Hypercholesterolemia Clinical Trial
Official title:
A Phase 1 Study of the Effects of Subcutaneous Doses of Alirocumab on Lipid and Lipoprotein Metabolism in Adults With Mildly Elevated LDL-Cholesterol
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.
Total duration of the study per subject is 26 weeks, including a screening period of ≤ 4 weeks, placebo treatment period of 4 weeks, alirocumab treatment period of 10 weeks, and a follow up period of 8 weeks. ;
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