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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Alirocumab
Ezetimibe
Ezetimibe Placebo
Fenofibrate
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Investigational Site Number 250001
  • Investigational Site Number 250002

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Alirocumab + Ezetimibe Placebo

Alirocumab + Ezetimibe

Alirocumab + Fenofibrate

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Assessment of the effect of alirocumab on LDL-C

Secondary Outcome Measures

Assessment of the pharmacodynamic profile of alirocumab
Pharmacokinetics: Assessment of serum concentrations of alirocumab
Pharmacokinetics: Assessment of serum concentrations of proprotein convertase subtilisin kexin type 9 (PCSK9)

Full Information

First Posted
November 6, 2012
Last Updated
September 27, 2016
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01723735
Brief Title
Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alirocumab + Ezetimibe Placebo
Arm Type
Experimental
Arm Description
Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe placebo
Arm Title
Alirocumab + Ezetimibe
Arm Type
Experimental
Arm Description
Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe
Arm Title
Alirocumab + Fenofibrate
Arm Type
Experimental
Arm Description
Subcutaneous (SC) injections of alirocumab added to oral administration of fenofibrate
Intervention Type
Drug
Intervention Name(s)
Alirocumab
Other Intervention Name(s)
SAR236553, REGN727
Intervention Description
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Intervention Description
Pharmaceutical form: overencapsulated tablet Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Ezetimibe Placebo
Intervention Description
Pharmaceutical form: capsule Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Intervention Description
Pharmaceutical form: tablet Route of administration: oral
Primary Outcome Measure Information:
Title
Assessment of the effect of alirocumab on LDL-C
Time Frame
Up to 18 weeks
Secondary Outcome Measure Information:
Title
Assessment of the pharmacodynamic profile of alirocumab
Time Frame
Up to 18 weeks
Title
Pharmacokinetics: Assessment of serum concentrations of alirocumab
Time Frame
Up to 18 weeks
Title
Pharmacokinetics: Assessment of serum concentrations of proprotein convertase subtilisin kexin type 9 (PCSK9)
Time Frame
Up to 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 250001
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Investigational Site Number 250002
City
Rueil Malmaison
ZIP/Postal Code
92502
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27287699
Citation
Rey J, Poitiers F, Paehler T, Brunet A, DiCioccio AT, Cannon CP, Surks HK, Pinquier JL, Hanotin C, Sasiela WJ. Relationship Between Low-Density Lipoprotein Cholesterol, Free Proprotein Convertase Subtilisin/Kexin Type 9, and Alirocumab Levels After Different Lipid-Lowering Strategies. J Am Heart Assoc. 2016 Jun 10;5(6):e003323. doi: 10.1161/JAHA.116.003323.
Results Reference
result

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

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