Trial Outcomes & Findings for Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins (NCT NCT02135029)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

184 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2017-12-14

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Overall Study STARTED	73	74	37
Overall Study Treated	73	74	36
Overall Study COMPLETED	69	69	34
Overall Study NOT COMPLETED	4	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Overall Study Adverse Event	2	2	2
Overall Study Lost to Follow-up	0	1	0
Overall Study Withdrawal by Subject	2	0	1
Overall Study Other	0	1	0
Overall Study Death	0	1	0

Baseline Characteristics

Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.	Total n=184 Participants Total of all reporting groups
Age, Continuous	63.2 years STANDARD_DEVIATION 8.4 • n=5 Participants	64 years STANDARD_DEVIATION 9.2 • n=7 Participants	65.1 years STANDARD_DEVIATION 7.6 • n=5 Participants	63.9 years STANDARD_DEVIATION 8.5 • n=4 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	40 Participants n=7 Participants	21 Participants n=5 Participants	99 Participants n=4 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	34 Participants n=7 Participants	16 Participants n=5 Participants	85 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

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

Outcome measures

Outcome measures
Measure	Placebo n=70 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=71 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=35 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12	2.4 percent (%) change Standard Deviation 12.86	-52.0 percent (%) change Standard Deviation 22.75	-32.6 percent (%) change Standard Deviation 20.98

SECONDARY outcome

Timeframe: Baseline, Week 12, 24

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=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24 Percent change at Week 12	1.3 percent change Standard Deviation 9.92	-37.0 percent change Standard Deviation 17.08	-25.7 percent change Standard Deviation 16.98
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24 Percent change at Week 24	-0.5 percent change Standard Deviation 11.77	-31.2 percent change Standard Deviation 21.31	-26.8 percent change Standard Deviation 16.64

SECONDARY outcome

Timeframe: Baseline, Week 12, 24

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=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24 Percent change at Week 12	0.9 percent change Standard Deviation 11.64	-46.0 percent change Standard Deviation 22.19	-27.2 percent change Standard Deviation 18.75
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24 Percent change at Week 24	0.1 percent change Standard Deviation 13.34	-39.1 percent change Standard Deviation 26.85	-28.1 percent change Standard Deviation 20.20

SECONDARY outcome

Timeframe: Baseline, Week 12, 24

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=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24 Percent change at Week 12	1.1 percent change Standard Deviation 11.16	-50.0 percent change Standard Deviation 21.06	-32.5 percent change Standard Deviation 21.24
Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24 Percent change at Week 24	-0.3 percent change Standard Deviation 14.46	-41.9 percent change Standard Deviation 26.00	-34.0 percent change Standard Deviation 21.14

SECONDARY outcome

Timeframe: Baseline, Week 12, 24

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=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24 Percent change at Week 24	0.8 percent change Standard Deviation 34.59	-16.6 percent change Standard Deviation 31.71	4.1 percent change Standard Deviation 31.33
Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24 Percent change at Week 12	2.0 percent change Standard Deviation 33.13	-21.5 percent change Standard Deviation 39.77	5.1 percent change Standard Deviation 29.77

SECONDARY outcome

Timeframe: Baseline, Week 12, 24

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=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24 Percent change at Week 12	0.4 percent change Standard Deviation 12.31	13.2 percent change Standard Deviation 19.73	0.4 percent change Standard Deviation 13.51
Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24 Percent change at Week 24	-0.3 percent change Standard Deviation 12.34	11.5 percent change Standard Deviation 18.84	0.2 percent change Standard Deviation 14.02

SECONDARY outcome

Timeframe: Baseline, Week 24

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

Outcome measures

Outcome measures
Measure	Placebo n=69 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=70 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=33 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24	1.6 percent change Standard Deviation 15.62	-42.7 percent change Standard Deviation 29.50	-33.3 percent change Standard Deviation 20.91

SECONDARY outcome

Timeframe: Baseline, Week 12, 24

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=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24 Percent change at Week 24	-3.3 percent change Standard Deviation 30.01	-13.6 percent change Standard Deviation 40.58	-21.9 percent change Standard Deviation 30.19
Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24 Percent change at Week 12	2.2 percent change Standard Deviation 26.77	-12.5 percent change Standard Deviation 27.42	-20.7 percent change Standard Deviation 23.96

