NCT01723735

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

September 28, 2016

Status Verified

September 1, 2016

Enrollment Period

8 months

First QC Date

November 6, 2012

Last Update Submit

September 27, 2016

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Assessment of the effect of alirocumab on LDL-C

    Up to 18 weeks

Secondary Outcomes (3)

  • 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

Study Arms (3)

Alirocumab + Ezetimibe Placebo

EXPERIMENTAL

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

Drug: AlirocumabDrug: Ezetimibe Placebo

Alirocumab + Ezetimibe

EXPERIMENTAL

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

Drug: AlirocumabDrug: Ezetimibe

Alirocumab + Fenofibrate

EXPERIMENTAL

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

Drug: AlirocumabDrug: Fenofibrate

Interventions

AlirocumabDRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Also known as: SAR236553, REGN727
Alirocumab + EzetimibeAlirocumab + Ezetimibe PlaceboAlirocumab + Fenofibrate
EzetimibeDRUG

Pharmaceutical form: overencapsulated tablet Route of administration: oral

Alirocumab + Ezetimibe
Ezetimibe PlaceboDRUG

Pharmaceutical form: capsule Route of administration: oral

Alirocumab + Ezetimibe Placebo
FenofibrateDRUG

Pharmaceutical form: tablet Route of administration: oral

Alirocumab + Fenofibrate

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Investigational Site Number 250001

Rennes, 35000, France

Location

Investigational Site Number 250002

Rueil-Malmaison, 92502, France

Location

Related Publications (1)

  • 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.

    PMID: 27287699RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

alirocumabEzetimibeFenofibrate

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetones

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2012

First Posted

November 8, 2012

Study Start

November 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

September 28, 2016

Record last verified: 2016-09

Locations

FR(2)