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Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events (SPIRE-HR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01968954
Recruitment Status : Completed
First Posted : October 24, 2013
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hyperlipidemia
Interventions Drug: Bococizumab (PF-04950615;RN316)
Other: Placebo
Enrollment 711
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks. Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Period Title: Overall Study
Started 354 357
Treated 353 356
Completed 314 314
Not Completed 40 43
Reason Not Completed
Adverse Event             6             3
Death             1             2
Lost to Follow-up             6             4
Withdrawal by Subject             20             23
Other             7             8
Protocol Violation             0             1
Did not met inclusion criteria             0             2
Arm/Group Title Placebo PF-04950615 150 mg Total
Hide Arm/Group Description Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks. Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks. Total of all reporting groups
Overall Number of Baseline Participants 354 357 711
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all participants who were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 354 participants 357 participants 711 participants
61.5  (9.7) 61.1  (10.2) 61.3  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 354 participants 357 participants 711 participants
Female
130
  36.7%
136
  38.1%
266
  37.4%
Male
224
  63.3%
221
  61.9%
445
  62.6%
1.Primary Outcome
Title Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12
Hide Description [Not Specified]
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 329 336
Mean (Standard Deviation)
Unit of Measure: percent change
1.0  (20.89) -55.6  (29.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Model Repeated Measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square (LS) Mean Difference
Estimated Value -57.0
Confidence Interval (2-Sided) 95%
-61.0 to -53.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.00
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: percent change
Week 12 (n =330, 340) 1.0  (14.85) -35.1  (19.23)
Week 24 (n =331, 337) 3.2  (19.35) -31.7  (20.47)
Week 52 (n =313, 315) 1.8  (18.50) -27.3  (23.57)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -36.2
Confidence Interval (2-Sided) 95%
-38.8 to -33.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -34.7
Confidence Interval (2-Sided) 95%
-37.7 to -31.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -29.0
Confidence Interval (2-Sided) 95%
-32.3 to -25.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.69
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: percent change
Week 12 (n =330, 339) 1.3  (19.53) -50.0  (26.28)
Week 24 (n =329, 336) 4.7  (27.81) -46.2  (28.52)
Week 52 (n =312, 314) 2.3  (25.22) -38.9  (33.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -51.6
Confidence Interval (2-Sided) 95%
-55.2 to -48.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean Difference
Estimated Value -50.6
Confidence Interval (2-Sided) 95%
-54.9 to -46.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 52:LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -41.2
Confidence Interval (2-Sided) 95%
-45.8 to -36.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.38
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: percent change
Week 12 (n =330, 339) 0.3  (19.10) -51.1  (27.62)
Week 24 (n =331, 335) 3.5  (22.39) -47.3  (30.43)
Week 52 (n =313, 313) 1.9  (22.25) -39.1  (33.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -51.5
Confidence Interval (2-Sided) 95%
-55.1 to -47.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -50.6
Confidence Interval (2-Sided) 95%
-54.6 to -46.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -40.8
Confidence Interval (2-Sided) 95%
-45.2 to -36.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.26
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: percent change
Week 12 (n =330, 339) 4.7  (84.86) 1.9  (508.44)
Week 24 (n =331, 336) 1.9  (51.82) 4.4  (465.24)
Week 52 (n =311, 311) 1.1  (42.47) 17.3  (562.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.860
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.9
Confidence Interval (2-Sided) 95%
-35.4 to 29.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 16.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
-47.2 to 51.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 25.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 12.9
Confidence Interval (2-Sided) 95%
-44.5 to 70.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 29.25
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: percent change
Week 12 (n= 330, 339) 1.9  (17.24) 6.6  (14.24)
Week 24 (n =329, 336) 1.0  (15.78) 7.8  (15.91)
Week 52 (n =312, 314) 2.0  (15.73) 5.3  (16.59)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.7
Confidence Interval (2-Sided) 95%
2.4 to 7.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 6.8
Confidence Interval (2-Sided) 95%
4.5 to 9.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.3
Confidence Interval (2-Sided) 95%
0.9 to 5.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.25
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Primary Hyperlipidemia
Hide Description Participants with primary hyperlipidemia are defined as participants with triglycerides (TG) level less than (<) 200 milligram per decilitre (mg/dL) (2.26 millimoles per litre [mmol/L]) at pre-randomization.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 262 266
Mean (Standard Deviation)
Unit of Measure: percent change
1.5  (20.89) -56.8  (27.78)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -59.1
Confidence Interval (2-Sided) 95%
-63.4 to -54.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.19
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia
Hide Description Participants with mixed dyslipidemia are defined as TG level greater than or equal to (>=) 200 mg/dL (2.26 mmol/L) at pre-randomization.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 67 70
Mean (Standard Deviation)
Unit of Measure: percent change
-1.0  (20.95) -50.9  (33.78)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -48.7
Confidence Interval (2-Sided) 95%
-58.0 to -39.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.72
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: percent change
Week 24 (n =331, 336) 6.3  (32.52) -50.0  (31.36)
Week 52 (n =311, 313) 5.2  (29.69) -40.9  (38.02)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -56.0
Confidence Interval (2-Sided) 95%
-60.8 to -51.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -46.4
Confidence Interval (2-Sided) 95%
-51.8 to -41.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.77
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off
Hide Description Percent change from baseline in fasting LDL-C among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.
