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    Clinical Trial Results:
    A Placebo-Controlled, Double-Blind, Randomized Phase 2 Study to Evaluate the Effect of Obicetrapib in Combination with Ezetimibe in Participants with Mild Dyslipidemia

    Summary
    EudraCT number
    		 2019-004935-22
    Trial protocol
    		 NL  
    Global end of trial date
    30 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Sep 2024
    First version publication date
    22 Sep 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TA-8995-303
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04770389
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Nickname:: OCEAN
    Sponsors
    Sponsor organisation name
    NewAmsterdam Pharma BV
    Sponsor organisation address
    Gooimeer 2-35 , DC Naarden , Netherlands, 1411
    Public contact
    Study Director, NewAmsterdam Pharma BV, +31 352062971, study.director@newamsterdampharma.com
    Scientific contact
    Study Director, NewAmsterdam Pharma BV, +31 352062971, study.director@newamsterdampharma.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
    12 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 May 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the effect of obicetrapib in combination with ezetimibe compared to placebo on low-density lipoprotein cholesterol (LDL-C) at Day 57.
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki and with all applicable laws and regulations of the locale and country where the study was conducted, and in compliance with Good Clinical Practice Guidelines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Oct 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 95
    Country: Number of subjects enrolled
    United States: 17
    Worldwide total number of subjects
    112
    EEA total number of subjects
    95
    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)
    90
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 112 participants were randomized. One participant in the ezetimibe monotherapy 10 mg group was randomized in error and did not participate in the study or receive study drug.

    Pre-assignment
    Screening details
    		 234 participants were screened

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching placebo tablet (ezetimibe)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily matching placebo tablet (ezetimibe)

    Investigational medicinal product name
    Matching placebo tablet (obicetrapib)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily matching placebo tablet (obicetrapib)

    Arm title
    		 Combination Therapy
    Arm description
    		 5 mg obicetrapib + 10 mg ezetimibe; once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Obicetrapib 5 mg tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily 5 mg obicetrapib tablet

    Investigational medicinal product name
    Ezetimibe 10 mg tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily 10 mg ezetimibe tablet

    Arm title
    		 Obicetrapib Monotherapy
    Arm description
    		 5 mg obicetrapib + placebo ezetimibe; once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Obicetrapib 5 mg tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily 5 mg obicetrapib tablet

    Investigational medicinal product name
    Matching placebo tablet (ezetimibe)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily matching placebo tablet (ezetimibe)

    Arm title
    		 Ezetimibe Monotherapy
    Arm description
    		 placebo obicetrapib + 10 mg ezetimibe; once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ezetimibe 10 mg tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily 10 mg ezetimibe tablet

    Investigational medicinal product name
    Matching placebo tablet (obicetrapib)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily matching placebo tablet (obicetrapib)

    Number of subjects in period 1 [1]
    		Placebo Combination Therapy Obicetrapib Monotherapy Ezetimibe Monotherapy
    Started
    28
    27
    28
    28
    Completed
    26
    22
    26
    24
    Not completed
    2
    5
    2
    4
         Left the country
    -
    -
    1
    2
         Consent withdrawn by subject
    -
    2
    -
    -
         Adverse event, non-fatal
    1
    2
    1
    1
         Moved away from study site
    -
    1
    -
    -
         Lost to follow-up
    -
    -
    -
    1
         Failed attempt to draw blood
    1
    -
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. One participant in the ezetimibe monotherapy (10 mg) group was randomized in error and did not participate in the study or receive study drug

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Combination Therapy
    Reporting group description
    		 5 mg obicetrapib + 10 mg ezetimibe; once daily

    Reporting group title
    Obicetrapib Monotherapy
    Reporting group description
    		 5 mg obicetrapib + placebo ezetimibe; once daily

    Reporting group title
    Ezetimibe Monotherapy
    Reporting group description
    		 placebo obicetrapib + 10 mg ezetimibe; once daily

