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    Clinical Trial Results:
    A Phase 2 Efficacy and Safety Dose-Ranging Study of LY3015014 in Patients with Primary Hypercholesterolemia

    Summary
    EudraCT number
    		 2013-000622-55
    Trial protocol
    		 CZ   NL   PL   DK  
    Global end of trial date
    06 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Jun 2017
    First version publication date
    10 Jun 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    I5S-MC-EFJE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01890967
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 14853
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, +1 877 CTLilly,
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, +1 877 285-4559,
    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
    06 Jun 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study is designed to define the amount and duration of cholesterol lowering and to assess the safety and tolerability of different dose regimens of LY3015014 in participants with high cholesterol. The study will also investigate how the body processes the drug and how the drug affects the body. Participants will remain on a stable diet and will continue taking cholesterol-lowering medications (statins with or without ezetimibe). After signing the informed consent document, the participant will complete a screening/run-in period that will last at most 8 weeks. Then, the treatment period will last approximately 16 weeks. After the treatment period, the participants will complete a follow-up period lasting approximately 8 weeks for a total study duration ranging from approximately 25 to 32 weeks.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 The study enrolled patients on a stable dose of standard of care (SOC) statin therapy (atorvastatin, simvastatin, rosuvastatin, pravastatin, lovastatin, fluvastatin, or pitavastatin, as approved per country regulations). In addition, a subset of patients who were intolerant of any dose of at least 1 statin was enrolled. Study patients could also be on a stable dose of ezetimibe (as approved per country regulations).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Jun 2013
    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
    Canada: 94
    Country: Number of subjects enrolled
    Netherlands: 88
    Country: Number of subjects enrolled
    Czech Republic: 23
    Country: Number of subjects enrolled
    Puerto Rico: 5
    Country: Number of subjects enrolled
    United States: 143
    Country: Number of subjects enrolled
    Japan: 106
    Country: Number of subjects enrolled
    Denmark: 29
    Country: Number of subjects enrolled
    Poland: 31
    Worldwide total number of subjects
    519
    EEA total number of subjects
    171
    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)
    373
    From 65 to 84 years
    146
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 No Text Entered

    Period 1
    Period 1 title
    Randomized
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo Q4W
    Arm description
    		 Placebo given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks.

    Arm title
    		 20 mg LY3015014 Q4W
    Arm description
    		 20 milligrams (mg) LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3015014
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    20 mg LY3015014 given SC Q4W for 16 weeks.

    Arm title
    		 120 mg LY3015014 Q4W
    Arm description
    		 120 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3015014
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    120 mg LY3015014 given SC every Q4W for 16 weeks.

    Arm title
    		 300 mg LY3015014 Q4W
    Arm description
    		 300 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3015014
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg LY3015014 given SC Q4W for 16 weeks.

    Arm title
    		 100 mg LY3015014 Q8W
    Arm description
    		 100 mg LY3015014 given SC once every 8 weeks (Q8W) for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3015014
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 mg LY3015014 given SC every 8 weeks (Q8W) for 16 weeks.

    Arm title
    		 300 mg LY3015014 Q8W
    Arm description
    		 300 mg LY3015014 given SC Q8W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3015014
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg LY3015014 given SC Q8W for 16 weeks.

    Number of subjects in period 1
    		Placebo Q4W 20 mg LY3015014 Q4W 120 mg LY3015014 Q4W 300 mg LY3015014 Q4W 100 mg LY3015014 Q8W 300 mg LY3015014 Q8W
    Started
    88
    88
    88
    88
    87
    88
    Completed
    87
    87
    86
    86
    86
    87
    Not completed
    1
    1
    2
    2
    1
    1
         Consent withdrawn by subject
    1
    -
    -
    -
    -
    -
         Met exclusion criteria
    -
    1
    2
    2
    1
    1
    Period 2
    Period 2 title
    Treated
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo Q4W
    Arm description
    		 Placebo given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks.

    Arm title
    		 20 mg LY3015014 Q4W
    Arm description
    		 20 milligrams (mg) LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3015014
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    20 mg LY3015014 given SC Q4W for 16 weeks.

