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

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

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-07-31

Brief Summary

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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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Detailed Description

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

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Alirocumab + Ezetimibe Placebo

Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe placebo

Group Type EXPERIMENTAL

Alirocumab

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Ezetimibe Placebo

Intervention Type DRUG

Pharmaceutical form: capsule

Route of administration: oral

Alirocumab + Ezetimibe

Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe

Group Type EXPERIMENTAL

Alirocumab

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Ezetimibe

Intervention Type DRUG

Pharmaceutical form: overencapsulated tablet

Route of administration: oral

Alirocumab + Fenofibrate

Subcutaneous (SC) injections of alirocumab added to oral administration of fenofibrate

Group Type EXPERIMENTAL

Alirocumab

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Fenofibrate

Intervention Type DRUG

Pharmaceutical form: tablet

Route of administration: oral

Interventions

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Alirocumab

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Intervention Type DRUG

Ezetimibe

Pharmaceutical form: overencapsulated tablet

Route of administration: oral

Intervention Type DRUG

Ezetimibe Placebo

Pharmaceutical form: capsule

Route of administration: oral

Intervention Type DRUG

Fenofibrate

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type DRUG

Other Intervention Names

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SAR236553 REGN727

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes