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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypercholesterolemia

Study Design

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Intervention Model

CROSSOVER

Single-sequence crossover

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo - Alirocumab

Injection through subcutaneous (SC) administration, placebo for 4 weeks then, alirocumab for 10 weeks

Group Type EXPERIMENTAL

alirocumab

Intervention Type DRUG

Pharmaceutical form:Solution for injection

Route of administration: Subcutaneous

Placebo

Intervention Type DRUG

Pharmaceutical form:Solution for injection

Route of administration: Subcutaneous

Interventions

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alirocumab

Pharmaceutical form:Solution for injection

Route of administration: Subcutaneous

Intervention Type DRUG

Placebo

Pharmaceutical form:Solution for injection

Route of administration: Subcutaneous

Intervention Type DRUG

Other Intervention Names

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SAR236553 REGN727 Praluent

Eligibility Criteria

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Inclusion Criteria

Generally healthy; LDL-C level in serum or plasma ≥ 100 mg/dL and \< 190 mg/dL at Screening.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes