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    Clinical Trial Results:
    A 52 WEEK, PHASE 3 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF PF-04950615 IN SUBJECTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA

    Summary
    EudraCT number
    		 2013-002644-87
    Trial protocol
    		 FI   GB   NL   NO   ES   IT   BG  
    Global end of trial date
    15 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Apr 2017
    First version publication date
    23 Apr 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B1481021
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01968980
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800­718­1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800­718­1021, ClinicalTrials.gov_Inquiries@pfizer.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
    08 Feb 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate a superior Low density lipoprotein cholesterol (LDL-C) lowering effect of PF-04950615 150 milligram (mg) administered by the subcutaneous (SC) route every two weeks (Q2wks) compared to placebo, in subjects with heterozygous familial hypercholesterolemia (HeFH) and at high and very high risk of cardiovascular (CV) events receiving a maximally tolerated dose of statin therapy and whose LDL-C is >= 70 milligram per deciliter (mg/dL) (1.81 millimole per liter [mmol/L]).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Oct 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
    Bulgaria: 23
    Country: Number of subjects enrolled
    Canada: 57
    Country: Number of subjects enrolled
    Finland: 27
    Country: Number of subjects enrolled
    Italy: 28
    Country: Number of subjects enrolled
    Netherlands: 46
    Country: Number of subjects enrolled
    Norway: 23
    Country: Number of subjects enrolled
    Poland: 13
    Country: Number of subjects enrolled
    South Africa: 47
    Country: Number of subjects enrolled
    Spain: 40
    Country: Number of subjects enrolled
    United Kingdom: 23
    Country: Number of subjects enrolled
    United States: 43
    Worldwide total number of subjects
    370
    EEA total number of subjects
    223
    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)
    292
    From 65 to 84 years
    78
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The subjects for the study were enrolled from 11 countries. The study start date was 23-Oct-2013 and the study completion date was 15-Apr-2016.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.
    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
    Subjects received placebo matched to PF-04950615 once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

    Arm title
    		 PF-­04950615
    Arm description
    		 Subjects received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks.Subjects were followed up to 58 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-04950615
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received PF-04950615 150 milligram (mg) once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

    Number of subjects in period 1
    		Placebo PF-­04950615
    Started
    185
    185
    Completed
    169
    171
    Not completed
    16
    14
         Consent withdrawn by subject
    13
    5
         Adverse Event
    1
    3
         Other unspecified
    1
    2
         Death
    -
    1
         Does not meet entry criteria
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

    Reporting group title
    PF-­04950615
    Reporting group description
    		 Subjects received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks.Subjects were followed up to 58 weeks.

    Reporting group values
    		 Placebo PF-­04950615 Total
    Number of subjects
    		 185 185 370
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 147 145 292
        From 65-84 years
    		 38 40 78
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.7 ( 11.2 ) 56.5 ( 10.5 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 82 73 155
        Male
    		 103 112 215

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

    Reporting group title
    PF-­04950615
    Reporting group description
    		 Subjects received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks.Subjects were followed up to 58 weeks.

    Primary: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

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    End point title
    		 Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
    End point description
    Full analysis set (FAS) included all subjects who were randomized. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    175
    166
    Units: percent change
        arithmetic mean (standard deviation)
    -0.3 ( 18.3 )
    -54.2 ( 29.34 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    LS-mean difference, associated 95 percent (%) confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    341
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Mixed Model Repeated Measures (MMRM)
    Parameter type
    		 Least square (LS) mean difference
    Point estimate
    -54.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -59.5
         upper limit
    		 -49.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.54

    Secondary: Percent Change From Baseline in Total Cholesterol (TC) at Week 12

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    End point title
    		 Percent Change From Baseline in Total Cholesterol (TC) at Week 12
    End point description
    FAS included all subjects who were randomized. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    175
    166
    Units: percent change
        arithmetic mean (standard deviation)
    0 ( 14.45 )
    -37 ( 19.82 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    341
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    -37.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -41.1
         upper limit
    		 -34.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.77

    Secondary: Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12

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    End point title
    		 Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
    End point description
    FAS included all subjects who were randomized. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    175
    166
    Units: percent change
        arithmetic mean (standard deviation)
    0.4 ( 17.89 )
    -49.9 ( 26.8 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    341
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    -51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -55.7
         upper limit
    		 -46.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.36

    Secondary: Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12

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    End point title
    		 Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12
    End point description
    FAS included all subjects who were randomized. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    175
    166
    Units: percent change
        arithmetic mean (standard deviation)
    0.4 ( 15.96 )
    -47.5 ( 28.89 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    341
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    -48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -52.8
         upper limit
    		 -43.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.44

    Secondary: Percent Change From Baseline in Lipoprotein (a) at Week 12

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    End point title
    		 Percent Change From Baseline in Lipoprotein (a) at Week 12
    End point description
    FAS included all subjects who were randomized. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    172
    166
    Units: percent change
        arithmetic mean (standard deviation)
    2.2 ( 27.21 )
    -26.4 ( 23.63 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    338
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    -28.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -33.9
         upper limit
    		 -23.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.73

    Secondary: Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12

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    End point title
    		 Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
    End point description
    FAS included all subjects who were randomized. Here, "number of subjects analyzed" signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    175
    166
    Units: percent change
        arithmetic mean (standard deviation)
    -0.3 ( 12.99 )
    6.3 ( 15.11 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    341
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.1
         upper limit
    		 9.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.47

    Secondary: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52

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    End point title
    		 Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, 52
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: percent change
    arithmetic mean (standard deviation)
        Week 24 (n =175, 173)
    2.7 ( 25.38 )
    -50.1 ( 32.94 )
        Week 52 (n =169, 171)
    3.5 ( 21.49 )
    -45.3 ( 30.87 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 24: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS mean difference
    Point estimate
    -52.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -58.2
         upper limit
    		 -46
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.1
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Week 52: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS mean difference
    Point estimate
    -48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -53.6
         upper limit
    		 -42.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.87

    Secondary: Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52

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    End point title
    		 Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, 52
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: percent change
    arithmetic mean (standard deviation)
        Week 24 (n =176, 173)
    1.6 ( 19.1 )
    -34.4 ( 21.44 )
        Week 52 (n =169, 171)
    1.2 ( 15.82 )
    -31 ( 21.5 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 24: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -35.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -40
         upper limit
    		 -31.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.12
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Week 52: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -31.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -35.8
         upper limit
    		 -27.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.02

    Secondary: Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52

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    End point title
    		 Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, 52
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: percent change
    arithmetic mean (standard deviation)
        Week 24 (n =174, 173)
    2.4 ( 24.06 )
    -46.7 ( 29.88 )
        Week 52 (n =169, 171)
    1.2 ( 19.25 )
    -41.8 ( 29.99 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 24: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -48.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -54.1
         upper limit
    		 -42.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.86
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Week 52: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -42.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -47.5
         upper limit
    		 -36.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.71

    Secondary: Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52

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    End point title
    		 Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, 52
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: percent change
    arithmetic mean (standard deviation)
        Week 24 (n =176, 171)
    2.6 ( 19.29 )
    -44.8 ( 30.4 )
        Week 52 (n =169, 171)
    1.7 ( 16.45 )
    -39.3 ( 28.89 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 24: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -46.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -52.1
         upper limit
    		 -41.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.67
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Week 52: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -40.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -45.5
         upper limit
    		 -35.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.53

    Secondary: Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52

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    End point title
    		 Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, 52
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: percent change
    arithmetic mean (standard deviation)
        Week 24 (n =175, 172)
    14.6 ( 157.93 )
    -21.2 ( 48.77 )
        Week 52 (n =168, 171)
    1.3 ( 30.5 )
    -15.1 ( 68.22 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 24: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -35.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -59.8
         upper limit
    		 -10.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    12.58
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Week 52: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -15.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.3
         upper limit
    		 -4.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.58

    Secondary: Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52

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    End point title
    		 Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, 52
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: percent change
    arithmetic mean (standard deviation)
        Week 24 (n =174, 173)
    0.9 ( 14.19 )
    6.6 ( 12.85 )
        Week 52 (n =169, 171)
    2.2 ( 14.51 )
    4.7 ( 14.3 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 24: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    5.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.1
         upper limit
    		 8.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.42
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Week 52: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 5.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.53

    Secondary: Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52

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    End point title
    		 Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: percent change
    arithmetic mean (standard deviation)
        Week 12 (n =175, 166)
    7.1 ( 41.23 )
    -8.7 ( 38.07 )
        Week 24 (n =176, 173)
    7.6 ( 51.97 )
    -9 ( 40.01 )
        Week 52 (n =169, 171)
    4.9 ( 33.03 )
    -3.4 ( 58.27 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 12: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.3
         upper limit
    		 -8.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.22
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Week 24: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -17.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27
         upper limit
    		 -7.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.9
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Week 52: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -9.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.4
         upper limit
    		 0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.04

    Secondary: Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52

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    End point title
    		 Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: percent change
    arithmetic mean (standard deviation)
        Week 12 (n =175, 166)
    -0.5 ( 11.7 )
    4.8 ( 12.15 )
        Week 24 (n =176, 172)
    -0.6 ( 10.69 )
    3.9 ( 10.72 )
        Week 52 (n =169, 171)
    0.3 ( 12.02 )
    3 ( 11.53 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 12: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.9
         upper limit
    		 7.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.25
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Week 24: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    4.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.5
         upper limit
    		 6.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.1
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Week 52: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 5.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.22

    Secondary: Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52

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    End point title
    		 Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: percent change
    arithmetic mean (standard deviation)
        Week 12 (n =175, 166)
    -2.6 ( 13.34 )
    -1.6 ( 15.68 )
        Week 24 (n =175, 170)
    -2.8 ( 11.88 )
    -1.8 ( 13.45 )
        Week 52 (n =167, 171)
    -3.5 ( 11.9 )
    -2.4 ( 14.5 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 12: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 3.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.5
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Week 52: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 3.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.39
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Week 24: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 3.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.31

    Secondary: Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52

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    End point title
    		 Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: percent change
    arithmetic mean (standard deviation)
        Week 12 (n =175, 166)
    7.1 ( 41.23 )
    -8.7 ( 38.07 )
        Week 24 (n =176, 173)
    7.6 ( 51.97 )
    -9 ( 40.01 )
        Week 52 (n =169, 171)
    4.9 ( 33.03 )
    -3.4 ( 58.27 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 12: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.3
         upper limit
    		 -8.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.22
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Week 52: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -9.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.4
         upper limit
    		 0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.04
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Week 24: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -17.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27
         upper limit
    		 -7.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.9

    Secondary: Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12

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    End point title
    		 Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: milligram per deciliter (mg/dL)
    arithmetic mean (standard deviation)
        Baseline (n= 185, 185)
    150 ( 59.75 )
    144.2 ( 41.96 )
        Change at Week 12 (n= 175, 176)
    -3 ( 30.47 )
    -79.1 ( 46.97 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -78.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -86.2
         upper limit
    		 -71.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.75

    Secondary: Absolute Change From Baseline in Total Cholesterol (TC) at Week 12

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    End point title
    		 Absolute Change From Baseline in Total Cholesterol (TC) at Week 12
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n= 185, 185)
    227.2 ( 67.31 )
    220.7 ( 46.26 )
        Change at Week 12 (n= 175, 166)
    -2.8 ( 36.43 )
    -83.2 ( 49.51 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -83.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -91.3
         upper limit
    		 -75
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.15

    Secondary: Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12

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    End point title
    		 Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n= 185, 185)
    178.6 ( 66.64 )
    170.4 ( 45.12 )
        Change at Week 12 (n= 175, 166)
    -2.3 ( 36.24 )
    -86 ( 51.09 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -95.4
         upper limit
    		 -78.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.25

    Secondary: Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12

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    End point title
    		 Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n= 185, 185)
    115.9 ( 35.25 )
    112.8 ( 26.26 )
        Change at Week 12 (n= 175, 166)
    -0.9 ( 20.51 )
    -53.7 ( 33.07 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -53.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -59.2
         upper limit
    		 -48.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.71

    Secondary: Absolute Change From Baseline in Lipoprotein (a) at Week 12

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    End point title
    		 Absolute Change From Baseline in Lipoprotein (a) at Week 12
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n= 184, 185)
    58.8 ( 69.88 )
    59.7 ( 63.38 )
        Change at Week 12 (n= 172, 166)
    -1.4 ( 14.02 )
    -14 ( 17.91 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -11.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.7
         upper limit
    		 -8.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.47

