Phase 3
N=711
Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
Hyperlipidemia
Bottom Line
View on ClinicalTrials.gov: NCT01968954 ↗Enrolled (actual)
711
Serious AEs
12.0%
Results posted
May 2017
Primary outcome: Primary: Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 — 1.0; -55.6 percent change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bococizumab (PF-04950615;RN316) (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 |
1.0; -55.6 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52 |
1.0; -35.1; 3.2; -31.7; 1.8; -27.3 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52 |
1.3; -50.0; 4.7; -46.2; 2.3; -38.9 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52 |
0.3; -51.1; 3.5; -47.3; 1.9; -39.1 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52 |
4.7; 1.9; 1.9; 4.4; 1.1; 17.3 | 0.860 |
| SECONDARY Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52 |
1.9; 6.6; 1.0; 7.8; 2.0; 5.3 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Primary Hyperlipidemia |
1.5; -56.8 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia |
-1.0; -50.9 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52 |
6.3; -50.0; 5.2; -40.9 | — |
| SECONDARY Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off |
7.2; -50.8; 6.2; -41.1; 3.0; -46.9 | — |
| SECONDARY Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52 |
5.9; -9.4; 7.0; -13.8; 0.6; -9.3 | — |
| SECONDARY Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52 |
-0.3; 3.7; -0.8; 4.3; 0.4; 3.3 | — |
| SECONDARY Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52 |
-1.8; -1.9; -3.7; -1.9; -3.0; -1.6 | — |
| SECONDARY Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52 |
5.9; -9.4; 7.0; -13.8; 0.6; -9.3 | — |
| SECONDARY Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off |
111.2; 112.8; 0.4; -63.4; 126.5; 125.7 | — |
| SECONDARY Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52 |
114.3; 115.5; -0.2; -63.3; 5.5; -56.0 | — |
| SECONDARY Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52 |
186.0; 189.0; 0.6; -66.8; 5.1; -60.1 | — |
| SECONDARY Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52 |
137.2; 140.1; 0.3; -69.8; 5.2; -63.6 | — |
| SECONDARY Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52 |
94.0; 95.1; -0.5; -47.9; 2.5; -43.9 | — |
| SECONDARY Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52 |
44.0; 45.1; -0.6; -11.4; -1.2; -10.6 | — |
| SECONDARY Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52 |
48.7; 49.0; 0.4; 2.9; -0.0; 3.3 | — |
| SECONDARY Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 |
4.0; 4.1; -0.0; -1.6; 0.1; -1.5 | — |
| SECONDARY Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 |
0.7; 0.7; 0.0; -0.3; 0.0; -0.3 | — |
| SECONDARY Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Litre) at Week 12, 24 and 52 |
41.5; 87.5; 37.3; 82.1; 36.9; 77.3 | — |
| SECONDARY Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Litre) at Week 12, 24 and 52 |
5.5; 76.8; 3.3; 69.6; 6.4; 61.7 | — |
| SECONDARY Plasma PF-04950615 Concentrations at Week 12, 24 and 52 |
5.53; 5.36; 4.07 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions |
2; 1; 5; 42 | — |
| SECONDARY Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) |
44; 27 | — |
Summary
This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.
Eligibility Criteria
Inclusion Criteria
- Treated with a statin.
- Fasting LDL-C > 70 mg/dL and triglyceride <=400 mg/dL.
- High or very high risk of incurring a cardiovascular event.
Exclusion Criteria
- Pregnant or breastfeeding females.
- Cardiovascular or cerebrovascular event of procedures during the past 30 days.
- Congestive heart failure NYHA class IV.
- Poorly controlled hypertension.
Data sourced from ClinicalTrials.gov (NCT01968954). 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.