    Arm title
    		 120 mg LY3015014 Q4W
    Arm description
    		 120 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3015014
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    120 mg LY3015014 given SC every Q4W for 16 weeks.

    Arm title
    		 300 mg LY3015014 Q4W
    Arm description
    		 300 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3015014
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg LY3015014 given SC Q4W for 16 weeks.

    Arm title
    		 100 mg LY3015014 Q8W
    Arm description
    		 100 mg LY3015014 given SC once every 8 weeks (Q8W) for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3015014
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 mg LY3015014 given SC every 8 weeks (Q8W) for 16 weeks.

    Arm title
    		 300 mg LY3015014 Q8W
    Arm description
    		 300 mg LY3015014 given SC Q8W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3015014
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg LY3015014 given SC Q8W for 16 weeks.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Participants in Period 1 (Randomization Phase) were randomly assigned to a dose dependent treatment arm; a total of 527 participants were randomized. Of the 527 randomized participants, 8 participants did not receive study drug. The 519 participants who actually received at least one dose of study drug in Period 2 (Treatment Phase) were included in the safety population, therefore Period 2 was used for the baseline period.
    Number of subjects in period 2
    		Placebo Q4W 20 mg LY3015014 Q4W 120 mg LY3015014 Q4W 300 mg LY3015014 Q4W 100 mg LY3015014 Q8W 300 mg LY3015014 Q8W
    Started
    87
    87
    86
    86
    86
    87
    Recieved at least one dose of study drug
    87
    87
    86
    86
    86
    87
    Completed
    79
    79
    80
    78
    76
    75
    Not completed
    8
    8
    6
    8
    10
    12
         Consent withdrawn by subject
    2
    3
    -
    3
    2
    -
         Adverse event, non-fatal
    3
    2
    4
    2
    1
    7
         Not specified
    2
    1
    1
    1
    4
    5
         Protocol Violation
    1
    2
    1
    2
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treated
    Reporting group description
    		 -

    Reporting group values
    		 Treated Total
    Number of subjects
    		 519 519
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 373 373
        From 65-84 years
    		 146 146
        85 years and over
    		 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 58.4 ( 10.2 ) -
    Gender, Male/Female
    Units:
        Male
    		 241 241
        Female
    		 278 278
    Region of Enrollment
    Units: Subjects
        Canada
    		 94 94
        Netherlands
    		 88 88
        Czech Republic
    		 23 23
        Puerto Rico
    		 5 5
        United States
    		 143 143
        Japan
    		 106 106
        Denmark
    		 29 29
        Poland
    		 31 31

    End points

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    End points reporting groups
    Reporting group title
    Placebo Q4W
    Reporting group description
    		 Placebo given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

    Reporting group title
    20 mg LY3015014 Q4W
    Reporting group description
    		 20 milligrams (mg) LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

    Reporting group title
    120 mg LY3015014 Q4W
    Reporting group description
    		 120 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

    Reporting group title
    300 mg LY3015014 Q4W
    Reporting group description
    		 300 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

    Reporting group title
    100 mg LY3015014 Q8W
    Reporting group description
    		 100 mg LY3015014 given SC once every 8 weeks (Q8W) for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

    Reporting group title
    300 mg LY3015014 Q8W
    Reporting group description
    		 300 mg LY3015014 given SC Q8W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
    Reporting group title
    Placebo Q4W
    Reporting group description
    		 Placebo given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

    Reporting group title
    20 mg LY3015014 Q4W
    Reporting group description
    		 20 milligrams (mg) LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

    Reporting group title
    120 mg LY3015014 Q4W
    Reporting group description
    		 120 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

    Reporting group title
    300 mg LY3015014 Q4W
    Reporting group description
    		 300 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

    Reporting group title
    100 mg LY3015014 Q8W
    Reporting group description
    		 100 mg LY3015014 given SC once every 8 weeks (Q8W) for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

    Reporting group title
    300 mg LY3015014 Q8W
    Reporting group description
    		 300 mg LY3015014 given SC Q8W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

    Primary: Percentage Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)