SECONDARY outcome

Timeframe: Baseline, Week 12, 24

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=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24 Percent change at Week 12	1.9 percent change Standard Deviation 11.38	8.0 percent change Standard Deviation 14.94	-2.8 percent change Standard Deviation 11.66
Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24 Percent change at Week 24	2.3 percent change Standard Deviation 11.91	8.0 percent change Standard Deviation 14.66	-2.2 percent change Standard Deviation 11.66

SECONDARY outcome

Timeframe: Baseline, Week 12, 24

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=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24 Percent change at Week 24	-2.2 percent change Standard Deviation 12.80	3.9 percent change Standard Deviation 13.21	-0.6 percent change Standard Deviation 19.96
Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24 Percent change at Week 12	-0.4 percent change Standard Deviation 10.83	4.1 percent change Standard Deviation 13.45	-3.2 percent change Standard Deviation 12.78

SECONDARY outcome

Timeframe: Baseline, Week 12, 24

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=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24 Percent change at Week 12	2.2 percent change Standard Deviation 26.77	-12.5 percent change Standard Deviation 27.42	-20.7 percent change Standard Deviation 23.96
Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24 Percent change at Week 24	-3.3 percent change Standard Deviation 30.01	-13.6 percent change Standard Deviation 40.58	-21.9 percent change Standard Deviation 30.19

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=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 Baseline	182.1 milligrams per deciliter (mg/dL) Standard Deviation 46.96	168.8 milligrams per deciliter (mg/dL) Standard Deviation 47.31	169.9 milligrams per deciliter (mg/dL) Standard Deviation 46.44
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 Change at Week 12	3.1 milligrams per deciliter (mg/dL) Standard Deviation 21.12	-88.0 milligrams per deciliter (mg/dL) Standard Deviation 43.82	-56.5 milligrams per deciliter (mg/dL) Standard Deviation 40.68

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=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 Baseline	262.3 mg/dL Standard Deviation 51.20	250.1 mg/dL Standard Deviation 54.50	256.2 mg/dL Standard Deviation 53.55
Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 Change at Week 12	3.2 mg/dL Standard Deviation 25.46	-93.8 mg/dL Standard Deviation 47.94	-67.7 mg/dL Standard Deviation 46.85

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=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12 Baseline	51.6 mg/dL Standard Deviation 13.92	51.1 mg/dL Standard Deviation 15.02	55.7 mg/dL Standard Deviation 13.50
Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12 Change at Week 12	0.1 mg/dL Standard Deviation 6.31	6.0 mg/dL Standard Deviation 8.01	-0.5 mg/dL Standard Deviation 7.07

SECONDARY outcome

Timeframe: Baseline, Week 12

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

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 Baseline	210.7 mg/dL Standard Deviation 49.75	199.2 mg/dL Standard Deviation 50.40	200.5 mg/dL Standard Deviation 50.16
Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 Change at Week 12	2.2 mg/dL Standard Deviation 22.69	-99.8 mg/dL Standard Deviation 46.99	-67.1 mg/dL Standard Deviation 45.59

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Due to changes in planned analyses the data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

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=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 Change at Week 12	1.1 mg/dL Standard Deviation 15.08	-57.5 mg/dL Standard Deviation 28.57	-35.3 mg/dL Standard Deviation 25.66
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 Baseline	133.3 mg/dL Standard Deviation 27.00	125.8 mg/dL Standard Deviation 31.43	124.6 mg/dL Standard Deviation 29.82

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=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12 Baseline	32.0 mg/dL Standard Deviation 38.46	27.1 mg/dL Standard Deviation 36.31	31.7 mg/dL Standard Deviation 38.26
Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12 Change at Week 12	0.7 mg/dL Standard Deviation 5.19	-5.8 mg/dL Standard Deviation 7.93	1.9 mg/dL Standard Deviation 5.27