Time Frame Baseline, Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: percent change
TG <200 mg/dL: Week 24 (n =261, 265) 7.2  (34.38) -50.8  (30.90)
TG <200 mg/dL: Week 52(n =243, 248) 6.2  (29.95) -41.1  (38.35)
TG >=200 mg/dL: Week 24(n =70, 71) 3.0  (24.30) -46.9  (33.05)
TG >=200 mg/dL: Week 52(n =68, 65) 2.0  (28.74) -40.1  (37.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments TG <200 mg/dL (Week 24): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -57.6
Confidence Interval (2-Sided) 95%
-63.1 to -52.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments TG <200 mg/dL (Week 52): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -47.7
Confidence Interval (2-Sided) 95%
-53.9 to -41.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments TG >=200 mg/dL (Week 24): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -49.3
Confidence Interval (2-Sided) 95%
-58.9 to -39.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments TG >=200 mg/dL (Week 52): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -41.2
Confidence Interval (2-Sided) 95%
-52.2 to -30.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.60
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: percent change
Week 12 (n =330, 340) 5.9  (34.90) -9.4  (42.00)
Week 24 (n =331, 336) 7.0  (37.79) -13.8  (33.24)
Week 52 (n =313, 315) 0.6  (38.33) -9.3  (48.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -14.2
Confidence Interval (2-Sided) 95%
-19.9 to -8.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -19.9
Confidence Interval (2-Sided) 95%
-25.1 to -14.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -9.2
Confidence Interval (2-Sided) 95%
-15.7 to -2.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.31
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: percent change
Week 12 (n =330, 339) -0.3  (14.05) 3.7  (12.56)
Week 24 (n =331, 336) -0.8  (12.77) 4.3  (12.25)
Week 52 (n =313, 313) 0.4  (13.13) 3.3  (13.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.7
Confidence Interval (2-Sided) 95%
1.8 to 5.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.9
Confidence Interval (2-Sided) 95%
3.1 to 6.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
0.7 to 4.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.98
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: percent change
Week 12 (n =327, 339) -1.8  (12.92) -1.9  (12.10)
Week 24 (n =331, 335) -3.7  (14.40) -1.9  (13.25)
Week 52 (n =310, 310) -3.0  (14.76) -1.6  (12.91)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-1.9 to 1.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
-0.1 to 3.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-1.0 to 3.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.03
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: percent change
Week 12 (n =330, 340) 5.9  (34.90) -9.4  (42.00)
Week 24 (n =331, 336) 7.0  (37.79) -13.8  (33.24)
Week 52 (n =313, 315) 0.6  (38.33) -9.3  (48.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS-Mean Difference
Estimated Value -14.2
Confidence Interval (2-Sided) 95%
-19.9 to -8.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -19.9
Confidence Interval (2-Sided) 95%
-25.1 to -14.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -9.2
Confidence Interval (2-Sided) 95%
-15.7 to -2.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.31
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off
Hide Description Absolute change from baseline among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized.'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 353 357
Mean (Standard Deviation)
Unit of Measure: mg/dL
TG <200 mg/dL: Baseline (n =282, 282) 111.2  (31.28) 112.8  (36.42)
TG <200 mg/dL: Change at Week12 (n =262, 266) 0.4  (22.60) -63.4  (37.38)
TG >=200 mg/dL: Baseline (n =71, 75) 126.5  (42.07) 125.7  (42.10)
TG >=200 mg/dL: Change at Week 12 (n =67, 70) -2.6  (26.98) -63.1  (44.91)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments TG <200 mg/dL (Week 12): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -64.2
Confidence Interval (2-Sided) 95%
-69.1 to -59.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments TG >=200 mg/dL (Week 12): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -59.6
Confidence Interval (2-Sided) 95%
-71.4 to -47.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.99
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n =353, 357) 114.3  (34.22) 115.5  (37.99)
Change at Week 12 (n =329, 336) -0.2  (23.55) -63.3  (39.00)
Change at Week 24 (n =331, 336) 5.5  (33.14) -56.0  (39.34)
Change at Week 52 (n =311, 313) 3.9  (32.17) -45.9  (46.43)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -63.4
