Trial Outcomes & Findings for Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia (NCT NCT02458287)

NCT ID: NCT02458287

Last Updated: 2017-12-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 299 participants
• Primary outcome timeframe: Baseline, Week 12
• Results posted on: 2017-12-19

Participant Flow

Participant milestones

Measure	Placebo Matched to Bococizumab 150 mg Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Placebo Matched to Bococizumab 75 mg Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Overall Study STARTED	50	100	49	100
Overall Study COMPLETED	50	96	46	97
Overall Study NOT COMPLETED	0	4	3	3

Reasons for withdrawal

Measure	Placebo Matched to Bococizumab 150 mg Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Placebo Matched to Bococizumab 75 mg Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Overall Study Adverse Event	0	0	0	1
Overall Study Lost to Follow-up	0	1	1	0
Overall Study Protocol Violation	0	1	0	0
Overall Study Withdrawal by Subject	0	2	2	1
Overall Study Relocated Out of State	0	0	0	1

Baseline Characteristics

Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia

Baseline characteristics by cohort

Measure	Placebo Matched to Bococizumab 150 mg n=50 Participants Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg n=100 Participants Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Placebo Matched to Bococizumab 75 mg n=49 Participants Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg n=100 Participants Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Total n=299 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 12 • n=5 Participants	58.9 years STANDARD_DEVIATION 11.5 • n=7 Participants	61 years STANDARD_DEVIATION 9.7 • n=5 Participants	59.9 years STANDARD_DEVIATION 10.1 • n=4 Participants	60 years STANDARD_DEVIATION 10.9 • n=21 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	42 Participants n=7 Participants	29 Participants n=5 Participants	48 Participants n=4 Participants	137 Participants n=21 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	58 Participants n=7 Participants	20 Participants n=5 Participants	52 Participants n=4 Participants	162 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Outcome measures

Measure	Placebo Matched to Bococizumab 150 mg n=50 Participants Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg n=95 Participants Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 + Bococizumab 75 mg Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 150 mg Dose Group and Matched Placebo	6.2 percent change Standard Error 3.57	-57.2 percent change Standard Error 2.57	—	—

PRIMARY outcome

Timeframe: Week 0 (Day 1)

Population: Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.

A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"

Outcome measures

Measure	Placebo Matched to Bococizumab 150 mg n=100 injections Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 + Bococizumab 75 mg Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 0 (Day 1)	98 percentage of injections	—	—	—

PRIMARY outcome

Timeframe: Week 2

Population: Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.

A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"

Outcome measures

Measure	Placebo Matched to Bococizumab 150 mg n=103 injections Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 + Bococizumab 75 mg Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 2	94.2 percentage of injections	—	—	—

PRIMARY outcome

Timeframe: Week 4

Population: Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.

A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"

Outcome measures

Measure	Placebo Matched to Bococizumab 150 mg n=104 injections Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 + Bococizumab 75 mg Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 4	93.3 percentage of injections	—	—	—

PRIMARY outcome

Timeframe: Week 6

Population: Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.

A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"

Outcome measures

Measure	Placebo Matched to Bococizumab 150 mg n=101 injections Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 + Bococizumab 75 mg Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 6	96 percentage of injections	—	—	—

PRIMARY outcome

Timeframe: Week 8

Population: Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.

A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"

Outcome measures

Measure	Placebo Matched to Bococizumab 150 mg n=100 injections Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 + Bococizumab 75 mg Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 8	99 percentage of injections	—	—	—

PRIMARY outcome

Timeframe: Week 10

Population: Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.

A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"

Outcome measures

Measure	Placebo Matched to Bococizumab 150 mg n=101 injections Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 + Bococizumab 75 mg Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 10	98.0 percentage of injections	—	—	—

SECONDARY outcome

Timeframe: Week 0 (Day 1), 2, 4, 6, 8, 10

Population: Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.

A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"

Outcome measures

Measure	Placebo Matched to Bococizumab 150 mg n=102 injections Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg n=205 injections Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 + Bococizumab 75 mg Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 2, 4, 6, 8 and 10 Week 0	97.0 percentage of injections	97.5 percentage of injections	—	—
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 2, 4, 6, 8 and 10 Week 2	94.1 percentage of injections	94.1 percentage of injections	—	—
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 2, 4, 6, 8 and 10 Week 4	99.0 percentage of injections	96.1 percentage of injections	—	—
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 2, 4, 6, 8 and 10 Week 6	97.0 percentage of injections	96.5 percentage of injections	—	—
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 2, 4, 6, 8 and 10 Week 8	100.0 percentage of injections	99.5 percentage of injections	—	—
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 2, 4, 6, 8 and 10 Week 10	97.0 percentage of injections	97.5 percentage of injections	—	—

SECONDARY outcome

Timeframe: Week 0 (Day 1), 4, 8

Population: Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms as pre-specified in protocol.