    Reporting group values
    		 Placebo Combination Therapy Obicetrapib Monotherapy Ezetimibe Monotherapy Total
    Number of subjects
    		 28 27 28 28 111
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.5 ( 9.81 ) 53.5 ( 11.43 ) 59.1 ( 7.50 ) 54.4 ( 9.55 ) -
    Gender categorical
    Units: Subjects
        Female
    		 16 16 14 14 60
        Male
    		 12 11 14 14 51
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 1 1
        Not Hispanic or Latino
    		 26 26 27 25 104
        Unknown or Not Reported
    		 2 1 1 2 6
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 3 5 4 4 16
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 1 0 1 0 2
        White
    		 24 22 23 24 93
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 0
    Baseline Low-Density Lipoprotein Cholesterol (LDL-C) Values
    Baseline LDL-C is defined as the last measurement prior to the first dose of study drug. LDL-C was calculated using the Friedewald Formula.
    Units: milligram per deciliter (mg/dL)
        arithmetic mean (standard deviation)
    		 136.8 ( 19.86 ) 132.2 ( 27.48 ) 127.5 ( 20.87 ) 120.0 ( 22.33 ) -
    Subject analysis sets

    Subject analysis set title
    Baseline Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. The Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

    Subject analysis sets values
    		 Baseline Population
    Number of subjects
    111
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    55.4 ( 9.78 )
    Gender categorical
    Units: Subjects
        Female
    60
        Male
    51
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    1
        Not Hispanic or Latino
    104
        Unknown or Not Reported
    6
    Race
    Units: Subjects
        American Indian or Alaska Native
    0
        Asian
    16
        Native Hawaiian or Other Pacific Islander
    0
        Black or African American
    2
        White
    93
        More than one race
    0
        Unknown or Not Reported
    0
    Baseline Low-Density Lipoprotein Cholesterol (LDL-C) Values
    Baseline LDL-C is defined as the last measurement prior to the first dose of study drug. LDL-C was calculated using the Friedewald Formula.
    Units: milligram per deciliter (mg/dL)
        arithmetic mean (standard deviation)
    131.13 ( 22.64 )

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Combination Therapy
    Reporting group description
    		 5 mg obicetrapib + 10 mg ezetimibe; once daily

    Reporting group title
    Obicetrapib Monotherapy
    Reporting group description
    		 5 mg obicetrapib + placebo ezetimibe; once daily

    Reporting group title
    Ezetimibe Monotherapy
    Reporting group description
    		 placebo obicetrapib + 10 mg ezetimibe; once daily

    Subject analysis set title
    Baseline Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. The Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

    Primary: 1. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] [Time Frame: 8 weeks]

    		 Close Top of page
    End point title
    		 1. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] [Time Frame: 8 weeks] [1]
    End point description
    Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Combination Therapy
    Number of subjects analysed
    27
    24
    Units: Percent Change from Baseline
        arithmetic mean (standard deviation)
    -0.17 ( 12.682 )
    -45.63 ( 21.677 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Combination Therapy v Placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -44.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -55.2
         upper limit
    		 -34.63
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.183
    Notes
    [2] - mixed model for repeated measures (MMRM) with missing at random assumption

    Primary: 2. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] [Time Frame: 8 weeks]

    		 Close Top of page
    End point title
    		 2. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] [Time Frame: 8 weeks] [3]
    End point description
    Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Combination Therapy
    Number of subjects analysed
    27
    24
    Units: Percent Change from Baseline
        median (full range (min-max))
    -1.40 (-20.9 to 33.6)
    -51.95 (-77.9 to 3.1)
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Combination Therapy
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [4]
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -44.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -55.2
         upper limit
    		 -34.63
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.183
    Notes
    [4] - mixed model for repeated measures (MMRM) with missing at random assumption

    Primary: 3. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] [Time Frame: 8 weeks]

    		 Close Top of page
    End point title
    		 3. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] [Time Frame: 8 weeks] [5]
    End point description
    LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Combination Therapy
    Number of subjects analysed
    28
    27
    Units: Percent Change from Baseline
        least squares mean (standard error)
    1.37 ( 3.604 )
    -43.55 ( 3.746 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Combination Therapy
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [6]
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -44.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -55.2
         upper limit
    		 -34.63
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.183
    Notes
    [6] - mixed model for repeated measures (MMRM) with missing at random assumption

    Primary: 4. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC]

    		 Close Top of page
    End point title
    		 4. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC] [7]
    End point description
    Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Combination Therapy
    Number of subjects analysed
    22
    24
    Units: Percent Change from Baseline
        arithmetic mean (standard deviation)
    -1.53 ( 15.105 )
    -44.38 ( 20.731 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Combination Therapy
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -43.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -54.29
         upper limit
    		 -32.36
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.517

