Effect of Alirocumab on Lipid Metabolism in Adults With Elevated LDL-Cholesterol
Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
To assess the effects of subcutaneous (SC) doses of alirocumab on the elimination (measured
by Fractional Clearance Rate (FCR)) of apolipoprotein B (apoB) in low density lipoprotein
(LDL) in adults with mildly elevated LDL-cholesterol (LDL-C).
Secondary Objectives:
To assess the effects of SC doses of alirocumab on:
- Various parameters of the metabolism and turnover in plasma of different lipoproteins
- Plasma lipids concentration: total cholesterol, high density lipoprotein cholesterol
(HDL-C), triglycerides, low density lipoprotein cholesterol (LDL-C), apoB,
lipoprotein(a) (Lp(a))
- Lipoprotein particle size profile
- PCSK9 (free and total) concentrations in serum To assess safety and tolerability of
alirocumab. To assess emergence of anti-alirocumab antibodies. To document serum
alirocumab concentrations.