Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody

• Status: Completed
• Trial end date: 2015-03-05
• Target enrollment: 0
• Participant gender: Male

Summary

This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Atorvastatin; Atorvastatin Calcium; Evolocumab

Criteria

Inclusion Criteria:

• Fasting LDL-C at screening ≥ 100 mg/dL and ≤ 190 mg/dL

• Fasting triglycerides ≤ 150 mg/dL

• Body mass index (BMI) between 18.0 and 32.0 kg/m^2

• Framingham cardiac risk score 10% or less

Exclusion Criteria:

• Treatment with a lipid-regulating drug or over the counter supplement in the last 3 months prior to screening

• History of coronary heart disease (CHD) or CHD equivalent

• Uncontrolled hypertension

• Diabetes mellitus