SECONDARY outcome

Timeframe: Baseline, Week 12, 24

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=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24 Baseline	5.4 ratio Standard Deviation 1.53	5.2 ratio Standard Deviation 1.45	4.8 ratio Standard Deviation 1.27
Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24 Absolute change at Week 12	0.1 ratio Standard Deviation 0.76	-2.3 ratio Standard Deviation 1.13	-1.3 ratio Standard Deviation 1.13
Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24 Absolute change at Week 24	0.0 ratio Standard Deviation 0.77	-2.0 ratio Standard Deviation 1.35	-1.3 ratio Standard Deviation 1.13

SECONDARY outcome

Timeframe: Baseline, Week 12, 24

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=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24 Baseline	0.9 ratio Standard Deviation 0.25	0.9 ratio Standard Deviation 0.24	0.8 ratio Standard Deviation 0.21
Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24 Absolute change at Week 12	-0.0 ratio Standard Deviation 0.10	-0.4 ratio Standard Deviation 0.21	-0.2 ratio Standard Deviation 0.17
Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24 Absolute change at Week 24	-0.0 ratio Standard Deviation 0.12	-0.4 ratio Standard Deviation 0.25	-0.2 ratio Standard Deviation 0.18

SECONDARY outcome

Timeframe: Week 12, 24

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=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 Week 24	0 percentage of participants	61.4 percentage of participants	45.5 percentage of participants
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 Week 12	1.4 percentage of participants	71.8 percentage of participants	42.9 percentage of participants

SECONDARY outcome

Timeframe: Week 12, 24

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=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=37 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 Week 12	0 percentage of participants	45.1 percentage of participants	14.3 percentage of participants
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 Week 24	0 percentage of participants	41.4 percentage of participants	15.2 percentage of participants

SECONDARY outcome

Timeframe: Week 12 and 24

Population: Safety analysis set included all participants who received at least 1 dose of study treatment. Here, 'N' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time point for the arm.

Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.4 micrograms per milliliter \[mcg/mL\]) to zero. Participants who received PF-04950615 150 mg were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Plasma PF-04950615 Concentrations at Weeks 12 and 24 Week 24	7.38 mcg/mL Standard Deviation 7.890	—	—
Plasma PF-04950615 Concentrations at Weeks 12 and 24 Week 12	10.21 mcg/mL Standard Deviation 9.309	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 30

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

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=36 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations Type 1 and 3 hypersensitivity reactions	1 participants	0 participants	0 participants
Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations Myalgia	13 participants	13 participants	7 participants
Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations Myopathy	0 participants	0 participants	0 participants
Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations LFT Elevations	1 participants	2 participants	1 participants
Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations Injection site reactions	4 participants	16 participants	0 participants
Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations CK Elevations	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline up to Week 30

Population: Safety analysis set included all participants who received at least 1 dose of study treatment. Here, 'N' signifies those participants who were evaluable for this outcome measure. Participants who received PF-04950615 150 mg were evaluable for this outcome measure.

Participants with at least one positive ADA titer greater than or equal to (\>=) 6.23 or positive nAb titer \>=4.32 were reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb) ADA	35 participants	—	—
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb) nAb	21 participants	—	—

SECONDARY outcome

Timeframe: Week 4, 12, 24 and 30 (Follow-up)

Population: Safety analysis set: all participants who received at least 1 dose of study treatment. Here, 'N' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time point for the arm. Participants who received PF-04950615 150 mg were evaluable for this outcome measure.

Titer levels of participants who tested positive for ADA and nAb are reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively ADA Titer: Week 12	9.49 titer Standard Deviation 1.646	—	—
Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively ADA Titer: Week 24	9.46 titer Standard Deviation 2.196	—	—
Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively ADA Titer: Week 30	10.12 titer Standard Deviation 2.981	—	—
Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively ADA Titer: Week 4	9.94 titer Standard Deviation 1.181	—	—
Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively nAb Titer: Week 12	6.05 titer Standard Deviation 2.440	—	—
Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively nAb Titer: Week 24	5.28 titer Standard Deviation 1.358	—	—
Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively nAb Titer: Week 30	6.09 titer Standard Deviation 2.135	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 30