As per the OAT, a 'successful' injection was based on observer's response for the question - "Was the administration successful?''. Observer's response being 'Yes' corresponded to a successful injection.

Outcome measures

Measure	Placebo Matched to Bococizumab 150 mg n=105 injections Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg n=103 injections Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 + Bococizumab 75 mg n=206 injections Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Percentage of Injections That Met the Definition for Successful Assessment Using the Observer Assessment Tool (OAT) for Bococizumab 150 mg Dose, Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 4 and 8 Week 0	99.0 percentage of injections	98.0 percentage of injections	98.5 percentage of injections	—
Percentage of Injections That Met the Definition for Successful Assessment Using the Observer Assessment Tool (OAT) for Bococizumab 150 mg Dose, Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 4 and 8 Week 4	93.2 percentage of injections	99.0 percentage of injections	96.1 percentage of injections	—
Percentage of Injections That Met the Definition for Successful Assessment Using the Observer Assessment Tool (OAT) for Bococizumab 150 mg Dose, Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 4 and 8 Week 8	100.0 percentage of injections	100.0 percentage of injections	100.0 percentage of injections	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Outcome measures

Measure	Placebo Matched to Bococizumab 150 mg n=45 Participants Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg n=97 Participants Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 + Bococizumab 75 mg Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 75 mg Dose Group and Matched Placebo	6.9 percent change Standard Error 3.74	-36.0 percent change Standard Error 2.55	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Outcome measures

Measure	Placebo Matched to Bococizumab 150 mg n=50 Participants Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg n=97 Participants Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 + Bococizumab 75 mg n=45 Participants Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg n=97 Participants Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12	3.8 percent change Standard Error 2.33	-35.9 percent change Standard Error 1.67	4.7 percent change Standard Error 2.45	-22.0 percent change Standard Error 1.66

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Outcome measures

Measure	Placebo Matched to Bococizumab 150 mg n=50 Participants Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg n=96 Participants Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 + Bococizumab 75 mg n=45 Participants Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg n=97 Participants Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12	4.5 percent change Standard Error 3.44	-53.4 percent change Standard Error 2.48	4.3 percent change Standard Error 3.62	-31.5 percent change Standard Error 2.46

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Outcome measures

Measure	Placebo Matched to Bococizumab 150 mg n=50 Participants Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg n=97 Participants Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 + Bococizumab 75 mg n=44 Participants Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg n=97 Participants Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Percent Change From Baseline in Fasting Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12	4.1 percent change Standard Error 3.12	-52.1 percent change Standard Error 2.24	4.7 percent change Standard Error 3.30	-32.5 percent change Standard Error 2.23

SECONDARY outcome

Timeframe: Baseline up to 18 weeks

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

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug up to the follow up visit (up to 18 weeks), that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.

Outcome measures

Measure	Placebo Matched to Bococizumab 150 mg n=50 Participants Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg n=100 Participants Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 + Bococizumab 75 mg n=49 Participants Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg n=100 Participants Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	17 participants	42 participants	20 participants	33 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	0 participants	2 participants	3 participants	2 participants

SECONDARY outcome

Timeframe: Baseline up to 18 weeks

Population: Safety analysis set included all participants who received at least 1 dose of study treatment. Participants who received at least 1 dose of bococizumab were evaluable for this outcome measure. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. Participants with their ADA titer levels >=6.23 were considered as ADA positive and participants with their nAb titer level >=1.58 were considered as nAb positive.

Outcome measures

Measure	Placebo Matched to Bococizumab 150 mg n=97 Participants Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg n=99 Participants Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 + Bococizumab 75 mg Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) ADA Positive	39.2 percentage of participants	22.2 percentage of participants	—	—
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) nAb Positive	18.6 percentage of participants	11.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Analysis set included all participants who received at least one dose of study medication. Participants who received at least 1 dose of Bococizumab were evaluable for this outcome measure. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Outcome measures

Measure	Placebo Matched to Bococizumab 150 mg n=92 Participants Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg n=90 Participants Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 + Bococizumab 75 mg Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Plasma Concentration of Bococizumab at Week 12	6.68 microgram per milliliter Standard Deviation 6.169	2.08 microgram per milliliter Standard Deviation 1.413	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Safety analysis set included all participants who received at least 1 dose of study treatment. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

PCSK9 is an enzyme encoded by the PCSK9 gene in humans on chromosome. It is the 9th member of the proprotein convertase family of proteins that activate other proteins.

