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

Pfizer184 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

184

Conditions

Hyperlipidemia

Interventions

Bococizumab (PF-04950615;RN316)DRUG

150 mg every 2 weeks by subcutaneous injection for 24 weeks

AtorvastatinDRUG

Atorvastatin PO QD

Placebo for Bococizumab (PF-04950615;RN316)OTHER

150 mg every 2 weeks by subcutaneous injection for 24 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (40)

Outcomes

Primary Outcomes

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Time frame: Baseline, Week 12

Secondary Outcomes

Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24

Time frame: Baseline, Week 12, 24

Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24

Time frame: Baseline, Week 12, 24

Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24

Time frame: Baseline, Week 12, 24

Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24

Time frame: Baseline, Week 12, 24

Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24

Time frame: Baseline, Week 12, 24

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24

Time frame: Baseline, Week 24

Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24

Time frame: Baseline, Week 12, 24

Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24

Time frame: Baseline, Week 12, 24

Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24

Data from ClinicalTrials.gov

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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

...and 30 more locations

Time frame: Baseline, Week 12, 24

Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24

Time frame: Baseline, Week 12, 24

Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Time frame: Baseline, Week 12

Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12

Time frame: Baseline, Week 12

Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12

Time frame: Baseline, Week 12

Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12

Time frame: Baseline, Week 12

Absolute Change From Baseline in Fasting Triglycerides (TG) at Week 12

Time frame: Baseline, Week 12

Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12

Time frame: Baseline, Week 12

Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12

Time frame: Baseline, Week 12

Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24

Time frame: Baseline, Week 12, 24

Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24

Time frame: Baseline, 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 24

Time frame: Week 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 24

Time frame: Week 12, 24

Plasma PF-04950615 Concentrations at Weeks 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.

Time frame: Week 12 and 24

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

Time frame: Baseline (Day 1) up to Week 30

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb)

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.

Time frame: Baseline up to Week 30

Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively

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

Time frame: Week 4, 12, 24 and 30 (Follow-up)

Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations

Time frame: Baseline (Day 1) up to Week 30