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OpenTrials
Completed

NCT Number: NCT01723735

Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects

Primary Objective:

To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol (LDL-C).

Secondary Objectives:

* To assess the pharmacodynamic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate, based on other lipid parameters. * To assess the pharmacokinetic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate.

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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 250001, Rennes, France

Loading trial locations.

About this study

Total duration of the study per subject (excluding screening) is about 22 weeks.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male /or female subjects,
  • aged 18 to 65 years old,
  • with LDL-C > 130 mg/dL
  • not receiving lipid lowering therapy.

Exclusion criteria

  • Healthy subjects with history or presence of clinically relevant illness.
  • Subjects currently taking statins, ezetimibe or fenofibrate.
  • 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

ezetimibe

Drug

Pharmaceutical form: overencapsulated tablet

Route of administration: oral

Ezetimibe Placebo

Drug

Pharmaceutical form: capsule

Route of administration: oral

fenofibrate

Drug

Pharmaceutical form: tablet

Route of administration: oral

Primary outcomes

  1. Assessment of the effect of alirocumab on LDL-C

    Time frame: Up to 18 weeks

Secondary outcomes

  1. Assessment of the pharmacodynamic profile of alirocumab

    Time frame: Up to 18 weeks

  2. Pharmacokinetics: Assessment of serum concentrations of alirocumab

    Time frame: Up to 18 weeks

  3. Pharmacokinetics: Assessment of serum concentrations of proprotein convertase subtilisin kexin type 9 (PCSK9)

    Time frame: Up to 18 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

A Randomized, Partial Blind, 3 Parallel Groups Study of the Pharmacodynamic Profile of SAR236553 (REGN727) Administered as Multiple Subcutaneous Doses, Either Alone or on Top of Ezetimibe or Fenofibrate Administered as Multiple Oral Doses in Healthy Subjects

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 8, 2012
Registry last updated
Sep 28, 2016

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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