Confidence Interval (2-Sided) 95%
-68.0 to -58.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.35
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n =354, 357) 186.0  (40.04) 189.0  (44.68)
Change at Week 12 (n =330, 340) 0.6  (27.64) -66.8  (42.38)
Change at Week 24 (n =331, 337) 5.1  (35.83) -60.1  (43.33)
Change at Week 52 (n =313, 315) 1.8  (35.18) -51.9  (49.68)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -67.1
Confidence Interval (2-Sided) 95%
-72.2 to -62.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.59
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n =354, 357) 137.2  (37.38) 140.1  (43.48)
Change at Week 12 (n =330, 339) 0.3  (26.53) -69.8  (43.53)
Change at Week 24 (n =329, 336) 5.2  (35.91) -63.6  (44.37)
Change at Week 52 (n =312, 314) 1.3  (33.93) -53.9  (51.10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -69.7
Confidence Interval (2-Sided) 95%
-74.7 to -64.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.57
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n =354, 357) 94.0  (21.51) 95.1  (25.57)
Change at Week 12 (n =330, 339) -0.5  (17.32) -47.9  (28.40)
Change at Week 24 (n =331, 335) 2.5  (19.87) -43.9  (29.95)
Change at Week 52 (n =313, 313) 0.9  (20.59) -36.4  (32.23)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -47.3
Confidence Interval (2-Sided) 95%
-50.7 to -43.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.74
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n =353, 356) 44.0  (45.93) 45.1  (52.30)
Change at Week 12 (n =330, 339) -0.6  (10.42) -11.4  (22.19)
Change at Week 24 (n =331, 336) -1.2  (12.62) -10.6  (20.16)
Change at Week 52 (n =311, 311) -1.0  (10.71) -8.6  (23.78)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -10.6
Confidence Interval (2-Sided) 95%
-12.9 to -8.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.17
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n =354, 357) 48.7  (12.52) 49.0  (13.23)
Change at Week 12 (n =330, 339) 0.4  (7.50) 2.9  (6.92)
Change at Week 24 (n =329, 336) -0.0  (7.90) 3.3  (7.41)
Change at Week 52 (n =312, 314) 0.6  (7.59) 2.1  (8.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
1.4 to 3.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.55
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline (n =354, 357) 4.0  (1.10) 4.1  (1.26)
Change at Week 12 (n =330, 339) -0.0  (0.71) -1.6  (1.17)
Change at Week 24 (n =329, 336) 0.1  (0.93) -1.5  (1.21)
Change at Week 52 (n =312, 314) 0.0  (0.85) -1.2  (1.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-1.7 to -1.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-1.7 to -1.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-1.4 to -1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline (n =354, 357) 0.7  (0.18) 0.7  (0.21)
Change at Week 12 (n =330, 339) 0.0  (0.12) -0.3  (0.21)
Change at Week 24 (n =331, 335) 0.0  (0.16) -0.3  (0.24)
Change at Week 52 (n =313, 313) 0.0  (0.14) -0.3  (0.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.4 to -0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.4 to -0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.3 to -0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Litre) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Week 12, 24 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 (n =330, 336) 41.5 87.5
Week 24 (n =332, 336) 37.3 82.1
Week 52 (n =312, 313) 36.9 77.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 24.0
Confidence Interval (2-Sided) 95%
13.86 to 41.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 14.8
Confidence Interval (2-Sided) 95%
9.32 to 23.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 9.8
Confidence Interval (2-Sided) 95%
6.36 to 15.24
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Litre) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Week 12, 24 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 (n =330, 336) 5.5 76.8
Week 24 (n =332, 336) 3.3 69.6
Week 52 (n =312, 313) 6.4 61.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 95.2
Confidence Interval (2-Sided) 95%
52.09 to 173.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 112.2
Confidence Interval (2-Sided) 95%
55.81 to 225.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04950615 150 mg
Comments Week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 29.1
Confidence Interval (2-Sided) 95%
17.13 to 49.49
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Plasma PF-04950615 Concentrations at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set included participants who received at least 1 dose of PF-04950615. Here, 'n' signifies those participants who were evaluable at specified time points.
