Trial Outcomes & Findings for A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia (NCT NCT01968980)

NCT ID: NCT01968980

Last Updated: 2017-06-26

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

370 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2017-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Study STARTED	185	185
Overall Study COMPLETED	169	171
Overall Study NOT COMPLETED	16	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Study Death	0	1
Overall Study Adverse Event	1	3
Overall Study Does not meet entry criteria	1	3
Overall Study Withdrawal by Subject	13	5
Overall Study Other unspecified	1	2

Baseline Characteristics

A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Total n=370 Participants Total of all reporting groups
Age, Continuous	55.7 years STANDARD_DEVIATION 11.2 • n=5 Participants	56.5 years STANDARD_DEVIATION 10.5 • n=7 Participants	56.1 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	73 Participants n=7 Participants	155 Participants n=5 Participants
Sex: Female, Male Male	103 Participants n=5 Participants	112 Participants n=7 Participants	215 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=175 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=166 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12	-0.3 percent change Standard Deviation 18.30	-54.2 percent change Standard Deviation 29.34

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=175 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=166 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Total Cholesterol (TC) at Week 12	-0.0 percent change Standard Deviation 14.45	-37.0 percent change Standard Deviation 19.82

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=175 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=166 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12	0.4 percent change Standard Deviation 17.89	-49.9 percent change Standard Deviation 26.80

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=175 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=166 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12	0.4 percent change Standard Deviation 15.96	-47.5 percent change Standard Deviation 28.89

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=172 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=166 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Lipoprotein (a) at Week 12	2.2 percent change Standard Deviation 27.21	-26.4 percent change Standard Deviation 23.63

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=175 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=166 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12	-0.3 percent change Standard Deviation 12.99	6.3 percent change Standard Deviation 15.11

SECONDARY outcome

Timeframe: Baseline, Week 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 Week 24 (n =175, 173)	2.7 percent change Standard Deviation 25.38	-50.1 percent change Standard Deviation 32.94
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 Week 52 (n =169, 171)	3.5 percent change Standard Deviation 21.49	-45.3 percent change Standard Deviation 30.87

SECONDARY outcome

Timeframe: Baseline, Week 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52 Week 24 (n =176, 173)	1.6 percent change Standard Deviation 19.10	-34.4 percent change Standard Deviation 21.44
Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52 Week 52 (n =169, 171)	1.2 percent change Standard Deviation 15.82	-31.0 percent change Standard Deviation 21.50

SECONDARY outcome

Timeframe: Baseline, Week 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52 Week 24 (n =174, 173)	2.4 percent change Standard Deviation 24.06	-46.7 percent change Standard Deviation 29.88
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52 Week 52 (n =169, 171)	1.2 percent change Standard Deviation 19.25	-41.8 percent change Standard Deviation 29.99

SECONDARY outcome

Timeframe: Baseline, Week 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52 Week 24 (n =176, 171)	2.6 percent change Standard Deviation 19.29	-44.8 percent change Standard Deviation 30.40
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52 Week 52 (n =169, 171)	1.7 percent change Standard Deviation 16.45	-39.3 percent change Standard Deviation 28.89

SECONDARY outcome

Timeframe: Baseline, Week 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52 Week 24 (n =175, 172)	14.6 percent change Standard Deviation 157.93	-21.2 percent change Standard Deviation 48.77
Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52 Week 52 (n =168, 171)	1.3 percent change Standard Deviation 30.50	-15.1 percent change Standard Deviation 68.22

SECONDARY outcome

Timeframe: Baseline, Week 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52 Week 24 (n =174, 173)	0.9 percent change Standard Deviation 14.19	6.6 percent change Standard Deviation 12.85
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52 Week 52 (n =169, 171)	2.2 percent change Standard Deviation 14.51	4.7 percent change Standard Deviation 14.30

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52 Week 12 (n =175, 166)	7.1 percent change Standard Deviation 41.23	-8.7 percent change Standard Deviation 38.07
Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52 Week 24 (n =176, 173)	7.6 percent change Standard Deviation 51.97	-9.0 percent change Standard Deviation 40.01
Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52 Week 52 (n =169, 171)	4.9 percent change Standard Deviation 33.03	-3.4 percent change Standard Deviation 58.27

