Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody

Double-blind, Randomized, Placebo-controlled, Single Site Study to Evaluate the Effects of Evolocumab (AMG 145) Treatment, Alone and in Combination With Atorvastatin, on Lipoprotein Kinetics

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

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