    Primary: 5. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC]

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    End point title
    		 5. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC] [8]
    End point description
    Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Combination Therapy
    Number of subjects analysed
    22
    24
    Units: Percent Change from Baseline
        median (full range (min-max))
    -2.00 (-24.5 to 35.9)
    -51.40 (-69.6 to 8.1)
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Combination Therapy
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -43.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -54.29
         upper limit
    		 -32.36
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.517

    Primary: 6. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC]

    		 Close Top of page
    End point title
    		 6. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC] [9]
    End point description
    LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Combination Therapy
    Number of subjects analysed
    22
    24
    Units: Percent Change from Baseline
        least squares mean (standard error)
    -0.78 ( 4.012 )
    -44.10 ( 3.813 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Combination Therapy
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -43.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -54.29
         upper limit
    		 -32.36
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.517

    Secondary: 7. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald]

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    End point title
    		 7. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald] [10]
    End point description
    Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Obicetrapib Monotherapy
    Number of subjects analysed
    27
    25
    Units: Percent Change from Baseline
        arithmetic mean (standard deviation)
    -0.17 ( 12.682 )
    -31.88 ( 18.860 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Obicetrapib Monotherapy v Placebo
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -33.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -43.63
         upper limit
    		 -23.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.176

    Secondary: 8. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald]

    		 Close Top of page
    End point title
    		 8. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald] [11]
    End point description
    Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Obicetrapib Monotherapy
    Number of subjects analysed
    27
    25
    Units: Percent Change from Baseline
        median (full range (min-max))
    -1.40 (-20.9 to 33.6)
    -34.40 (-57.0 to 23.8)
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib Monotherapy
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -33.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -43.63
         upper limit
    		 -23.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.176

    Secondary: 9. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald]

    		 Close Top of page
    End point title
    		 9. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald] [12]
    End point description
    LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Obicetrapib Monotherapy
    Number of subjects analysed
    28
    28
    Units: Percent Change from Baseline
        least squares mean (standard error)
    1.37 ( 3.604 )
    -31.99 ( 3.686 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib Monotherapy
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -33.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -43.63
         upper limit
    		 -23.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.176

    Secondary: 10. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC]

    		 Close Top of page
    End point title
    		 10. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC] [13]
    End point description
    Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Obicetrapib Monotherapy
    Number of subjects analysed
    22
    25
    Units: Percent Change from Baseline
        arithmetic mean (standard deviation)
    -1.53 ( 15.105 )
    -27.94 ( 18.914 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib Monotherapy
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -28.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -39.32
         upper limit
    		 -17.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.596

    Secondary: 11. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC]

    		 Close Top of page
    End point title
    		 11. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC] [14]
    End point description
    Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Obicetrapib Monotherapy
    Number of subjects analysed
    22
    25
    Units: Percent Change from Baseline
        median (full range (min-max))
    -2.00 (-24.5 to 35.9)
    -30.10 (-56.7 to 19.1)
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib Monotherapy
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -28.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -39.32
         upper limit
    		 -17.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.596

    Secondary: 12. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC]

    		 Close Top of page
    End point title
    		 12. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC] [15]
    End point description
    LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Obicetrapib Monotherapy
    Number of subjects analysed
    22
    25
    Units: Percent Change from Baseline
        least squares mean (standard error)
    -0.78 ( 4.012 )
    -28.98 ( 3.802 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib Monotherapy
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -28.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -39.32
         upper limit
    		 -17.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.596

    Secondary: 13. Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo

    		 Close Top of page
    End point title
    		 13. Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [16]
    End point description
    Mean percent change in ApoB from baseline to Day 57
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Combination Therapy
    Number of subjects analysed
    27
    24
    Units: Percent Change from Baseline
        arithmetic mean (standard deviation)
    -1.17 ( 11.692 )
    -31.62 ( 15.521 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Combination Therapy v Placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -29.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.12
         upper limit
    		 -22.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.78

