Phase 3
N=746
Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events
Hyperlipidemia
Bottom Line
View on ClinicalTrials.gov: NCT02100514 ↗Enrolled (actual)
746
Serious AEs
9.0%
Results posted
Jul 2017
Primary outcome: Primary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 — -0.8; -50.8 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
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 |
-0.8; -50.8 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52 |
-2.2; -35.4; -3.1; -32.9; -5.0; -29.0 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52 |
-0.6; -46.5; -2.1; -43.5; -4.4; -37.3 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12, 24 and 52 |
-2.6; -47.6; -3.8; -44.7; -6.4; -39.5 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 |
0.5; -51.1; -1.6; -48.4; -4.2; -42.2 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 |
-5.7; -45.8; -5.7; -40.9 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12, 24 and 52 |
4.9; -25.7; 5.9; -21.3; 27.9; -21.5 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52 |
0.6; 6.3; 0.6; 6.3; 0.7; 7.0 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period |
-2.9; -47.5; -4.7; -41.8 | — |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52 |
-6.2; -16.2; -8.9; -18.2; -8.0; -15.8 | — |
| SECONDARY Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 |
-0.9; 3.4; -1.6; 2.5; -1.0; 3.4 | — |
| SECONDARY Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52 |
2.0; 3.0; 2.6; 3.7; 0.7; 1.9 | — |
| SECONDARY Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52 |
-6.2; -16.2; -8.9; -18.2; -8.0; -15.8 | — |
| SECONDARY Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12 |
130.1; 130.2; -0.5; -67.3 | — |
| SECONDARY Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12 |
143.7; 147.2; -6.6; -74.1 | — |
| SECONDARY Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 |
134.7; 135.9; -2.5; -69.6 | — |
| SECONDARY Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 |
209.4; 210.3; -5.9; -75.4 | — |
| SECONDARY Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 |
160.2; 162.1; -5.8; -77.9 | — |
| SECONDARY Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12 |
106.1; 107.1; -1.6; -49.8 | — |
| SECONDARY Absolute Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12 |
48.5; 47.3; 0.1; -10.3 | — |
| SECONDARY Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12 |
49.2; 48.3; -0.1; 2.5 | — |
| SECONDARY Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52 |
4.6; 4.6; -0.2; -1.8; -0.2; -1.6 | — |
| SECONDARY Absolute Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 |
0.7; 0.8; 0.0; -0.4; -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 (mg/dL) at Week 12, 24 and 52 |
10.2; 81.6; 19.9; 75.1; 25.2; 72.7 | — |
| SECONDARY Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 |
1.3; 62.2; 1.7; 60.1; 3.2; 53.4 | — |
| SECONDARY Plasma Concentration Versus Time Summary of PF-04950615 |
5.37; 5.28; 4.01 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) Related to Type 1 and 3 Hypersensitivity Reactions and Injection Site Reactions |
0.0; 0.2; 0.8; 13.4 | — |
| SECONDARY Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period |
54.8; 37.9 | — |
| SECONDARY Number of Participants Who Changed Concomitant Medication During Extension Period |
2; 4; 3 | — |
| SECONDARY Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (Follow up), 71, 84, 97 and 110: Extension Period |
6.7; 8.7; 7.0; 2.6; 15.5 | — |
| SECONDARY Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period |
100.0; 60.6; 87.1; 35.5; 82.1; 25.0 | — |
Summary
This study is a multicenter, double-blind, randomized study to access the efficacy, safety and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia receiving background statin therapy.
Eligibility Criteria
Inclusion Criteria
- Treated with a statin
- Fasting LDL-C >=100 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 or procedure within 90 days
- Congestive heart failure NYHA class IV
- Poorly controlled hypertension
Data sourced from ClinicalTrials.gov (NCT02100514). 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.