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 Week 12 (n =175, 166)	-0.5 percent change Standard Deviation 11.70	4.8 percent change Standard Deviation 12.15
Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 Week 24 (n =176, 172)	-0.6 percent change Standard Deviation 10.69	3.9 percent change Standard Deviation 10.72
Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 Week 52 (n =169, 171)	0.3 percent change Standard Deviation 12.02	3.0 percent change Standard Deviation 11.53

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52 Week 12 (n =175, 166)	-2.6 percent change Standard Deviation 13.34	-1.6 percent change Standard Deviation 15.68
Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52 Week 24 (n =175, 170)	-2.8 percent change Standard Deviation 11.88	-1.8 percent change Standard Deviation 13.45
Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52 Week 52 (n =167, 171)	-3.5 percent change Standard Deviation 11.90	-2.4 percent change Standard Deviation 14.50

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52 Week 12 (n =175, 166)	7.1 percent change Standard Deviation 41.23	-8.7 percent change Standard Deviation 38.07
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52 Week 24 (n =176, 173)	7.6 percent change Standard Deviation 51.97	-9.0 percent change Standard Deviation 40.01
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52 Week 52 (n =169, 171)	4.9 percent change Standard Deviation 33.03	-3.4 percent change Standard Deviation 58.27

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 Baseline (n= 185, 185)	150.0 milligram per deciliter (mg/dL) Standard Deviation 59.75	144.2 milligram per deciliter (mg/dL) Standard Deviation 41.96
Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 Change at Week 12 (n= 175, 166)	-3.0 milligram per deciliter (mg/dL) Standard Deviation 30.47	-79.1 milligram per deciliter (mg/dL) Standard Deviation 46.97

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in Total Cholesterol (TC) at Week 12 Baseline (n= 185, 185)	227.2 mg/dL Standard Deviation 67.31	220.7 mg/dL Standard Deviation 46.26
Absolute Change From Baseline in Total Cholesterol (TC) at Week 12 Change at Week 12 (n= 175, 166)	-2.8 mg/dL Standard Deviation 36.43	-83.2 mg/dL Standard Deviation 49.51

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 Baseline (n= 185, 185)	178.6 mg/dL Standard Deviation 66.64	170.4 mg/dL Standard Deviation 45.12
Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 Change at Week 12 (n= 175, 166)	-2.3 mg/dL Standard Deviation 36.24	-86.0 mg/dL Standard Deviation 51.09

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 Baseline (n= 185, 185)	115.9 mg/dL Standard Deviation 35.25	112.8 mg/dL Standard Deviation 26.26
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 Change at Week 12 (n= 175, 166)	-0.9 mg/dL Standard Deviation 20.51	-53.7 mg/dL Standard Deviation 33.07

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in Lipoprotein (a) at Week 12 Baseline (n= 184, 185)	58.8 mg/dL Standard Deviation 69.88	59.7 mg/dL Standard Deviation 63.38
Absolute Change From Baseline in Lipoprotein (a) at Week 12 Change at Week 12 (n= 172, 166)	-1.4 mg/dL Standard Deviation 14.02	-14.0 mg/dL Standard Deviation 17.91

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 Baseline (n= 185, 185)	48.6 mg/dL Standard Deviation 11.84	50.3 mg/dL Standard Deviation 11.40
Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 Change at Week 12 (n= 175, 166)	-0.6 mg/dL Standard Deviation 6.31	2.8 mg/dL Standard Deviation 7.89

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 Baseline (n =185, 185)	4.9 ratio Standard Deviation 1.81	4.6 ratio Standard Deviation 1.32
Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 Change at Week 12 (n =175, 166)	0.0 ratio Standard Deviation 1.00	-1.8 ratio Standard Deviation 1.29
Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 Change at Week 24 (n =174, 173)	0.0 ratio Standard Deviation 1.20	-1.7 ratio Standard Deviation 1.29
Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 Change at Week 52 (n =169, 171)	-0.0 ratio Standard Deviation 1.00	-1.5 ratio Standard Deviation 1.35

SECONDARY outcome

Timeframe: Baseline, Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 Baseline (n =185, 185)	0.8 ratio Standard Deviation 0.31	0.8 ratio Standard Deviation 0.23
Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 Change at Week 12 (n =175, 166)	0.0 ratio Standard Deviation 0.18	-0.4 ratio Standard Deviation 0.25
Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 Change at Week 24 (n =176, 171)	0.0 ratio Standard Deviation 0.17	-0.4 ratio Standard Deviation 0.25
Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 Change at Week 52 (n =169, 171)	0.0 ratio Standard Deviation 0.17	-0.3 ratio Standard Deviation 0.25

SECONDARY outcome

Timeframe: Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percentage of Participants 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 Week 12 (n =175, 166)	13.1 percentage of participants	83.1 percentage of participants
Percentage of Participants 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 Week 24 (n =175, 173)	13.1 percentage of participants	80.9 percentage of participants
Percentage of Participants 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 Week 52 (n =169, 171)	16.6 percentage of participants	70.8 percentage of participants

SECONDARY outcome

Timeframe: Week 12, 24, 52

Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percentage of Participants 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 Week 12 (n =175, 166)	1.1 percentage of participants	66.3 percentage of participants
Percentage of Participants 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 Week 24 (n =175, 173)	1.1 percentage of participants	60.7 percentage of participants
Percentage of Participants 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 Week 52 (n =169, 171)	0.6 percentage of participants	53.2 percentage of participants

SECONDARY outcome

Timeframe: Week 12, 24, 52

Population: Analysis was performed on all participants who received at least 1 dose of PF-04950615. Here, 'n' signifies those participants who were evaluable at specified time points.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Plasma PF-04950615 Concentrations at Week 12, 24 and 52 Week 12 (n =163)	6.23 microgram per milliliter Standard Deviation 5.657	—
Plasma PF-04950615 Concentrations at Week 12, 24 and 52 Week 24 (n =167)	7.00 microgram per milliliter Standard Deviation 6.351	—
Plasma PF-04950615 Concentrations at Week 12, 24 and 52 Week 52 (n =171)	4.84 microgram per milliliter Standard Deviation 5.384	—

SECONDARY outcome

Timeframe: Baseline up to the end of study (up to 58 weeks)

Population: Safety analysis set included all participants who received at least 1 dose of study treatment.

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. Participants with any of the above type 1 or type 3 hypersensitivity reactions and participants with any of the above injection site reactions were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 Participants Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Number of Participants With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions With Type 1 or 3 hypersensitivity reactions	0 participants	0 participants
Number of Participants With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions With Injection site reactions	1 participants	38 participants

SECONDARY outcome

Timeframe: Baseline up to the end of study (up to 58 weeks)

Population: Analysis was performed on all participants who received at least 1 dose of PF-04950615.

Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported in this outcome measure. 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.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Percentage of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) With positive ADA	49.7 percentage of participants	—
Percentage of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) With positive nAb	33 percentage of participants	—

Adverse Events

Placebo

Serious events: 22 serious events

Other events: 36 other events

Deaths: 0 deaths

PF--04950615

Serious events: 24 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=185 participants at risk Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	PF--04950615 n=185 participants at risk Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
General disorders Injection site reaction	0.54% 1/185 • Baseline up to the end of study (up to 58 weeks) 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	20.5% 38/185 • Baseline up to the end of study (up to 58 weeks) 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Influenza	3.2% 6/185 • Baseline up to the end of study (up to 58 weeks) 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	5.4% 10/185 • Baseline up to the end of study (up to 58 weeks) 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Nasopharyngitis	8.1% 15/185 • Baseline up to the end of study (up to 58 weeks) 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	8.1% 15/185 • Baseline up to the end of study (up to 58 weeks) 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Upper respiratory tract infection	3.8% 7/185 • Baseline up to the end of study (up to 58 weeks) 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	5.9% 11/185 • Baseline up to the end of study (up to 58 weeks) 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Headache	5.4% 10/185 • Baseline up to the end of study (up to 58 weeks) 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	5.4% 10/185 • Baseline up to the end of study (up to 58 weeks) 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.

Additional Information

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Results disclosure agreements

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