Effect of Alirocumab on Lipid Metabolism in Adults With Elevated LDL-Cholesterol

Part of paid clinical trials in New York, New York.

Sponsor
Sanofi
Study ID
NCT01959971
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • alirocumab — DRUG
    Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
  • Placebo — DRUG
    Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

Study Details

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 Dates

Start date
Dec 31, 2013
Status verified
Apr 2017
Primary completion
May 31, 2015
Completion
May 31, 2015

Study Design

Enrollment
20 participants (actual)
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Placebo - Alirocumab
    Injection through subcutaneous (SC) administration, placebo for 4 weeks then, alirocumab for 10 weeks

Primary Outcome Measure

Percent change in Fractional Clearance Rate of apolipoprotein B (apoB) in Low Density Lipoproteins (pools/day) in plasma during alirocumab treatment [ Time Frame: baseline and at 12 days after last dose of alirocumab ]

Locations (1)

FacilityCityStateZIPSite coordinators
Investigational Site Number 840001New YorkNew York10032-

Find similar trials in New York, NY

By research site
Investigational· New York, NY

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