Outcome measures

Measure	Placebo Matched to Bococizumab 150 mg n=47 Participants Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg n=93 Participants Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 + Bococizumab 75 mg n=43 Participants Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg n=92 Participants Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Plasma Concentration of Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) at Week 12	297.9 nanogram per milliliter Standard Deviation 102.11	2835.3 nanogram per milliliter Standard Deviation 901.15	341.8 nanogram per milliliter Standard Deviation 102.91	2370.9 nanogram per milliliter Standard Deviation 1016.4

Adverse Events

Placebo Matched to Bococizumab 150 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Bococizumab 150 mg

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo Matched to Bococizumab 75 mg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Bococizumab 75 mg

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo Matched to Bococizumab 150 mg n=50 participants at risk Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg n=100 participants at risk Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Placebo Matched to Bococizumab 75 mg n=49 participants at risk Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg n=100 participants at risk Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Eye disorders Retinal detachment	0.00% 0/50 • Baseline up to 18 weeks The same event may appear as both an AE and a 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% 0/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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% 0/49 • Baseline up to 18 weeks The same event may appear as both an AE and a 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.	1.0% 1/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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 Gastrointestinal haemorrhage	0.00% 0/50 • Baseline up to 18 weeks The same event may appear as both an AE and a 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.	1.0% 1/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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% 0/49 • Baseline up to 18 weeks The same event may appear as both an AE and a 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% 0/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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 Chronic tonsillitis	0.00% 0/50 • Baseline up to 18 weeks The same event may appear as both an AE and a 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% 0/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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.	2.0% 1/49 • Baseline up to 18 weeks The same event may appear as both an AE and a 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% 0/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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 Pneumonia	0.00% 0/50 • Baseline up to 18 weeks The same event may appear as both an AE and a 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% 0/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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.	2.0% 1/49 • Baseline up to 18 weeks The same event may appear as both an AE and a 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% 0/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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 Lumbar spinal stenosis	0.00% 0/50 • Baseline up to 18 weeks The same event may appear as both an AE and a 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% 0/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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.	2.0% 1/49 • Baseline up to 18 weeks The same event may appear as both an AE and a 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% 0/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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 Polymyalgia rheumatica	0.00% 0/50 • Baseline up to 18 weeks The same event may appear as both an AE and a 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.	1.0% 1/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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% 0/49 • Baseline up to 18 weeks The same event may appear as both an AE and a 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% 0/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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 Chronic obstructive pulmonary disease	0.00% 0/50 • Baseline up to 18 weeks The same event may appear as both an AE and a 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% 0/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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% 0/49 • Baseline up to 18 weeks The same event may appear as both an AE and a 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.	1.0% 1/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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.

Other adverse events

Measure	Placebo Matched to Bococizumab 150 mg n=50 participants at risk Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 150 mg n=100 participants at risk Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Placebo Matched to Bococizumab 75 mg n=49 participants at risk Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.	Bococizumab 75 mg n=100 participants at risk Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks.
Gastrointestinal disorders Diarrhoea	6.0% 3/50 • Baseline up to 18 weeks The same event may appear as both an AE and a 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.	1.0% 1/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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.	2.0% 1/49 • Baseline up to 18 weeks The same event may appear as both an AE and a 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.	2.0% 2/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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 Nasopharyngitis	0.00% 0/50 • Baseline up to 18 weeks The same event may appear as both an AE and a 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.	2.0% 2/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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.	6.1% 3/49 • Baseline up to 18 weeks The same event may appear as both an AE and a 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.	1.0% 1/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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	6.0% 3/50 • Baseline up to 18 weeks The same event may appear as both an AE and a 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.	3.0% 3/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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% 2/49 • Baseline up to 18 weeks The same event may appear as both an AE and a 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.	2.0% 2/100 • Baseline up to 18 weeks The same event may appear as both an AE and a 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.

Additional Information

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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