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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Hypercholesterolemia

Treatments: Drug: Ezetimibe; Drug: Ezetimibe Placebo; Drug: Alirocumab; Drug: Fenofibrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01723735

U1111-1131-3203 (Other Identifier)

2012-003049-13 (EudraCT Number)

PKD12910

Details and patient eligibility

About

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.

Full description

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

Enrollment: 79 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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79 participants in 3 patient groups

Alirocumab + Ezetimibe Placebo

Experimental group

Description:

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

Treatment:

Drug: Alirocumab

Drug: Ezetimibe Placebo

Alirocumab + Ezetimibe

Experimental group

Description:

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

Treatment:

Drug: Ezetimibe

Drug: Alirocumab

Alirocumab + Fenofibrate

Experimental group

Description:

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

Treatment:

Drug: Alirocumab

Drug: Fenofibrate