Arm/Group Title PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 356
Mean (Standard Deviation)
Unit of Measure: microgram per milliliter
Week 12 (n =332) 5.53  (5.666)
Week 24 (n =327) 5.36  (6.029)
Week 52 (n =306) 4.07  (4.947)
27.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions
Hide 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's, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, pain, pruritus and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.
Time Frame Baseline up to the end of study (up to 58 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study treatment.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 353 356
Measure Type: Number
Unit of Measure: participants
Type 1 or 3 hypersensitivity reactions 2 1
Injection site reactions 5 42
28.Secondary Outcome
Title Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
Hide Description Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. Participants with their ADA titer >=6.23 were considered to be ADA positive and participants with their nAb titer >=1.58 were considered to be nAb positive.
Time Frame Baseline up to the end of study (up to 58 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study treatment. Participants who received at least 1 dose of PF-04950615 were evaluable for this outcome measure. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 352
Measure Type: Number
Unit of Measure: percentage of participants
ADA 44
nAb 27
29.Other Pre-specified Outcome
Title Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n =354, 357) 149.5  (66.83) 156.2  (78.75)
Change at Week 12 (n =330, 340) 3.8  (57.04) -23.0  (71.52)
Change at Week 24 (n =331, 336) 5.0  (64.34) -28.9  (68.41)
Change at Week 52 (n =313, 315) -7.7  (64.14) -24.3  (82.21)
30.Other Pre-specified Outcome
Title Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n =354, 357) 147.5  (24.25) 147.2  (24.96)
Change at Week 12 (n =330, 339) -1.2  (19.46) 4.6  (18.32)
Change at Week 24 (n =331, 336) -2.3  (19.33) 5.6  (17.53)
Change at Week 52 (n =313, 313) -0.2  (19.56) 3.8  (18.86)
31.Other Pre-specified Outcome
Title Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description:
Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 354 357
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n =353, 356) 38.1  (6.46) 38.2  (6.58)
Change at Week 12 (n =327, 339) -0.9  (4.95) -0.9  (4.63)
Change at Week 24 (n =331, 335) -1.7  (5.65) -1.0  (5.07)
Change at Week 52 (n =310, 310) -1.5  (5.54) -0.9  (5.15)
Time Frame Baseline up to the end of study (up to 58 weeks)
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
 
Arm/Group Title Placebo PF-04950615 150 mg
Hide Arm/Group Description Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks. Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
All-Cause Mortality
Placebo PF-04950615 150 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo PF-04950615 150 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   40/353 (11.33%)   45/356 (12.64%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/353 (0.00%)  1/356 (0.28%) 
Normochromic normocytic anaemia * 1  1/353 (0.28%)  0/356 (0.00%) 
Cardiac disorders     
Acute coronary syndrome * 1  1/353 (0.28%)  0/356 (0.00%) 