    Secondary: 14. Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo

    		 Close Top of page
    End point title
    		 14. Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [17]
    End point description
    Median percent change in ApoB from baseline to Day 57
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Combination Therapy
    Number of subjects analysed
    27
    24
    Units: Percent Change from Baseline
        median (full range (min-max))
    -0.90 (-19.8 to 25.4)
    -34.75 (-53.0 to 8.9)
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Combination Therapy
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -29.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.12
         upper limit
    		 -22.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.78

    Secondary: 15. LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo

    		 Close Top of page
    End point title
    		 15. LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [18]
    End point description
    LS Mean percent change in ApoB from baseline to Day 57
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Combination Therapy
    Number of subjects analysed
    28
    27
    Units: Percent Change from Baseline
        least squares mean (standard error)
    -0.11 ( 2.626 )
    -29.73 ( 2.730 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Combination Therapy
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -29.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.12
         upper limit
    		 -22.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.78

    Secondary: 16. Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo

    		 Close Top of page
    End point title
    		 16. Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [19]
    End point description
    Mean percent change in Apo-B from baseline to Day 57
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Obicetrapib Monotherapy
    Number of subjects analysed
    27
    26
    Units: Percent Change from Baseline
        arithmetic mean (standard deviation)
    -1.17 ( 11.692 )
    -22.15 ( 13.356 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib Monotherapy
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -22.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.83
         upper limit
    		 -14.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.768

    Secondary: 17. Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo

    		 Close Top of page
    End point title
    		 17. Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [20]
    End point description
    Median percent change in Apo-B from baseline to Day 57
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Obicetrapib Monotherapy
    Number of subjects analysed
    27
    26
    Units: Percent Change from Baseline
        median (full range (min-max))
    -0.90 (-19.8 to 25.4)
    -23.50 (-39.3 to 21.2)
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib Monotherapy
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -22.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.83
         upper limit
    		 -14.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.768

    Secondary: 18. LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo

    		 Close Top of page
    End point title
    		 18. LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [21]
    End point description
    LS Mean percent change in Apo-B from baseline to Day 57
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Obicetrapib Monotherapy
    Number of subjects analysed
    28
    28
    Units: Percent Change from Baseline
        least squares mean (standard error)
    -0.11 ( 2.626 )
    -22.46 ( 2.675 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib Monotherapy
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -22.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.83
         upper limit
    		 -14.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.768

    Secondary: 19. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald]

    		 Close Top of page
    End point title
    		 19. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald] [22]
    End point description
    Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Combination Therapy Ezetimibe Monotherapy
    Number of subjects analysed
    24
    25
    Units: Percent Change from Baseline
        arithmetic mean (standard deviation)
    -45.63 ( 21.677 )
    -12.69 ( 21.316 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Combination Therapy v Ezetimibe Monotherapy
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -30.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -40.55
         upper limit
    		 -19.71
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.254

    Secondary: 20. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald]

    		 Close Top of page
    End point title
    		 20. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald] [23]
    End point description
    Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Combination Therapy Ezetimibe Monotherapy
    Number of subjects analysed
    24
    25
    Units: Percent Change from Baseline
        median (full range (min-max))
    -51.95 (-77.9 to 3.1)
    -14.80 (-51.9 to 59.1)
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Combination Therapy v Ezetimibe Monotherapy
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -30.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -40.55
         upper limit
    		 -19.71
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.254

    Secondary: 21. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald]

    		 Close Top of page
    End point title
    		 21. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald] [24]
    End point description
    LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Combination Therapy Ezetimibe Monotherapy
    Number of subjects analysed
    27
    28
    Units: Percent Change from Baseline
        least squares mean (standard error)
    -43.55 ( 3.746 )
    -13.42 ( 3.675 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Combination Therapy v Ezetimibe Monotherapy
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -30.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -40.55
         upper limit
    		 -19.71
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.254

    Secondary: 22. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald]

    		 Close Top of page
    End point title
    		 22. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald] [25]
    End point description
    Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Obicetrapib Monotherapy Ezetimibe Monotherapy
    Number of subjects analysed
    25
    25
    Units: Percent Change from Baseline
        arithmetic mean (standard deviation)
    -31.88 ( 18.860 )
    -12.69 ( 21.316 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Obicetrapib Monotherapy v Ezetimibe Monotherapy
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -18.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.88
         upper limit
    		 -8.27
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.196

    Secondary: 23. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald]

