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Completed

NCT Number: NCT01959971

Effect of Alirocumab on Lipid Metabolism in Adults With 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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number 840001

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alirocumab

Drug

Pharmaceutical form:Solution for injection

Route of administration: Subcutaneous

Other names: SAR236553, REGN727, Praluent

Placebo

Drug

Pharmaceutical form:Solution for injection

Route of administration: Subcutaneous

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

    Time frame: baseline and at 12 days after last dose of alirocumab

  2. Change in post-heparin hepatic lipase and lipoprotein lipase activities

    Time frame: baseline and at 2 days after last dose of alirocumab

  3. Change in lipids and apolipoproteins in plasma lipids panel

    Time frame: baseline and at 2 days and at 11 days after last dose of alirocumab

  4. Assessment of Lipoprotein particle size profiles

    Time frame: baseline and at 2 days and at 11 days after last dose of alirocumab

  5. Assessment of serum concentrations of PCSK9

    Time frame: baseline and up to 2 weeks after last dose of alirocumab

  6. Assessment of safety parameters (clinical laboratory, ECG, vital signs)

    Time frame: up to 10 weeks after last dose of alirocumab

  7. Assessment of the serum concentration of alirocumab

    Time frame: baseline and up to 2 weeks after last dose of alirocumab

  8. Assessment of the serum concentration of anti-alirocumab antibodies

    Time frame: baseline and up to 10 weeks after last dose of alirocumab

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 10, 2013
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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