Phase 3
Completed N=184
Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins
Source: ClinicalTrials.gov NCT02135029 ↗Enrolled (actual)
184
Serious AEs
8.7%
Results posted
Dec 2017
Primary outcomePrimary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 — 2.4; -52.0; -32.6 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, double blinded, active and placebo controlled randomized clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615; RN316) compared to placebo in subjects who are statin intolerant.
Linked Publications (2)
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Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab.
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Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 |
2.4; -52.0; -32.6 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24 |
1.3; -37.0; -25.7; -0.5; -31.2; -26.8 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24 |
0.9; -46.0; -27.2; 0.1; -39.1; -28.1 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24 |
1.1; -50.0; -32.5; -0.3; -41.9; -34.0 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24 |
2.0; -21.5; 5.1; 0.8; -16.6; 4.1 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24 |
0.4; 13.2; 0.4; -0.3; 11.5; 0.2 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 |
1.6; -42.7; -33.3 | — |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24 |
2.2; -12.5; -20.7; -3.3; -13.6; -21.9 | — |
| SECONDARY Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24 |
1.9; 8.0; -2.8; 2.3; 8.0; -2.2 | — |
| SECONDARY Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24 |
-0.4; 4.1; -3.2; -2.2; 3.9; -0.6 | — |
| SECONDARY Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24 |
2.2; -12.5; -20.7; -3.3; -13.6; -21.9 | — |
| SECONDARY Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 |
182.1; 168.8; 169.9; 3.1; -88.0; -56.5 | — |
| SECONDARY Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 |
262.3; 250.1; 256.2; 3.2; -93.8; -67.7 | — |
| SECONDARY Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12 |
51.6; 51.1; 55.7; 0.1; 6.0; -0.5 | — |
| SECONDARY Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 |
210.7; 199.2; 200.5; 2.2; -99.8; -67.1 | — |
| SECONDARY Absolute Change From Baseline in Fasting Triglycerides (TG) at Week 12 |
— | — |
| SECONDARY Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 |
133.3; 125.8; 124.6; 1.1; -57.5; -35.3 | — |
| SECONDARY Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12 |
32.0; 27.1; 31.7; 0.7; -5.8; 1.9 | — |
| SECONDARY Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24 |
5.4; 5.2; 4.8; 0.1; -2.3; -1.3 | — |
| SECONDARY Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24 |
0.9; 0.9; 0.8; -0.0; -0.4; -0.2 | — |
| SECONDARY 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 |
1.4; 71.8; 42.9; 0; 61.4; 45.5 | — |
| SECONDARY 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 |
0; 45.1; 14.3; 0; 41.4; 15.2 | — |
| SECONDARY Plasma PF-04950615 Concentrations at Weeks 12 and 24 |
10.21; 7.38 | — |
| SECONDARY 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 |
1; 0; 0; 4; 16; 0 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb) |
35; 21 | — |
| SECONDARY Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively |
9.94; 9.49; 9.46; 10.12; 6.05; 5.28 | — |
| SECONDARY Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations |
9.6; 10.8; 16.7; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Hyperlipidemia
- Statin Intolerant
- Fasting LDL-C > = 70 mg/dL Fasting TG < = 400 mg/dL
Exclusion Criteria
- Pregnant or breastfeeding females
- Cardiovascular or cerebrovascular event or procedure within 90 days
- Severe or life-threatening adverse events with past use of statins
- Poorly controlled hypertension
Data sourced from ClinicalTrials.gov (NCT02135029) 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.