    		 Close Top of page
    End point title
    		 23. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald] [26]
    End point description
    Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Obicetrapib Monotherapy Ezetimibe Monotherapy
    Number of subjects analysed
    25
    25
    Units: Percent Change from Baseline
        median (full range (min-max))
    -34.40 (-57.0 to 23.8)
    -14.80 (-51.9 to 59.1)
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Obicetrapib Monotherapy v Ezetimibe Monotherapy
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -18.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.88
         upper limit
    		 -8.27
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.196

    Secondary: 24. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald]

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    End point title
    		 24. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald] [27]
    End point description
    LS Mean percent change in LDL-C from baseline to Day 57; LDL-C calculated using the Friedewald formula
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Obicetrapib Monotherapy Ezetimibe Monotherapy
    Number of subjects analysed
    28
    28
    Units: Percent Change from Baseline
        least squares mean (standard error)
    -31.99 ( 3.686 )
    -13.42 ( 3.675 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Obicetrapib Monotherapy v Ezetimibe Monotherapy
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0005
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -18.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.88
         upper limit
    		 -8.27
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.196

    Secondary: 25. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald]

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    End point title
    		 25. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald] [28]
    End point description
    Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Ezetimibe Monotherapy
    Number of subjects analysed
    27
    25
    Units: Percent Change from Baseline
        arithmetic mean (standard deviation)
    -0.17 ( 12.682 )
    -12.69 ( 21.316 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Ezetimibe Monotherapy
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0051
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -14.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.03
         upper limit
    		 -4.54
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.165

    Secondary: 26. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald]

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    End point title
    		 26. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald] [29]
    End point description
    Median percent change in LDL-C from baseline to Day 57; LDL-C calculated using the Friedewald formula
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Ezetimibe Monotherapy
    Number of subjects analysed
    27
    25
    Units: Percent Change from Baseline
        median (full range (min-max))
    -1.40 (-20.9 to 33.6)
    -14.80 (-51.9 to 59.1)
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Ezetimibe Monotherapy
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0051
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -14.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.03
         upper limit
    		 -4.54
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.165

    Secondary: 27. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald]

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    End point title
    		 27. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald] [30]
    End point description
    LS Mean percent change in LDL-C from baseline to Day 57; LDL-C calculated using the Friedewald formula
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Ezetimibe Monotherapy
    Number of subjects analysed
    28
    28
    Units: Percent Change from Baseline
        least squares mean (standard error)
    1.37 ( 3.604 )
    -13.42 ( 3.675 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Ezetimibe Monotherapy
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0051
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -14.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.03
         upper limit
    		 -4.54
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.165

    Secondary: 28. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC]

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    End point title
    		 28. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC] [31]
    End point description
    Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Ezetimibe Monotherapy
    Number of subjects analysed
    22
    23
    Units: Percent Change from Baseline
        arithmetic mean (standard deviation)
    -1.53 ( 15.105 )
    -13.68 ( 19.573 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Ezetimibe Monotherapy
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0245
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -12.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.86
         upper limit
    		 -1.68
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.58

    Secondary: 29. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC]

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    End point title
    		 29. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC] [32]
    End point description
    Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Ezetimibe Monotherapy
    Number of subjects analysed
    22
    23
    Units: Percent Change from Baseline
        median (full range (min-max))
    -2.00 (-24.5 to 35.9)
    -14.90 (-46.8 to 46.9)
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Ezetimibe Monotherapy
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0245
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -12.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.86
         upper limit
    		 -1.68
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.58

    Secondary: 30. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC]

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    End point title
    		 30. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC] [33]
    End point description
    LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Placebo Ezetimibe Monotherapy
    Number of subjects analysed
    22
    23
    Units: Percent Change from Baseline
        least squares mean (standard error)
    -0.78 ( 4.012 )
    -13.55 ( 3.891 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Ezetimibe Monotherapy
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0245
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -12.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.86
         upper limit
    		 -1.68
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.58

    Secondary: 31. Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy

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    End point title
    		 31. Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [34]
    End point description
    Mean percent change in ApoB from baseline to Day 57
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Combination Therapy Ezetimibe Monotherapy
    Number of subjects analysed
    24
    25
    Units: Percent Change from Baseline
        arithmetic mean (standard deviation)
    -31.62 ( 15.521 )
    -8.78 ( 14.445 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Combination Therapy v Ezetimibe Monotherapy
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -20.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.39
         upper limit
    		 -13.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.822

