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

Phase 1

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: alirocumab; Drug: Placebo

• Registration Number: NCT01959971
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-10-07
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-10
• Study Start: 2013-12
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo - Alirocumab	alirocumab	Injection through subcutaneous (SC) administration, placebo for 4 weeks then, alirocumab for 10 weeks
Placebo - Alirocumab	Placebo	Injection through subcutaneous (SC) administration, placebo for 4 weeks then, alirocumab for 10 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in post-heparin hepatic lipase and lipoprotein lipase activities	baseline and at 2 days after last dose of alirocumab
Assessment of the serum concentration of anti-alirocumab antibodies	baseline and up to 10 weeks after last dose of alirocumab
Assessment of serum concentrations of PCSK9	baseline and up to 2 weeks after last dose of alirocumab
Assessment of the serum concentration of alirocumab	baseline and up to 2 weeks after last dose of alirocumab
Change in lipids turnover parameters measured in isolated Very Low Density Lipoproteins (VLDL), Intermediate Density Lipoproteins (IDL), Low Density Lipoproteins (LDL) and High Density Lipoproteins (HDL)	baseline and at 12 days after last dose of alirocumab
Change in lipids and apolipoproteins in plasma lipids panel	baseline and at 2 days and at 11 days after last dose of alirocumab
Assessment of Lipoprotein particle size profiles	baseline and at 2 days and at 11 days after last dose of alirocumab
Assessment of safety parameters (clinical laboratory, ECG, vital signs)	up to 10 weeks after last dose of alirocumab

Trial Locations

Locations (1)

Investigational Site Number 840001; 🇺🇸 New York, New York, United States