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

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 Participants Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=36 Participants Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations Myopathy	0 percentage of participants 0.12	0 percentage of participants 0.25	0 percentage of participants 0.18
Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations CK Elevations	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations LFT Elevations	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations Myalgia	9.6 percentage of participants 0.10	10.8 percentage of participants 0.21	16.7 percentage of participants 0.17

Adverse Events

Placebo

Serious events: 7 serious events

Other events: 44 other events

Deaths: 0 deaths

PF-04950615 150 Milligram (mg) + Placebo

Serious events: 8 serious events

Other events: 41 other events

Deaths: 0 deaths

Atorvastatin 40 mg + Placebo

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=73 participants at risk Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 participants at risk Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=36 participants at risk Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Cardiac disorders Angina pectoris	2.7% 2/73 The same event may appear as both an 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 nonserious event during the study.	1.4% 1/74 The same event may appear as both an 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 nonserious event during the study.	2.8% 1/36 The same event may appear as both an 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 nonserious event during the study.
Cardiac disorders Angina unstable	1.4% 1/73 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/74 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/36 The same event may appear as both an 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 nonserious event during the study.
Cardiac disorders Coronary artery disease	1.4% 1/73 The same event may appear as both an 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 nonserious event during the study.	1.4% 1/74 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/36 The same event may appear as both an 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 nonserious event during the study.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/73 The same event may appear as both an 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 nonserious event during the study.	1.4% 1/74 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/36 The same event may appear as both an 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 nonserious event during the study.
General disorders Chest pain	0.00% 0/73 The same event may appear as both an 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 nonserious event during the study.	1.4% 1/74 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/36 The same event may appear as both an 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 nonserious event during the study.
General disorders Multi-organ failure	0.00% 0/73 The same event may appear as both an 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 nonserious event during the study.	1.4% 1/74 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/36 The same event may appear as both an 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 nonserious event during the study.
General disorders Non-cardiac chest pain	0.00% 0/73 The same event may appear as both an 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 nonserious event during the study.	1.4% 1/74 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/36 The same event may appear as both an 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 nonserious event during the study.
Infections and infestations Bronchitis	0.00% 0/73 The same event may appear as both an 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 nonserious event during the study.	1.4% 1/74 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/36 The same event may appear as both an 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 nonserious event during the study.
Infections and infestations Bursitis infective	1.4% 1/73 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/74 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/36 The same event may appear as both an 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 nonserious event during the study.
Infections and infestations Diabetic foot infection	1.4% 1/73 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/74 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/36 The same event may appear as both an 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 nonserious event during the study.
Infections and infestations Sepsis	0.00% 0/73 The same event may appear as both an 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 nonserious event during the study.	1.4% 1/74 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/36 The same event may appear as both an 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 nonserious event during the study.
Injury, poisoning and procedural complications Coronary artery restenosis	0.00% 0/73 The same event may appear as both an 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 nonserious event during the study.	1.4% 1/74 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/36 The same event may appear as both an 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 nonserious event during the study.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	1.4% 1/73 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/74 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/36 The same event may appear as both an 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 nonserious event during the study.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	1.4% 1/73 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/74 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/36 The same event may appear as both an 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 nonserious event during the study.
Nervous system disorders Cerebral infarction	0.00% 0/73 The same event may appear as both an 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 nonserious event during the study.	1.4% 1/74 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/36 The same event may appear as both an 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 nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/73 The same event may appear as both an 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 nonserious event during the study.	1.4% 1/74 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/36 The same event may appear as both an 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 nonserious event during the study.
Vascular disorders Hypotension	0.00% 0/73 The same event may appear as both an 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 nonserious event during the study.	1.4% 1/74 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/36 The same event may appear as both an 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 nonserious event during the study.

