterol (TC), Non-High Density Lipoprotein (Non-HDL-c), and Apolipoprotein B (ApoB) at Day 169 and at Nadir

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    End point title
    Absolute CFB in Total Cholesterol (TC), Non-High Density Lipoprotein (Non-HDL-c), and Apolipoprotein B (ApoB) at Day 169 and at Nadir
    End point description
    Nadir is defined as the planned visit, up to day 169, with the greatest mean decrease within a treatment group. mITT population participants with baseline and at least 1 post baseline measurement of TC, non-HDLc and ApoB levels were included in the analysis of this end point. “n” value indicates the number of participants evaluable at a specified timepoint for a particular treatment arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 169, up to Day 169 (Nadir)
    End point values
    MPSK3169A 400 mg once every 4 weeks (Q4W) MPSK3169A 200 mg Q8W MPSK3169A 400 mg Q8W MPSK3169A 800 mg Q8W MPSK3169A 800 mg Q12W Placebo
    Number of subjects analysed
    52
    23
    28
    47
    21
    62
    Units: mg/dL
    arithmetic mean (standard deviation)
        CFB in TC at Day 169 (n=47,23,28,44,21,60)
    -75.4 ± 28.2
    -12.1 ± 26.9
    -33.6 ± 38.8
    -56.9 ± 35.6
    -27.3 ± 25.9
    -11.5 ± 29.7
        CFB in TC at nadir (n=52,23,27,47,20,62)
    -92.1 ± 33.2
    -70.4 ± 21.4
    -84.7 ± 29.4
    -92.3 ± 31
    -93.6 ± 27.5
    -10.4 ± 23.2
        CFB in non-HDLc at Day 169 (n=47,23,28,44,21,60)
    -78.6 ± 28.3
    -13.1 ± 28.7
    -34.9 ± 35.4
    -59.7 ± 38.1
    -27.9 ± 27
    -11 ± 28.6
        CFB in non-HDL-c at nadir (n=51,23,27,47,20,62)
    -95.5 ± 33.6
    -74.4 ± 18.7
    -88.7 ± 31.2
    -94.5 ± 30.6
    -95.4 ± 30.1
    -10.7 ± 23.2
        CFB in ApoB at Day 169 (n=47,23,28,44,21,60)
    -48.5 ± 19.2
    -5 ± 18.2
    -18.5 ± 20
    -37.1 ± 22.5
    -15.8 ± 15.4
    -5.8 ± 16.1
        CFB in ApoB at nadir (n=52,23,27,47,20,62)
    -59.5 ± 21.3
    -44.6 ± 14.8
    -53.4 ± 18.6
    -59.5 ± 18.5
    -59.2 ± 21.1
    -5.9 ± 14.1
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    63.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    51.4
         upper limit
    74.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.9
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.
    Comparison groups
    MPSK3169A 200 mg Q8W v Placebo
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9833
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    -0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.7
         upper limit
    14.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.4
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=88.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0047
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    19.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.2
         upper limit
    33.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    7
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=104.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    43.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    31.3
         upper limit
    55.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    6
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0488
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    15.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.1
         upper limit
    30.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.7
    Statistical analysis title
    Statistical analysis 6
    Statistical analysis description
    This analysis was performed for TC parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=114.