    Secondary: Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12

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    End point title
    		 Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n= 185, 185)
    48.6 ( 11.84 )
    50.3 ( 11.4 )
        Change at Week 12 (n= 175, 166)
    -0.6 ( 6.31 )
    2.8 ( 7.89 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2
         upper limit
    		 4.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.75

    Secondary: Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52

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    End point title
    		 Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: ratio
    arithmetic mean (standard deviation)
        Baseline (n =185, 185)
    4.9 ( 1.81 )
    4.6 ( 1.32 )
        Change at Week 12 (n =175, 166)
    0 ( 1 )
    -1.8 ( 1.29 )
        Change at Week 24 (n =174, 173)
    0 ( 1.2 )
    -1.7 ( 1.29 )
        Change at Week 52 (n =169, 171)
    0 ( 1 )
    -1.5 ( 1.35 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 12: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 -1.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Week 24: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 -1.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Week 52: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 -1.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12

    Secondary: Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52

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    End point title
    		 Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: ratio
    arithmetic mean (standard deviation)
        Baseline (n =185, 185)
    0.8 ( 0.31 )
    0.8 ( 0.23 )
        Change at Week 12 (n =175, 166)
    0 ( 0.18 )
    -0.4 ( 0.25 )
        Change at Week 24 (n =176, 171)
    0 ( 0.17 )
    -0.4 ( 0.25 )
        Change at Week 52 (n =169, 171)
    0 ( 0.17 )
    -0.3 ( 0.25 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 12: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 -0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.02
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Week 24: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 -0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.02
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Week 52: LS-mean difference, associated 95% confidence intervals (CI) were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 -0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.02

    Secondary: Percentage of Subjects Achieving Low Density Lipoprotein-Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram per Deciliter (2.59 Millimoles per Liter) at Week 12, 24 and 52

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    End point title
    		 Percentage of Subjects Achieving Low Density Lipoprotein-Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram per Deciliter (2.59 Millimoles per Liter) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Week 12, 24, 52
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: percentage of subjects
    number (not applicable)
        Week 12 (n =175, 166)
    13.1
    83.1
        Week 24 (n =175, 173)
    13.1
    80.9
        Week 52 (n =169, 171)
    16.6
    70.8
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 12: Odds ratio, associated 95% confidence interval from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    51.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 25.24
         upper limit
    		 106.1
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Week 24: Odds ratio, associated 95% confidence interval from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    66.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 30.32
         upper limit
    		 147.43
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Week 52: Odds ratio, associated 95% confidence interval from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    22.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.85
         upper limit
    		 44.01

    Secondary: Percentage of Subjects Achieving Low Density Lipoprotein-Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram per Deciliter (1.81 Millimoles per Liter) at Week 12, 24 and 52

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    End point title
    		 Percentage of Subjects Achieving Low Density Lipoprotein-Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram per Deciliter (1.81 Millimoles per Liter) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Week 12, 24, 52
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: percentage of subjects
    number (not applicable)
        Week 12 (n =175, 166)
    1.1
    66.3
        Week 24 (n =175, 173)
    1.1
    60.7
        Week 52 (n =169, 171)
    0.6
    53.2
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 12: Odds ratio, associated 95% confidence interval from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    200.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 47.16
         upper limit
    		 854.6
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Week 52: Odds ratio, associated 95% confidence interval from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    259.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 34.87
         upper limit
    		 1937.06
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Week 24: Odds ratio, associated 95% confidence interval from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.
    Comparison groups
    Placebo v PF-­04950615
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    228
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 51.95
         upper limit
    		 1000.39

    Secondary: Plasma PF-04950615 Concentrations at Week 12, 24 and 52

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    End point title
    		 Plasma PF-04950615 Concentrations at Week 12, 24 and 52 [1]
    End point description
    Analysis was performed on all subjects who received at least 1 dose of PF-04950615. Here, ‘n’ signifies those subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Week 12, 24, 52
    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: No statistical analysis was planned for this endpoint
    End point values
    		 PF-­04950615
    Number of subjects analysed
    185
    Units: microgram per milliliter
    arithmetic mean (standard deviation)
        Week 12 (n =163)
    6.23 ( 5.657 )
        Week 24 (n =167)
    7 ( 6.351 )
        Week 52 (n =171)
    4.84 ( 5.384 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions

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    End point title
    		 Number of Subjects With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions
    End point description
    Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reaction is a reaction at the site of the subcutaneous injection and characterized by the symptoms of erythema, swelling, tenderness and warmth. Subjects with any of the above type 1 or type 3 hypersensitivity reactions and subjects with any of the above injection site reactions were reported in this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to the end of study (up to 58 weeks)
    End point values
    		 Placebo PF-­04950615
    Number of subjects analysed
    185
    185
    Units: subjects
        With Type 1 or 3 hypersensitivity reactions
    0
    0
        With Injection site reactions
    1
    38
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Positive Anti­drug Antibodies (ADA) and Neutralizing Antibodies (nAb)

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    End point title
    		 Percentage of Subjects With Positive Anti­drug Antibodies (ADA) and Neutralizing Antibodies (nAb) [2]
    End point description
    Percentage of subjects with at least 1 positive ADA titer or 1 positive nAb titer were reported in this endpoint. ADA titer greater than or equal to (>=) 6.23 were considered as ADA positive and nAb titer level >=1.58 were considered as nAb positive. Analysis was performed on all subjects who received at least 1 dose of PF-04950615.
    End point type
    Secondary
    End point timeframe
    Baseline up to the end of study (up to 58 weeks)
    Notes
    [2] - 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: No statistical analysis was planned for this endpoint
    End point values
    		 PF-­04950615
    Number of subjects analysed
    185
    Units: percentage of subjects
    number (not applicable)
        With positive ADA
    49.7
        With positive nAb
    33
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to the end of study (up to 58 weeks)
    Adverse event reporting additional description
    The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non serious in another subject, or one subject may have experienced both a serious and non serious event during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    PF­-04950615
    Reporting group description
    		 Subjects received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

    Serious adverse events
    		 PF­-04950615 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 185 (12.97%)
    22 / 185 (11.89%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Appendix cancer
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian neoplasm
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral ischaemia
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular stent restenosis
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
    Additional description: This is gender specific event. The number of participants evaluable for this event are 103 and 112.
         subjects affected / exposed [1]
    1 / 112 (0.89%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device breakage
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative ileus
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    2 / 185 (1.08%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 185 (0.54%)
    3 / 185 (1.62%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 185 (0.54%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    2 / 185 (1.08%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinal artery occlusion
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus bladder
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound sepsis
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Obesity
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    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 is gender specific event. The number of participants evaluable for this event are 103 and 112.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PF­-04950615 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    70 / 185 (37.84%)
    36 / 185 (19.46%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 185 (5.41%)
    10 / 185 (5.41%)
         occurrences all number
    17
    12
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    38 / 185 (20.54%)
    1 / 185 (0.54%)
         occurrences all number
    159
    2
    Infections and infestations
    Influenza
         subjects affected / exposed
    10 / 185 (5.41%)
    6 / 185 (3.24%)
         occurrences all number
    11
    6
    Nasopharyngitis
         subjects affected / exposed
    15 / 185 (8.11%)
    15 / 185 (8.11%)
         occurrences all number
    20
    15
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 185 (5.95%)
    7 / 185 (3.78%)
         occurrences all number
    14
    9

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jul 2014
    1. It was clarified that known history of cardiovascular disease (CVD) included any one of the examples of previous medical history, allowed inclusion of HeFH subjects with LDL-C ≥100 mg/dL at the highest approved dose of statin or ≥110 mg/dL not at the highest dose of statin without cardiovascular disease or risk equivalents. 2. Allowance for repeat LDL-C at the second screening visit if greater than 20% variance from initial visit was added. 3. The window for injection to 1 day before and 4 days after the scheduled date of injection was updated. 4. Injection sites to include upper abdominal quadrants were modified. 5. Follow up period for SAEs was updated to 40 days after last dose of study. 6. Protocol specified adverse events were removed. 7. There was a minor revision of adverse event reporting section of protocol in line with new Pfizer protocol template language.

    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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