    Secondary: 32. Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy

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    End point title
    		 32. Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [35]
    End point description
    Median percent change in ApoB from baseline to Day 57
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Combination Therapy Ezetimibe Monotherapy
    Number of subjects analysed
    24
    25
    Units: Percent Change from Baseline
        median (full range (min-max))
    -34.75 (-53.0 to 8.9)
    -8.90 (-45.4 to 32.3)
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Combination Therapy v Ezetimibe Monotherapy
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -20.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.39
         upper limit
    		 -13.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.822

    Secondary: 33. LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy

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    End point title
    		 33. LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [36]
    End point description
    LS Mean Percent change in ApoB from baseline to Day 57
    End point type
    Secondary
    End point timeframe
    8 weeks
    Notes
    [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point only includes a comparison of 2 arms
    End point values
    		 Combination Therapy Ezetimibe Monotherapy
    Number of subjects analysed
    27
    28
    Units: Percent Change from Baseline
        least squares mean (standard error)
    -29.73 ( 2.730 )
    -8.92 ( 2.675 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Combination Therapy v Ezetimibe Monotherapy
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -20.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.39
         upper limit
    		 -13.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.822

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug through Week 16
    Adverse event reporting additional description
    Safety Population included all participants who received at least 1 dose of any study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Combination Therapy
    Reporting group description
    		 5 mg obicetrapib + 10 mg ezetimibe; once daily

    Reporting group title
    Obicetrapib Monotherapy
    Reporting group description
    		 5 mg obicetrapib + placebo ezetimibe; once daily

    Reporting group title
    Ezetimibe Monotherapy
    Reporting group description
    		 placebo obicetrapib + 10 mg ezetimibe; once daily

    Serious adverse events
    		 Placebo Combination Therapy Obicetrapib Monotherapy Ezetimibe Monotherapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 28 (0.00%)
    2 / 28 (7.14%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Multiple fractures
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hyperventilation
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Combination Therapy Obicetrapib Monotherapy Ezetimibe Monotherapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 28 (21.43%)
    9 / 27 (33.33%)
    4 / 28 (14.29%)
    8 / 28 (28.57%)
    Investigations
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 27 (3.70%)
    0 / 28 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    2
    1
    0
    2
    Dizziness
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Sciatica
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 27 (7.41%)
    0 / 28 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    0
    3
    0
    2
    Constipation
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    1
    Abdominal pain
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Productive cough
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Nail fold inflammation
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    1
    Back pain
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bursitis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    1
    Temporomandibular joint syndrome
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    1
    0
    COVID-19
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    1
    Influenza
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Onychomycosis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jan 2021
    This amendment was written to address feedback from Competent Authorities and to mitigate the effects of the ongoing Coronavirus Disease 2019 (COVID-19) pandemic on the study’s execution. Key changes to the protocol with rationale were as follows: • The sample size was reduced from approximately 152 participants to approximately 100 participants (25 per group). o Rationale: To facilitate the completion of enrollment within an acceptable timeframe, whilst maintaining sufficient statistical power to address the scientific objectives of the study. • The geographical scope of the study was expanded to include the option for participation of sites in the USA. o Rationale: To mitigate the effects of the ongoing COVID-19 pandemic on site operations, recruitment, and participant retention. • The Treatment Period was reduced from 12 weeks to 8 weeks. o Rationale: To optimize participant retention and data completeness in the context of the COVID-19 pandemic, whilst maintaining the scientific integrity of the primary and secondary endpoints, which were still be evaluated at steady state for all study drugs. • The priority of some endpoints in the secondary endpoint hierarchy were revised. o Rationale: To focus on key scientific questions raised by recent interactions with Competent Authorities. • The analysis of LDL-C has been amended so that this parameter will be calculated by the Friedewald formula, with preparative ultracentrifugation also used for evaluation for changes between baseline and end of treatment (the primary endpoint). o Rationale: To optimize the analytical efficiency of the study, consistent with other studies in this indication. In addition, the lipid inclusion and exclusion criteria of the study and current scientific understanding about precision of the assessment of LDL-C levels by the Friedewald formula are such that an accurate assessment of the primary and key secondary endpoints can be guaranteed.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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