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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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ClinicalTrials.gov Identifier: NCT01723735
Recruitment Status : Completed
First Posted : November 8, 2012
Last Update Posted : September 28, 2016
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Alirocumab Drug: Ezetimibe Drug: Ezetimibe Placebo Drug: Fenofibrate Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : November 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013


Arm Intervention/treatment
Experimental: Alirocumab + Ezetimibe Placebo
Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe placebo
Drug: Alirocumab

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Names:
  • SAR236553
  • REGN727
Drug: Ezetimibe Placebo

Pharmaceutical form: capsule

Route of administration: oral

Experimental: Alirocumab + Ezetimibe
Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe
Drug: Alirocumab

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Names:
  • SAR236553
  • REGN727
Drug: Ezetimibe

Pharmaceutical form: overencapsulated tablet

Route of administration: oral

Experimental: Alirocumab + Fenofibrate
Subcutaneous (SC) injections of alirocumab added to oral administration of fenofibrate
Drug: Alirocumab

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Names:
  • SAR236553
  • REGN727
Drug: Fenofibrate

Pharmaceutical form: tablet

Route of administration: oral




Primary Outcome Measures :
  1. Assessment of the effect of alirocumab on LDL-C [ Time Frame: Up to 18 weeks ]

Secondary Outcome Measures :
  1. Assessment of the pharmacodynamic profile of alirocumab [ Time Frame: Up to 18 weeks ]
  2. Pharmacokinetics: Assessment of serum concentrations of alirocumab [ Time Frame: Up to 18 weeks ]
  3. Pharmacokinetics: Assessment of serum concentrations of proprotein convertase subtilisin kexin type 9 (PCSK9) [ Time Frame: Up to 18 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723735


Locations
France
Investigational Site Number 250001
Rennes, France, 35000
Investigational Site Number 250002
Rueil Malmaison, France, 92502
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Publications of Results:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01723735     History of Changes
Other Study ID Numbers: PKD12910
U1111-1131-3203 ( Other Identifier: UTN )
2012-003049-13 ( EudraCT Number )
First Posted: November 8, 2012    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Fenofibrate
Antibodies, Monoclonal
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Immunologic Factors
Physiological Effects of Drugs