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    End point title
    		 Percentage Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
    End point description
    Least square (LS) Means was calculated using analysis of covariance (ANCOVA) adjusted for disease classification, statin dose, baseline LDL-C measurement. Percent change from baseline response is the dependent variable. The Analysis Population Description for the Modified-Intent-To-Treat population (mITT) is defined as all participants in the Intent-To-Treat (ITT) population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.
    End point type
    Primary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Q4W 20 mg LY3015014 Q4W 120 mg LY3015014 Q4W 300 mg LY3015014 Q4W 100 mg LY3015014 Q8W 300 mg LY3015014 Q8W
    Number of subjects analysed
    79 [1]
    73 [2]
    78 [3]
    76 [4]
    73 [5]
    73 [6]
    Units: Percentage change
        least squares mean (standard error)
    7.6 ( 2.27 )
    -14.9 ( 2.39 )
    -40.5 ( 2.31 )
    -50.5 ( 2.3 )
    -14.9 ( 2.35 )
    -37.1 ( 2.44 )
    Notes
    [1] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [2] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [3] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [4] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [5] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [6] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    Statistical analysis title
    		 20mg LY3015914 Q4W versus Placebo Q4W
    Comparison groups
    Placebo Q4W v 20 mg LY3015014 Q4W
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -22.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.5
         upper limit
    		 -16.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.02
    Statistical analysis title
    		 120mg LY3015014 Q4W versus Placebo Q4W
    Comparison groups
    Placebo Q4W v 120 mg LY3015014 Q4W
    Number of subjects included in analysis
    157
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -48.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -54
         upper limit
    		 -42.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.98
    Statistical analysis title
    		 LY3015014 300mg Q4W versus Placebo Q4W
    Comparison groups
    Placebo Q4W v 300 mg LY3015014 Q4W
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -58.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -64.1
         upper limit
    		 -52.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    3
    Statistical analysis title
    		 LY3015014 100mg Q8W versus Placebo Q4W
    Comparison groups
    100 mg LY3015014 Q8W v Placebo Q4W
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -22.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.5
         upper limit
    		 -16.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.03
    Statistical analysis title
    		 LY3015014 300mg Q8W versus Placebo Q4W
    Comparison groups
    Placebo Q4W v 300 mg LY3015014 Q8W
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -44.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -50.7
         upper limit
    		 -38.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.04

    Secondary: Percentage Change from Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C

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    End point title
    		 Percentage Change from Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C
    End point description
    LS Mean was calculated using mixed model repeated measures (MMRM) analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable. The mITT population is defined as all participants in the ITT population who had one baseline measurement and one post-randomization measurement of the variable that is analyzed. N for Reporting Groups 1,2,3,4,5,6 are as follows: LDL-C (n=78,77,78,78,77,73), TG (n=78,78,80,79,76,74), TC (n=78,78,80,79,76,74), HDL-C (n=78,78,80,79,76,74), Non-HDL-C (n=78,78,80,79,76,74), respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Q4W 20 mg LY3015014 Q4W 120 mg LY3015014 Q4W 300 mg LY3015014 Q4W 100 mg LY3015014 Q8W 300 mg LY3015014 Q8W
    Number of subjects analysed
    86 [7]
    86 [8]
    86 [9]
    85 [10]
    86 [11]
    87 [12]
    Units: Percentage change
    least squares mean (standard error)
        LDL-C
    5.9 ( 2.13 )
    -18 ( 2.18 )
    -46.4 ( 2.15 )
    -56.5 ( 2.14 )
    -18.4 ( 2.14 )
    -42.2 ( 2.21 )
        TG
    3.5 ( 3.26 )
    -6.1 ( 3.35 )
    -7.2 ( 3.25 )
    -15.1 ( 3.26 )
    -7.2 ( 3.29 )
    -10.6 ( 3.35 )
        TC
    3.5 ( 1.44 )
    -10.5 ( 1.47 )
    -27.8 ( 1.44 )
    -34.1 ( 1.44 )
    -11 ( 1.45 )
    -24.6 ( 1.48 )
        HDL-C
    1.6 ( 1.58 )
    4.5 ( 1.6 )
    7.3 ( 1.57 )
    8.8 ( 1.58 )
    4.5 ( 1.59 )
    8.4 ( 1.61 )
        Non-HDL-C
    4.9 ( 1.83 )
    -16.1 ( 1.86 )
    -39.3 ( 1.83 )
    -48.9 ( 1.83 )
    -16.1 ( 1.84 )
    -35.8 ( 1.88 )
    Notes
    [7] - All randomized participants who took at least 1 dose of double-blind study medication.
    [8] - All randomized participants who took at least 1 dose of double-blind study medication.
    [9] - All randomized participants who took at least 1 dose of double-blind study medication.
    [10] - All randomized participants who took at least 1 dose of double-blind study medication.
    [11] - All randomized participants who took at least 1 dose of double-blind study medication.
    [12] - All randomized participants who took at least 1 dose of double-blind study medication.
    No statistical analyses for this end point