Angina pectoris * 1  2/353 (0.57%)  0/356 (0.00%) 
Angina unstable * 1  1/353 (0.28%)  3/356 (0.84%) 
Atrial fibrillation * 1  0/353 (0.00%)  1/356 (0.28%) 
Bradycardia * 1  1/353 (0.28%)  1/356 (0.28%) 
Cardiac failure * 1  1/353 (0.28%)  0/356 (0.00%) 
Cardiac failure congestive * 1  2/353 (0.57%)  1/356 (0.28%) 
Coronary artery disease * 1  2/353 (0.57%)  2/356 (0.56%) 
Left ventricular failure * 1  0/353 (0.00%)  1/356 (0.28%) 
Myocardial infarction * 1  3/353 (0.85%)  5/356 (1.40%) 
Myocardial ischaemia * 1  1/353 (0.28%)  1/356 (0.28%) 
Silent myocardial infarction * 1  0/353 (0.00%)  1/356 (0.28%) 
Ventricular extrasystoles * 1  0/353 (0.00%)  1/356 (0.28%) 
Eye disorders     
Retinal aneurysm * 1  1/353 (0.28%)  0/356 (0.00%) 
Retinal haemorrhage * 1  1/353 (0.28%)  0/356 (0.00%) 
Gastrointestinal disorders     
Faecaloma * 1  0/353 (0.00%)  1/356 (0.28%) 
Gastritis * 1  1/353 (0.28%)  0/356 (0.00%) 
Inguinal hernia * 1  0/353 (0.00%)  1/356 (0.28%) 
Intestinal ischaemia * 1  1/353 (0.28%)  0/356 (0.00%) 
Large intestine polyp * 1  1/353 (0.28%)  0/356 (0.00%) 
Mesenteric artery stenosis * 1  1/353 (0.28%)  0/356 (0.00%) 
Pancreatitis acute * 1  0/353 (0.00%)  1/356 (0.28%) 
Small intestinal obstruction * 1  1/353 (0.28%)  0/356 (0.00%) 
General disorders     
Chest pain * 1  2/353 (0.57%)  4/356 (1.12%) 
Non-cardiac chest pain * 1  3/353 (0.85%)  2/356 (0.56%) 
Pyrexia * 1  0/353 (0.00%)  1/356 (0.28%) 
Infections and infestations     
Appendicitis * 1  1/353 (0.28%)  0/356 (0.00%) 
Appendicitis perforated * 1  1/353 (0.28%)  0/356 (0.00%) 
Arthritis bacterial * 1  1/353 (0.28%)  0/356 (0.00%) 
Bursitis infective * 1  1/353 (0.28%)  0/356 (0.00%) 
Cellulitis * 1  1/353 (0.28%)  2/356 (0.56%) 
Diverticulitis * 1  1/353 (0.28%)  0/356 (0.00%) 
Encephalitis * 1  1/353 (0.28%)  0/356 (0.00%) 
Endocarditis staphylococcal * 1  0/353 (0.00%)  1/356 (0.28%) 
Gastroenteritis * 1  1/353 (0.28%)  0/356 (0.00%) 
Gastroenteritis viral * 1  0/353 (0.00%)  1/356 (0.28%) 
Hepatitis B * 1  0/353 (0.00%)  1/356 (0.28%) 
Pneumonia * 1  1/353 (0.28%)  1/356 (0.28%) 
Sepsis * 1  1/353 (0.28%)  0/356 (0.00%) 
Staphylococcal bacteraemia * 1  0/353 (0.00%)  1/356 (0.28%) 
Urinary tract infection * 1  0/353 (0.00%)  1/356 (0.28%) 
Urosepsis * 1  0/353 (0.00%)  1/356 (0.28%) 
Injury, poisoning and procedural complications     
Craniocerebral injury * 1  0/353 (0.00%)  1/356 (0.28%) 
Fall * 1  0/353 (0.00%)  2/356 (0.56%) 
Femur fracture * 1  1/353 (0.28%)  0/356 (0.00%) 
Humerus fracture * 1  1/353 (0.28%)  1/356 (0.28%) 
Lumbar vertebral fracture * 1  1/353 (0.28%)  1/356 (0.28%) 
Patella fracture * 1  1/353 (0.28%)  0/356 (0.00%) 
Pelvic fracture * 1  0/353 (0.00%)  1/356 (0.28%) 
Subdural haematoma * 1  1/353 (0.28%)  1/356 (0.28%) 
Vascular graft complication * 1  1/353 (0.28%)  0/356 (0.00%) 
Wound * 1  0/353 (0.00%)  1/356 (0.28%) 
Metabolism and nutrition disorders     
Dehydration * 1  2/353 (0.57%)  0/356 (0.00%) 
Hypoglycaemia * 1  0/353 (0.00%)  1/356 (0.28%) 
Type 2 diabetes mellitus * 1  0/353 (0.00%)  1/356 (0.28%) 
Musculoskeletal and connective tissue disorders     
Bursitis * 1  0/353 (0.00%)  1/356 (0.28%) 
Haemarthrosis * 1  0/353 (0.00%)  1/356 (0.28%) 
Musculoskeletal chest pain * 1  1/353 (0.28%)  0/356 (0.00%) 
Musculoskeletal pain * 1  0/353 (0.00%)  1/356 (0.28%) 
Osteoarthritis * 1  1/353 (0.28%)  1/356 (0.28%) 
Pain in extremity * 1  0/353 (0.00%)  1/356 (0.28%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer * 1  0/353 (0.00%)  2/356 (0.56%) 
Invasive ductal breast carcinoma * 1  0/353 (0.00%)  1/356 (0.28%) 
Lung neoplasm malignant * 1  2/353 (0.57%)  0/356 (0.00%) 
Malignant melanoma of sites other than skin * 1  1/353 (0.28%)  0/356 (0.00%) 
Metastases to central nervous system * 1  1/353 (0.28%)  0/356 (0.00%) 
Prostate cancer * 1 [1]  1/224 (0.45%)  0/221 (0.00%) 
Nervous system disorders     
Intracranial aneurysm * 1  1/353 (0.28%)  0/356 (0.00%) 
Lethargy * 1  0/353 (0.00%)  1/356 (0.28%) 
Nerve root compression * 1  1/353 (0.28%)  0/356 (0.00%) 
Presyncope * 1  0/353 (0.00%)  1/356 (0.28%) 
Subarachnoid haemorrhage * 1  0/353 (0.00%)  1/356 (0.28%) 
Syncope * 1  1/353 (0.28%)  1/356 (0.28%) 
Transient ischaemic attack * 1  1/353 (0.28%)  0/356 (0.00%) 
Psychiatric disorders     
Completed suicide * 1  1/353 (0.28%)  0/356 (0.00%) 
Suicidal behaviour * 1  0/353 (0.00%)  1/356 (0.28%) 
Renal and urinary disorders     
Acute kidney injury * 1  2/353 (0.57%)  0/356 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  1/353 (0.28%)  0/356 (0.00%) 
Dyspnoea * 1  1/353 (0.28%)  0/356 (0.00%) 
Pulmonary embolism * 1  0/353 (0.00%)  1/356 (0.28%) 
Skin and subcutaneous tissue disorders     
Angioedema * 1  1/353 (0.28%)  0/356 (0.00%) 
Psoriasis * 1  1/353 (0.28%)  0/356 (0.00%) 
Vascular disorders     
Aortic aneurysm rupture * 1  0/353 (0.00%)  1/356 (0.28%) 
Aortic stenosis * 1  0/353 (0.00%)  1/356 (0.28%) 
Orthostatic hypotension * 1  0/353 (0.00%)  1/356 (0.28%) 
Peripheral arterial occlusive disease * 1  1/353 (0.28%)  0/356 (0.00%) 
Peripheral vascular disorder * 1  1/353 (0.28%)  0/356 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
[1]
This is gender specific event. The number of participants evaluable for this event are 224 and 221.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo PF-04950615 150 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   185/353 (52.41%)   205/356 (57.58%) 
Cardiac disorders     
Angina pectoris * 1  4/353 (1.13%)  5/356 (1.40%) 
Palpitations * 1  2/353 (0.57%)  4/356 (1.12%) 
Gastrointestinal disorders     
Abdominal pain * 1  4/353 (1.13%)  4/356 (1.12%) 
Constipation * 1  4/353 (1.13%)  8/356 (2.25%) 
Diarrhoea * 1  6/353 (1.70%)  12/356 (3.37%) 
Dyspepsia * 1  4/353 (1.13%)  1/356 (0.28%) 
Gastrooesophageal reflux disease * 1  5/353 (1.42%)  3/356 (0.84%) 
Nausea * 1  7/353 (1.98%)  7/356 (1.97%) 
Vomiting * 1  5/353 (1.42%)  4/356 (1.12%) 
General disorders     
Chest pain * 1  4/353 (1.13%)  2/356 (0.56%) 
Fatigue * 1  5/353 (1.42%)  7/356 (1.97%) 
Injection site bruising * 1  2/353 (0.57%)  5/356 (1.40%) 
Injection site erythema * 1  3/353 (0.85%)  9/356 (2.53%) 
Injection site haemorrhage * 1  2/353 (0.57%)  4/356 (1.12%) 
Injection site pain * 1  4/353 (1.13%)  6/356 (1.69%) 
Injection site pruritus * 1  0/353 (0.00%)  4/356 (1.12%) 
Injection site reaction * 1  5/353 (1.42%)  42/356 (11.80%) 
Non-cardiac chest pain * 1  5/353 (1.42%)  1/356 (0.28%) 
Pain * 1  5/353 (1.42%)  0/356 (0.00%) 
