Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY High FH)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01617655
First received: June 8, 2012
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.

Secondary Objectives:

  • To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points.
  • To evaluate the effects of alirocumab on other lipid parameters.
  • To evaluate the safety and tolerability of alirocumab.

Condition Intervention Phase
Hypercholesterolaemia
Drug: Alirocumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia and LDL-C Higher or Equal to 160mg/dL With Their Lipid-Modifying Therapy

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percent change in calculated LDL-C at Week 24 [ Time Frame: From baseline to Week 52 ] [ Designated as safety issue: No ]
    From a mixed-effect model including all LDL-C values collected up to Week 52


Secondary Outcome Measures:
  • Percent change in calculated LDL-C at Week 12 and 52 [ Time Frame: From baseline up to Week 52 ] [ Designated as safety issue: No ]
  • Percent change in other lipid parameters at Week 12, Week 24 and 52 [ Time Frame: From baseline up to Week 52 ] [ Designated as safety issue: No ]
  • Percent change in calculated LDL-C at Week 78 [ Time Frame: From baseline up to Week 78 ] [ Designated as safety issue: No ]
    From a mixed-effect model including all LDL-C values collected up to Week 78

  • Percent change in other lipid parameters at Week 78 [ Time Frame: From baseline up to Week 78 ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: June 2012
Estimated Study Completion Date: January 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alirocumab

Injection through subcutaneous (SC) administration.

Background statin therapy or other lipid lowering therapy will be administered according to site investigator discretion as background therapy.

Drug: Alirocumab

Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous

Other Names:
  • SAR236553
  • REGN727
Placebo Comparator: Placebo

Injection through subcutaneous (SC) administration.

Background statin therapy or other lipid lowering therapy will be administered according to site investigator discretion as background therapy.

Drug: Placebo

Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous


Detailed Description:

The maximum study duration will be 89 weeks per patient, including a 78-week randomized treatment period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with heterozygous familial hypercholesterolemia who are not adequately controlled with their lipid-modifying therapy.

Exclusion criteria:

  • Age < 18 years
  • LDL-C < 160 mg/dL (< 4.14 mmol/L) at the screening visit (Week-3).
  • Fasting serum triglycerides > 400 mg/dL (> 4.52 mmol/L) during the screening period.
  • Known history of homozygous familial hypercholesterolemia.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617655

  Hide Study Locations
Locations
United States, California
Investigational Site Number 840742
Bell Gardens, California, United States, 90201
Investigational Site Number 840703
Newport Beach, California, United States, 92660
Investigational Site Number 840712
Newport Beach, California, United States, 92663
Investigational Site Number 840743
Northridge, California, United States, 91324
United States, District of Columbia
Investigational Site Number 840734
Washington, District of Columbia, United States, 20037
United States, Florida
Investigational Site Number 840738
Miami, Florida, United States, 33165
Investigational Site Number 840710
Ponte Vedra, Florida, United States, 32081
United States, New York
Investigational Site Number 840701
New York, New York, United States, 10032
United States, North Carolina
Investigational Site Number 840702
Durham, North Carolina, United States, 27710
United States, Ohio
Investigational Site Number 840714
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
Investigational Site Number 840709
Philadelphia, Pennsylvania, United States, 19104
Investigational Site Number 840705
Philadelphia, Pennsylvania, United States, 19104
Investigational Site Number 840713
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Investigational Site Number 840736
Dallas, Texas, United States, 75216
Canada
Investigational Site Number 124704
Quebec, Canada, G1V 4M6
Investigational Site Number 124703
Sherbrooke, Canada, J1H 5N4
Netherlands
Investigational Site Number 528713
Amsterdam, Netherlands, 1091 AC
Investigational Site Number 528701
Amsterdam, Netherlands, 1105 AZ
Investigational Site Number 528704
Groningen, Netherlands, 9728 NT
Investigational Site Number 528716
Leiden, Netherlands, 2333 ZA
Investigational Site Number 528709
Utrecht, Netherlands, 3582 KE
Russian Federation
Investigational Site Number 643706
Arkhangelsk, Russian Federation, 163000
Investigational Site Number 643705
Kazan, Russian Federation, 420012
Investigational Site Number 643703
Moscow, Russian Federation, 111539
Investigational Site Number 643711
Moscow, Russian Federation, 121552
Investigational Site Number 643708
Moscow, Russian Federation, 129301
Investigational Site Number 643702
Saint Petersburg, Russian Federation, 197341
Investigational Site Number 643710
St-Petersburg, Russian Federation, 193079
Investigational Site Number 643709
St-Petersburg, Russian Federation, 194291
Investigational Site Number 643707
Yaroslavl, Russian Federation, 150062
South Africa
Investigational Site Number 710704
Bloemfontein, South Africa, 9301
Investigational Site Number 710701
Bloemfontein, South Africa, 9301
Investigational Site Number 710706
Cap Town, South Africa, 7530
Investigational Site Number 710702
Parktown, South Africa, 2193
Investigational Site Number 710703
Somerset West, South Africa, 7130
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01617655     History of Changes
Other Study ID Numbers: EFC12732, U1111-1128-5459, 2012-001096-37
Study First Received: June 8, 2012
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Dyslipidemias
Genetic Diseases, Inborn
Hyperlipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Metabolic Diseases
Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on October 20, 2014