    Secondary: Percentage Change from Baseline in Apolipoprotein A1 (Apo A1), Apolipoprotein B (Apo B)

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    End point title
    		 Percentage Change from Baseline in Apolipoprotein A1 (Apo A1), Apolipoprotein B (Apo B)
    End point description
    LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable. The mITT is defined as all participants in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Q4W 20 mg LY3015014 Q4W 120 mg LY3015014 Q4W 300 mg LY3015014 Q4W 100 mg LY3015014 Q8W 300 mg LY3015014 Q8W
    Number of subjects analysed
    78 [13]
    77 [14]
    78 [15]
    78 [16]
    75 [17]
    73 [18]
    Units: Percentage change
    least squares mean (standard error)
        Apolipoprotein A1
    0.3 ( 1.4 )
    2.4 ( 1.43 )
    6.5 ( 1.41 )
    6.2 ( 1.41 )
    3.8 ( 1.43 )
    5.8 ( 1.44 )
        Apolipoprotein B
    4.2 ( 2.23 )
    -16.6 ( 2.32 )
    -34.9 ( 2.28 )
    -46.8 ( 2.25 )
    -16 ( 2.25 )
    -31.9 ( 2.31 )
    Notes
    [13] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement .
    [14] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [15] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [16] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [17] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [18] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    No statistical analyses for this end point

    Secondary: Percentage Change From Baseline in Lipoprotein(a) [Lp(a)]

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    End point title
    		 Percentage Change From Baseline in Lipoprotein(a) [Lp(a)]
    End point description
    Data was log-transformed for MMRM analysis, with change from baseline as the dependent variable, and baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included as independent variables. Percentage change from baseline in the original scale was then back-calculated from the log-transformed MMRM analysis. The mITT is defined as all participants in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Q4W 20 mg LY3015014 Q4W 120 mg LY3015014 Q4W 300 mg LY3015014 Q4W 100 mg LY3015014 Q8W 300 mg LY3015014 Q8W
    Number of subjects analysed
    68 [19]
    71 [20]
    73 [21]
    75 [22]
    70 [23]
    68 [24]
    Units: Percentage Change
        least squares mean (standard error)
    -0.31 ( 0.0436 )
    -16.63 ( 0.0442 )
    -19.02 ( 0.0427 )
    -37.29 ( 0.042 )
    -7.54 ( 0.0427 )
    -21.01 ( 0.0437 )
    Notes
    [19] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [20] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [21] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [22] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [23] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [24] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    No statistical analyses for this end point

    Secondary: Change from Baseline in high sensitivity C-Reactive Protein (hsCRP)

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    End point title
    		 Change from Baseline in high sensitivity C-Reactive Protein (hsCRP)
    End point description
    LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable. The mITT is defined as all participants in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Q4W 20 mg LY3015014 Q4W 120 mg LY3015014 Q4W 300 mg LY3015014 Q4W 100 mg LY3015014 Q8W 300 mg LY3015014 Q8W
    Number of subjects analysed
    78 [25]
    75 [26]
    80 [27]
    78 [28]
    76 [29]
    73 [30]
    Units: Percentage change
        least squares mean (standard error)
    0.5 ( 0.7 )
    -0.2 ( 0.72 )
    1.6 ( 0.69 )
    -0.3 ( 0.7 )
    -0.3 ( 0.7 )
    -0.7 ( 0.72 )
    Notes
    [25] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [26] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [27] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [28] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [29] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [30] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    No statistical analyses for this end point

