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Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins

Phase 3
Completed
Conditions
Hyperlipidemia
Interventions
Other: Placebo for Bococizumab (PF-04950615;RN316)
Other: Placebo for atorvastatin
Registration Number
NCT02135029
Lead Sponsor
Pfizer
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
184
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Bococizumab (PF-04950615;RN316)Bococizumab (PF-04950615;RN316)Bococizumab (PF-04950615;RN316)
AtorvastatinAtorvastatin-
PlaceboPlacebo for Bococizumab (PF-04950615;RN316)-
PlaceboPlacebo for atorvastatin-
Primary Outcome Measures
NameTimeMethod
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12Baseline, Week 12
Secondary Outcome Measures
NameTimeMethod
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24Baseline, Week 12, 24
Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24Baseline, Week 12, 24
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24Baseline, Week 12, 24
Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24Baseline, Week 12, 24
Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24Baseline, Week 12, 24
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24Baseline, Week 24
Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24Baseline, Week 12, 24
Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24Baseline, Week 12, 24
Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24Baseline, Week 12, 24
Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24Baseline, Week 12, 24
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12Baseline, Week 12
Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12Baseline, Week 12
Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12Baseline, Week 12
Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12Baseline, Week 12
Absolute Change From Baseline in Fasting Triglycerides (TG) at Week 12Baseline, Week 12
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12Baseline, Week 12
Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12Baseline, Week 12
Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24Baseline, Week 12, 24
Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24Baseline, Week 12, 24
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 24Week 12, 24
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 24Week 12, 24
Plasma PF-04950615 Concentrations at Weeks 12 and 24Week 12 and 24

Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.4 micrograms per milliliter \[mcg/mL\]) to zero. Participants who received PF-04950615 150 mg were evaluable for this outcome measure.

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) ElevationsBaseline (Day 1) up to Week 30
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb)Baseline up to Week 30

Participants with at least one positive ADA titer greater than or equal to (\>=) 6.23 or positive nAb titer \>=4.32 were reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint.

Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb RespectivelyWeek 4, 12, 24 and 30 (Follow-up)

Titer levels of participants who tested positive for ADA and nAb are reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint.

Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) ElevationsBaseline (Day 1) up to Week 30

Trial Locations

Locations (40)

Creekside Endocrine Associates, PC

🇺🇸

Denver, Colorado, United States

Bridgeport Hospital

🇺🇸

Bridgeport, Connecticut, United States

Watson Clinic Center for Research, Inc. (for Drug Shipment only)

🇺🇸

Lakeland, Florida, United States

Cardiovascular Research Center Of South Florida

🇺🇸

Miami, Florida, United States

St. Johns Center for Clinical Research

🇺🇸

Ponte Vedra, Florida, United States

Progressive Medical Research

🇺🇸

Port Orange, Florida, United States

East-West Medical Research Institute

🇺🇸

Honolulu, Hawaii, United States

NorthShore University HealthSystem - Evanston Hospital

🇺🇸

Evanston, Illinois, United States

Health Care Centers of Illinois Mokena Medical Commons

🇺🇸

Mokena, Illinois, United States

Advocate Medical Group Cardiology

🇺🇸

Normal, Illinois, United States

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Creekside Endocrine Associates, PC
🇺🇸Denver, Colorado, United States

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