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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01723735

Enrollment

Registered

2012-11-08

Start date

2012-11-30

Completion date

2013-07-31

Last updated

2016-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Brief summary

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.

Detailed description

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

Interventions

DRUGEzetimibe

Pharmaceutical form: overencapsulated tablet Route of administration: oral

DRUGAlirocumab

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUGEzetimibe Placebo

Pharmaceutical form: capsule Route of administration: oral

DRUGFenofibrate

Pharmaceutical form: tablet Route of administration: oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Assessment of the effect of alirocumab on LDL-C	Up to 18 weeks

Secondary

Measure	Time frame
Assessment of the pharmacodynamic profile of alirocumab	Up to 18 weeks
Pharmacokinetics: Assessment of serum concentrations of alirocumab	Up to 18 weeks
Pharmacokinetics: Assessment of serum concentrations of proprotein convertase subtilisin kexin type 9 (PCSK9)	Up to 18 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026