    Secondary: Number of Participants Who Develop Treatment Emergent Anti-LY3015014 Antibodies

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    End point title
    		 Number of Participants Who Develop Treatment Emergent Anti-LY3015014 Antibodies
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline through Week 24
    End point values
    		 Placebo Q4W 20 mg LY3015014 Q4W 120 mg LY3015014 Q4W 300 mg LY3015014 Q4W 100 mg LY3015014 Q8W 300 mg LY3015014 Q8W
    Number of subjects analysed
    86 [31]
    86 [32]
    86
    85 [33]
    86
    87
    Units: Participants
        number (not applicable)
    4
    6
    10
    5
    4
    3
    Notes
    [31] - All randomized participants who received at least 1 dose of study treatment and had evaluable data.
    [32] - All randomized participants who received at least 1 dose of study treatment and had evaluable data.
    [33] - All randomized participants who received at least 1 dose of study treatment and had evaluable data.
    No statistical analyses for this end point

    Secondary: Percentage Change from Baseline in Total Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels

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    End point title
    		 Percentage Change from Baseline in Total Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels
    End point description
    LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable. The mITT is defined as all participants in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Q4W 20 mg LY3015014 Q4W 120 mg LY3015014 Q4W 300 mg LY3015014 Q4W 100 mg LY3015014 Q8W 300 mg LY3015014 Q8W
    Number of subjects analysed
    77 [34]
    76 [35]
    79 [36]
    79 [37]
    75 [38]
    75 [39]
    Units: Percentage change
        least squares mean (standard error)
    14.6 ( 13.66 )
    9.1 ( 14 )
    86.4 ( 13.65 )
    130.6 ( 13.63 )
    21.8 ( 13.63 )
    41 ( 13.63 )
    Notes
    [34] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [35] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [36] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [37] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [38] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [39] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    No statistical analyses for this end point

    Secondary: Percentage Change from Baseline in Free Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels

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    End point title
    		 Percentage Change from Baseline in Free Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels
    End point description
    LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable. The mITT is defined as all participants in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Q4W 20 mg LY3015014 Q4W 120 mg LY3015014 Q4W 300 mg LY3015014 Q4W 100 mg LY3015014 Q8W 300 mg LY3015014 Q8W
    Number of subjects analysed
    77 [40]
    72 [41]
    76 [42]
    75 [43]
    70 [44]
    72 [45]
    Units: Percentage change
        least squares mean (standard error)
    9.9 ( 5.59 )
    -16.3 ( 5.81 )
    -36.6 ( 5.67 )
    -68 ( 5.71 )
    -4.4 ( 5.8 )
    -35.2 ( 5.72 )
    Notes
    [40] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [41] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [42] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [43] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [44] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    [45] - mITT population who had at least 1 baseline measurement and 1 post-randomization measurement.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady-State (AUC,ss) for LY3015014

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    End point title
    		 Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady-State (AUC,ss) for LY3015014 [46]
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12-16 (Q4W), Week 8-16 (Q8W)
    Notes
    [46] - 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 treatment arm randomized to placebo will not have pharmacokinetic data available, so summary statistics will not be reported.
    End point values
    		 20 mg LY3015014 Q4W 120 mg LY3015014 Q4W 300 mg LY3015014 Q4W 100 mg LY3015014 Q8W 300 mg LY3015014 Q8W
    Number of subjects analysed
    83 [47]
    85 [48]
    82 [49]
    84 [50]
    86 [51]
    Units: μg∙hr/mL
        geometric mean (geometric coefficient of variation)
    1590 ( 29.2 )
    9670 ( 29.9 )
    27300 ( 26.3 )
    7800 ( 28.5 )
    26600 ( 32.2 )
    Notes
    [47] - All randomly assigned participants who received at least 1 dose of study drug & had evaluable data.
    [48] - All randomly assigned participants who received at least 1 dose of study drug & had evaluable data.
    [49] - All randomly assigned participants who received at least 1 dose of study drug & had evaluable data.
    [50] - All randomly assigned participants who received at least 1 dose of study drug & had evaluable data.
    [51] - All randomly assigned participants who received at least 1 dose of study drug & had evaluable data.
    No statistical analyses for this end point

