Effect of Alirocumab on Lipid Metabolism in Adults With Elevated LDL-Cholesterol
Completed · Phase 1 · Has a placebo group
Conditions studied: Hypercholesterolemia
In brief
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.
Key facts
- Study ID
- NCT01959971
- Run by
- Sanofi
- People needed
- 20
- Starts
- 2013-12-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2017-05-02
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Generally healthy; LDL-C level in serum or plasma ≥ 100 mg/dL and < 190 mg/dL at Screening.
You may not qualify if…
- LDL-C ≥ 160 mg/dL at Screening if more than 2 major Coronary Heart Disease risk factors, as defined in National Cholesterol Education Program guidelines.
- Receiving treatment of any kind for hyperlipidemia within 6 weeks of enrollment.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Where it is running
- Investigational Site Number 840001 — New York, New York, United States
Full record on ClinicalTrials.gov
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