Measure	Placebo n=73 participants at risk Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	PF-04950615 150 Milligram (mg) + Placebo n=74 participants at risk Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks.	Atorvastatin 40 mg + Placebo n=36 participants at risk Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks.
Gastrointestinal disorders Abdominal pain	5.5% 4/73 The same event may appear as both an 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 nonserious event during the study.	1.4% 1/74 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/36 The same event may appear as both an 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 nonserious event during the study.
Gastrointestinal disorders Constipation	5.5% 4/73 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/74 The same event may appear as both an 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 nonserious event during the study.	2.8% 1/36 The same event may appear as both an 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 nonserious event during the study.
Gastrointestinal disorders Diarrhoea	5.5% 4/73 The same event may appear as both an 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 nonserious event during the study.	5.4% 4/74 The same event may appear as both an 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 nonserious event during the study.	2.8% 1/36 The same event may appear as both an 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 nonserious event during the study.
Gastrointestinal disorders Nausea	2.7% 2/73 The same event may appear as both an 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 nonserious event during the study.	5.4% 4/74 The same event may appear as both an 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 nonserious event during the study.	5.6% 2/36 The same event may appear as both an 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 nonserious event during the study.
General disorders Fatigue	8.2% 6/73 The same event may appear as both an 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 nonserious event during the study.	4.1% 3/74 The same event may appear as both an 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 nonserious event during the study.	11.1% 4/36 The same event may appear as both an 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 nonserious event during the study.
General disorders Injection site reaction	2.7% 2/73 The same event may appear as both an 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 nonserious event during the study.	18.9% 14/74 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/36 The same event may appear as both an 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 nonserious event during the study.
Immune system disorders Seasonal allergy	1.4% 1/73 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/74 The same event may appear as both an 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 nonserious event during the study.	5.6% 2/36 The same event may appear as both an 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 nonserious event during the study.
Infections and infestations Gastroenteritis viral	1.4% 1/73 The same event may appear as both an 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 nonserious event during the study.	1.4% 1/74 The same event may appear as both an 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 nonserious event during the study.	5.6% 2/36 The same event may appear as both an 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 nonserious event during the study.
Infections and infestations Upper respiratory tract infection	5.5% 4/73 The same event may appear as both an 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 nonserious event during the study.	1.4% 1/74 The same event may appear as both an 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 nonserious event during the study.	2.8% 1/36 The same event may appear as both an 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 nonserious event during the study.
Infections and infestations Vulvovaginal mycotic infection	5.3% 2/38 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/40 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/21 The same event may appear as both an 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 nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	8.2% 6/73 The same event may appear as both an 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 nonserious event during the study.	6.8% 5/74 The same event may appear as both an 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 nonserious event during the study.	2.8% 1/36 The same event may appear as both an 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 nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	8.2% 6/73 The same event may appear as both an 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 nonserious event during the study.	2.7% 2/74 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/36 The same event may appear as both an 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 nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	11.0% 8/73 The same event may appear as both an 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 nonserious event during the study.	9.5% 7/74 The same event may appear as both an 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 nonserious event during the study.	8.3% 3/36 The same event may appear as both an 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 nonserious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	17.8% 13/73 The same event may appear as both an 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 nonserious event during the study.	17.6% 13/74 The same event may appear as both an 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 nonserious event during the study.	19.4% 7/36 The same event may appear as both an 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 nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	9.6% 7/73 The same event may appear as both an 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 nonserious event during the study.	5.4% 4/74 The same event may appear as both an 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 nonserious event during the study.	2.8% 1/36 The same event may appear as both an 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 nonserious event during the study.
Nervous system disorders Dizziness	4.1% 3/73 The same event may appear as both an 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 nonserious event during the study.	2.7% 2/74 The same event may appear as both an 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 nonserious event during the study.	8.3% 3/36 The same event may appear as both an 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 nonserious event during the study.
Nervous system disorders Headache	2.7% 2/73 The same event may appear as both an 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 nonserious event during the study.	5.4% 4/74 The same event may appear as both an 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 nonserious event during the study.	2.8% 1/36 The same event may appear as both an 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 nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/73 The same event may appear as both an 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 nonserious event during the study.	1.4% 1/74 The same event may appear as both an 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 nonserious event during the study.	5.6% 2/36 The same event may appear as both an 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 nonserious event during the study.
Skin and subcutaneous tissue disorders Urticaria	1.4% 1/73 The same event may appear as both an 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 nonserious event during the study.	0.00% 0/74 The same event may appear as both an 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 nonserious event during the study.	5.6% 2/36 The same event may appear as both an 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 nonserious event during the study.