    Secondary: Number of Participants with an Injection Site Reaction

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    End point title
    		 Number of Participants with an Injection Site Reaction
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline through Week 24
    End point values
    		 Placebo Q4W 20 mg LY3015014 Q4W 120 mg LY3015014 Q4W 300 mg LY3015014 Q4W 100 mg LY3015014 Q8W 300 mg LY3015014 Q8W
    Number of subjects analysed
    87
    87
    86
    86
    86
    87
    Units: Participants
        number (not applicable)
    13
    21
    28
    25
    18
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    I5S-MC-EFJE
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    LY3015014-20mg-Q4W
    Reporting group description
    		 -

    Reporting group title
    LY3015014-120mg-Q4W
    Reporting group description
    		 -

    Reporting group title
    LY3015014-300mg-Q4W
    Reporting group description
    		 -

    Reporting group title
    LY3015014-100mg-Q8W
    Reporting group description
    		 -

    Reporting group title
    LY3015014-300mg-Q8W
    Reporting group description
    		 -

    Reporting group title
    PLACEBO-Q4W
    Reporting group description
    		 -

    Serious adverse events
    		 LY3015014-20mg-Q4W LY3015014-120mg-Q4W LY3015014-300mg-Q4W LY3015014-100mg-Q8W LY3015014-300mg-Q8W PLACEBO-Q4W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 87 (3.45%)
    6 / 86 (6.98%)
    2 / 86 (2.33%)
    2 / 86 (2.33%)
    4 / 87 (4.60%)
    5 / 87 (5.75%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    laryngeal cancer
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 87 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    meningeal neoplasm
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
    0 / 87 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    prostate cancer
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed [1]
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 50 (0.00%)
    1 / 44 (2.27%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal cell carcinoma
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 87 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    squamous cell carcinoma
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 87 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    fall
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 87 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    femur fracture
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 87 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    deep vein thrombosis
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 87 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    atrial fibrillation
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 87 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atrial flutter
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 87 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    coronary artery stenosis
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 87 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
    0 / 87 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    loss of consciousness
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 87 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    paraesthesia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 87 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    subarachnoid haemorrhage
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    1 / 87 (1.15%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    pregnancy
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed [2]
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 36 (0.00%)
    0 / 43 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    chest pain
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    1 / 87 (1.15%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    dysphagia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
    0 / 87 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    mechanical ileus
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 87 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    calculus ureteric
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
    0 / 87 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 87 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteoarthritis
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    1 / 87 (1.15%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    lobar pneumonia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 87 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 87 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LY3015014-20mg-Q4W LY3015014-120mg-Q4W LY3015014-300mg-Q4W LY3015014-100mg-Q8W LY3015014-300mg-Q8W PLACEBO-Q4W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    69 / 87 (79.31%)