Infections and infestations     
Acute sinusitis * 1  3/353 (0.85%)  5/356 (1.40%) 
Bronchitis * 1  14/353 (3.97%)  13/356 (3.65%) 
Cellulitis * 1  4/353 (1.13%)  2/356 (0.56%) 
Gastroenteritis * 1  8/353 (2.27%)  2/356 (0.56%) 
Herpes zoster * 1  3/353 (0.85%)  4/356 (1.12%) 
Influenza * 1  7/353 (1.98%)  10/356 (2.81%) 
Nasopharyngitis * 1  27/353 (7.65%)  26/356 (7.30%) 
Pharyngitis * 1  3/353 (0.85%)  6/356 (1.69%) 
Pneumonia * 1  1/353 (0.28%)  8/356 (2.25%) 
Rhinitis * 1  1/353 (0.28%)  4/356 (1.12%) 
Sinusitis * 1  5/353 (1.42%)  10/356 (2.81%) 
Upper respiratory tract infection * 1  19/353 (5.38%)  14/356 (3.93%) 
Urinary tract infection * 1  6/353 (1.70%)  11/356 (3.09%) 
Injury, poisoning and procedural complications     
Contusion * 1  2/353 (0.57%)  4/356 (1.12%) 
Fall * 1  13/353 (3.68%)  10/356 (2.81%) 
Muscle strain * 1  1/353 (0.28%)  5/356 (1.40%) 
Investigations     
Alanine aminotransferase increased * 1  4/353 (1.13%)  0/356 (0.00%) 
Blood cortisol decreased * 1  5/353 (1.42%)  6/356 (1.69%) 
Blood creatine phosphokinase increased * 1  4/353 (1.13%)  3/356 (0.84%) 
Gamma-glutamyltransferase increased * 1  6/353 (1.70%)  1/356 (0.28%) 
Vitamin D decreased * 1  3/353 (0.85%)  5/356 (1.40%) 
Metabolism and nutrition disorders     
Diabetes mellitus * 1  3/353 (0.85%)  4/356 (1.12%) 
Hypoglycaemia * 1  4/353 (1.13%)  5/356 (1.40%) 
Type 2 diabetes mellitus * 1  5/353 (1.42%)  4/356 (1.12%) 
Vitamin D deficiency * 1  36/353 (10.20%)  19/356 (5.34%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  7/353 (1.98%)  13/356 (3.65%) 
Back pain * 1  8/353 (2.27%)  15/356 (4.21%) 
Muscle spasms * 1  8/353 (2.27%)  4/356 (1.12%) 
Musculoskeletal pain * 1  5/353 (1.42%)  7/356 (1.97%) 
Myalgia * 1  9/353 (2.55%)  8/356 (2.25%) 
Osteoarthritis * 1  3/353 (0.85%)  5/356 (1.40%) 
Pain in extremity * 1  11/353 (3.12%)  5/356 (1.40%) 
Tendonitis * 1  2/353 (0.57%)  4/356 (1.12%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma * 1  4/353 (1.13%)  1/356 (0.28%) 
Nervous system disorders     
Dizziness * 1  12/353 (3.40%)  1/356 (0.28%) 
Headache * 1  14/353 (3.97%)  8/356 (2.25%) 
Hypoaesthesia * 1  4/353 (1.13%)  1/356 (0.28%) 
Psychiatric disorders     
Anxiety * 1  5/353 (1.42%)  1/356 (0.28%) 
Depression * 1  3/353 (0.85%)  6/356 (1.69%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1 [1]  3/224 (1.34%)  1/221 (0.45%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  3/353 (0.85%)  6/356 (1.69%) 
Cough * 1  9/353 (2.55%)  8/356 (2.25%) 
Dyspnoea * 1  6/353 (1.70%)  3/356 (0.84%) 
Sleep apnoea syndrome * 1  2/353 (0.57%)  4/356 (1.12%) 
Skin and subcutaneous tissue disorders     
Rash * 1  4/353 (1.13%)  3/356 (0.84%) 
Vascular disorders     
Hypertension * 1  11/353 (3.12%)  12/356 (3.37%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
[1]
This is gender specific event. The number of participants evaluable for this event are 224 and 221.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01968954    
Other Study ID Numbers: B1481019
2013-002642-37 ( EudraCT Number )
SPIRE-HR ( Other Identifier: Alias Study Number )
First Submitted: October 21, 2013
First Posted: October 24, 2013
Results First Submitted: April 6, 2017
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017