    Comparison groups
    MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    81.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    71.3
         upper limit
    91.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.1
    Statistical analysis title
    Statistical analysis 7
    Statistical analysis description
    This analysis was performed for TC parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    59.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    46.3
         upper limit
    72
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.5
    Statistical analysis title
    Statistical analysis 8
    Statistical analysis description
    This analysis was performed for TC parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    71.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    59.2
         upper limit
    83.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.2
    Statistical analysis title
    Statistical analysis 9
    Statistical analysis description
    This analysis was performed for TC parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=109.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    79.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    69
         upper limit
    89.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.2
    Statistical analysis title
    Statistical analysis 10
    Statistical analysis description
    This analysis was performed for TC parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=82.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    81.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    68.3
         upper limit
    95.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.9
    Statistical analysis title
    Statistical analysis 11
    Statistical analysis description
    This analysis was performed for non-HDLc parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    67.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    55.6
         upper limit
    79.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    6
    Statistical analysis title
    Statistical analysis 12
    Statistical analysis description
    This analysis was performed for non-HDLc parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.8377
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    1.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -13.1
         upper limit
    16.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.4
    Statistical analysis title
    Statistical analysis 13
    Statistical analysis description
    This analysis was performed for non-HDLc parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=88.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0017
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    22.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    8.4
         upper limit
    36
    Variability estimate
    Standard error of the mean
    Dispersion value
    7
    Statistical analysis title
    Statistical analysis 14
    Statistical analysis description
    This analysis was performed for non-HDLc parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=104.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    47
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    35
         upper limit
    59
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.1
    Statistical analysis title
    Statistical analysis 15
    Statistical analysis description
    This analysis was performed for non-HDLc parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.334
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    16.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.3
         upper limit
    31.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.7
    Statistical analysis title
    Statistical analysis 16
    Statistical analysis description
    This analysis was performed for non-HDLc parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=114.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    84.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    74.3
         upper limit
    94.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.2
    Statistical analysis title
    Statistical analysis 17
    Statistical analysis description
    This analysis was performed for non-HDLc parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    62.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    49.9
         upper limit
    75.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.6
    Statistical analysis title
    Statistical analysis 18
    Statistical analysis description
    This analysis was performed for non-HDLc parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    75.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    62.9
         upper limit
    87.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.3
    Statistical analysis title
    Statistical analysis 19
    Statistical analysis description
    This analysis was performed for non-HDLc parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=109.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    81.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    70.9
         upper limit
    91.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.2
    Statistical analysis title
    Statistical analysis 20
    Statistical analysis description
    This analysis was performed for non-HDLc parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=82.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    83.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    69.7
         upper limit
    97.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.9
    Statistical analysis title
    Statistical analysis 21
    Statistical analysis description
    This analysis was performed for Apo-B parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    42.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    35.4
         upper limit
    49.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.6
    Statistical analysis title
    Statistical analysis 22
    Statistical analysis description
    This analysis was performed for Apo-B parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.786
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    -1.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.1
         upper limit
    7.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.5
    Statistical analysis title
    Statistical analysis 23
    Statistical analysis description
    This analysis was performed for Apo-B parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=88.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.006
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    11.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.4
         upper limit
    20.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.2
    Statistical analysis title
    Statistical analysis 24
    Statistical analysis description
    This analysis was performed for Apo-B parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=104.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    30.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    23.1
         upper limit
    37.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.7
    Statistical analysis title
    Statistical analysis 25
    Statistical analysis description
    This analysis was performed for Apo-B parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0381
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    9.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.5
         upper limit
    18.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.6
    Statistical analysis title
    Statistical analysis 26
    Statistical analysis description
    This analysis was performed for Apo-B parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=114.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    53.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    46.8
         upper limit
    59.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.3
    Statistical analysis title
    Statistical analysis 27
    Statistical analysis description
    This analysis was performed for Apo-B parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    38.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    29.9
         upper limit
    46.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.2
    Statistical analysis title
    Statistical analysis 28
    Statistical analysis description
    This analysis was performed for Apo-B parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    45.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    37.8
         upper limit
    53.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    4
    Statistical analysis title
    Statistical analysis 29
    Statistical analysis description
    This analysis was performed for Apo-B parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=109.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    52
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    45.4
         upper limit
    58.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.4
    Statistical analysis title
    Statistical analysis 30
    Statistical analysis description
    This analysis was performed for Apo-B parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=82.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    52.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    43.7
         upper limit
    61.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.4

    Secondary: Percentage CFB in TC, Non-HDL-c, and ApoB at Day 169 and At Nadir

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    End point title
    Percentage CFB in TC, Non-HDL-c, and ApoB at Day 169 and At Nadir
    End point description
    Nadir is defined as the planned visit, up to day 169, with the greatest mean decrease within a treatment group. mITT population participants with baseline and at least 1 post baseline measurement of TC, non-HDLc and ApoB levels were included in the analysis of this end point. “n” value indicates the number of participants evaluable at a specified timepoint for a particular treatment arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 169, up to Day 169 (nadir)
    End point values
    MPSK3169A 400 mg once every 4 weeks (Q4W) MPSK3169A 200 mg Q8W MPSK3169A 400 mg Q8W MPSK3169A 800 mg Q8W MPSK3169A 800 mg Q12W Placebo
    Number of subjects analysed
    52
    23
    28
    47
    21
    62
    Units: percentage change
    arithmetic mean (standard deviation)
        % CFB in TC at Day 169 (n=47,23,28,44,21,60)
    -37 ± 11.7
    -5.8 ± 12.5
    -14.6 ± 15.9
    -27.3 ± 15.9
    -12.2 ± 10.8
    -5.5 ± 14.3
        % CFB in TC at nadir (n=52,23,27,47,20,62)
    -45.5 ± 13
    -35.9 ± 11.2
    -40.8 ± 10.4
    -44.2 ± 12.2
    -45.9 ± 12.3
    -5.2 ± 11.8
        % CFB in non-HDLc at Day 169 (n=47,23,28,44,21,60)
    -51.5 ± 14.7
    -8.4 ± 17.4
    -20.4 ± 19.1
    -38.3 ± 21.1
    -15.8 ± 14
    -6.8 ± 18.4
        % CFB in non-HDL-c at nadir (n=51,23,27,47,20,62)
    -63.1 ± 15.6
    -50.8 ± 12.9
    -57.1 ± 15
    -60.1 ± 13.3
    -60.8 ± 16.1
    -7.3 ± 14.8
        % CFB in ApoB at Day 169 (n=47,23,28,44,21,60)
    -46.7 ± 16.5
    -5 ± 15.7
    -16.6 ± 17.7
    -35.6 ± 18.7
    -13.3 ± 12.2
    -5 ± 16
        % CFB in ApoB at nadir (n=52,23,27,47,20,62)
    -58.1 ± 16
    -45.1 ± 14.1
    -51.9 ± 13.7
    -56.6 ± 13.1
    -55.7 ± 17.2
    -5.7 ± 13.5
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    31.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    26
         upper limit
    36.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.7
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9878
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.6
         upper limit
    6.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.4
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=88.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0077
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    8.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.3
         upper limit
    14.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.2
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=104.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    21.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    15.8
         upper limit
    26.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.8
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q12W
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0643
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    6.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.4
         upper limit
    13.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.5
    Statistical analysis title
    Statistical analysis 6
    Statistical analysis description
    This analysis was performed for TC parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=114.
    Comparison groups
    Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    39.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    35.4
         upper limit
    44.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.3
    Statistical analysis title
    Statistical analysis 7
    Statistical analysis description
    This analysis was performed for TC parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.
    Comparison groups
    Placebo v MPSK3169A 200 mg Q8W
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    30.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    24.8
         upper limit
    36.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.9
    Statistical analysis title
    Statistical analysis 8
    Statistical analysis description
    This analysis was performed for TC parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.
    Comparison groups
    Placebo v MPSK3169A 400 mg Q8W
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    34.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    29.4
         upper limit
    40.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.8
    Statistical analysis title
    Statistical analysis 9
    Statistical analysis description
    This analysis was performed for TC parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=109.
    Comparison groups
    Placebo v MPSK3169A 800 mg Q8W
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    38.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    33.8
         upper limit
    43
    Variability estimate
    Standard error of the mean