Phase 3
Completed N=299
Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia
Source: ClinicalTrials.gov NCT02458287 ↗Enrolled (actual)
299
Serious AEs
2.3%
Results posted
Dec 2017
Primary outcomePrimary: 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; -57.2 percent change — p=<0.001
◆ Published Evidence
Highly cited
363citations · ~40 / year
Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab.
Summary
This study is a multicenter, randomized study in subjects with high cholesterol receiving statins to assess the efficacy to lower LDL-C, the safety, tolerability and actual use of bococizumab and an autoinjector (pre-filled pen).
Linked Publications
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Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; -57.2 | <0.001 sig |
| PRIMARY 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 | — |
| PRIMARY 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 | — |
| PRIMARY 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 | — |
| PRIMARY 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 | — |
| PRIMARY 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 | — |
| PRIMARY 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 | — |
| SECONDARY 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 |
97.0; 97.5; 94.1; 94.1; 99.0; 96.1 | — |
| SECONDARY 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 |
99.0; 98.0; 98.5; 93.2; 99.0; 96.1 | — |
| SECONDARY 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; -36.0 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 |
3.8; -35.9; 4.7; -22.0 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 |
4.5; -53.4; 4.3; -31.5 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 |
4.1; -52.1; 4.7; -32.5 | <0.001 sig |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
17; 42; 20; 33; 0; 2 | — |
| SECONDARY Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) |
39.2; 22.2; 18.6; 11.1 | — |
| SECONDARY Plasma Concentration of Bococizumab at Week 12 |
6.68; 2.08 | — |
| SECONDARY Plasma Concentration of Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) at Week 12 |
297.9; 2835.3; 341.8; 2370.9 | — |
Eligibility Criteria
Inclusion Criteria
- Treated with a statin - Fasting LDL-C >=70mg/dL and triglycerides <=400mg/dL
Exclusion Criteria
- Pregnant or breastfeeding females - Cardiovascular or cerebrovascular event or procedures during the past 90 days - Congestive heart failure NYHA class IV - Poorly controlled hypertension
Data sourced from ClinicalTrials.gov (NCT02458287) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.