    64 / 86 (74.42%)
    64 / 86 (74.42%)
    64 / 86 (74.42%)
    58 / 87 (66.67%)
    63 / 87 (72.41%)
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    3 / 87 (3.45%)
    3 / 86 (3.49%)
    0 / 86 (0.00%)
    5 / 86 (5.81%)
    6 / 87 (6.90%)
    0 / 87 (0.00%)
         occurrences all number
    3
    3
    0
    5
    6
    0
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    6 / 87 (6.90%)
    11 / 86 (12.79%)
    8 / 86 (9.30%)
    8 / 86 (9.30%)
    2 / 87 (2.30%)
    6 / 87 (6.90%)
         occurrences all number
    7
    13
    11
    8
    8
    7
    General disorders and administration site conditions
    influenza like illness
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    2 / 87 (2.30%)
    1 / 86 (1.16%)
    1 / 86 (1.16%)
    1 / 86 (1.16%)
    1 / 87 (1.15%)
    6 / 87 (6.90%)
         occurrences all number
    2
    1
    1
    2
    1
    8
    injection site bruising
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 87 (1.15%)
    8 / 86 (9.30%)
    2 / 86 (2.33%)
    2 / 86 (2.33%)
    4 / 87 (4.60%)
    4 / 87 (4.60%)
         occurrences all number
    1
    9
    2
    3
    4
    4
    injection site erythema
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 87 (1.15%)
    9 / 86 (10.47%)
    7 / 86 (8.14%)
    2 / 86 (2.33%)
    3 / 87 (3.45%)
    0 / 87 (0.00%)
         occurrences all number
    1
    10
    10
    3
    3
    0
    injection site pain
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    15 / 87 (17.24%)
    11 / 86 (12.79%)
    8 / 86 (9.30%)
    7 / 86 (8.14%)
    9 / 87 (10.34%)
    3 / 87 (3.45%)
         occurrences all number
    20
    17
    17
    13
    12
    6
    injection site pruritus
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    4 / 87 (4.60%)
    6 / 86 (6.98%)
    8 / 86 (9.30%)
    2 / 86 (2.33%)
    2 / 87 (2.30%)
    1 / 87 (1.15%)
         occurrences all number
    6
    6
    13
    2
    3
    1
    injection site reaction
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 87 (1.15%)
    5 / 86 (5.81%)
    6 / 86 (6.98%)
    3 / 86 (3.49%)
    2 / 87 (2.30%)
    0 / 87 (0.00%)
         occurrences all number
    1
    7
    10
    4
    2
    0
    Gastrointestinal disorders
    diarrhoea
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    6 / 87 (6.90%)
    6 / 86 (6.98%)
    3 / 86 (3.49%)
    3 / 86 (3.49%)
    1 / 87 (1.15%)
    2 / 87 (2.30%)
         occurrences all number
    9
    6
    3
    4
    1
    3
    nausea
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    6 / 86 (6.98%)
    3 / 86 (3.49%)
    3 / 86 (3.49%)
    1 / 87 (1.15%)
    4 / 87 (4.60%)
         occurrences all number
    0
    6
    3
    3
    1
    4
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    3 / 87 (3.45%)
    5 / 86 (5.81%)
    2 / 86 (2.33%)
    1 / 86 (1.16%)
    1 / 87 (1.15%)
    5 / 87 (5.75%)
         occurrences all number
    3
    6
    2
    2
    1
    5
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    3 / 87 (3.45%)
    3 / 86 (3.49%)
    6 / 86 (6.98%)
    2 / 86 (2.33%)
    4 / 87 (4.60%)
    5 / 87 (5.75%)
         occurrences all number
    3
    3
    6
    2
    5
    5
    back pain
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    4 / 87 (4.60%)
    9 / 86 (10.47%)
    3 / 86 (3.49%)
    2 / 86 (2.33%)
    2 / 87 (2.30%)
    3 / 87 (3.45%)
         occurrences all number
    6
    10
    3
    2
    2
    3
    myalgia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    6 / 87 (6.90%)
    6 / 86 (6.98%)
    7 / 86 (8.14%)
    3 / 86 (3.49%)
    6 / 87 (6.90%)
    3 / 87 (3.45%)
         occurrences all number
    9
    8
    9
    5
    6
    3
    Infections and infestations
    bronchitis
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 86 (2.33%)
    3 / 86 (3.49%)
    2 / 86 (2.33%)
    3 / 87 (3.45%)
    5 / 87 (5.75%)
         occurrences all number
    0
    2
    3
    3
    3
    6
    influenza
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    5 / 87 (5.75%)
    2 / 86 (2.33%)
    3 / 86 (3.49%)
    2 / 86 (2.33%)
    1 / 87 (1.15%)
    3 / 87 (3.45%)
         occurrences all number
    5
    3
    3
    2
    2
    3
    nasopharyngitis
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    20 / 87 (22.99%)
    22 / 86 (25.58%)
    14 / 86 (16.28%)
    11 / 86 (12.79%)
    15 / 87 (17.24%)
    15 / 87 (17.24%)
         occurrences all number
    23
    22
    18
    13
    18
    17
    upper respiratory tract infection
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 87 (1.15%)
    5 / 86 (5.81%)
    7 / 86 (8.14%)
    6 / 86 (6.98%)
    5 / 87 (5.75%)
    4 / 87 (4.60%)
         occurrences all number
    2
    5
    8
    7
    5
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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