Efficacy and Safety of Alirocumab SAR236553 (REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY Combo I)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01644175
First received: July 16, 2012
Last updated: July 18, 2013
Last verified: May 2013
  Purpose

Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab SAR236553 (REGN727) as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular (CV) risk patients with hypercholesterolemia.

Secondary Objectives:

  • To evaluate the effect of alirocumab SAR236553 (REGN727) in comparison with placebo on LDL-C at other time points.
  • To evaluate the effect of alirocumab SAR236553 (REGN727) on other lipid parameters.
  • To evaluate the safety and tolerability of alirocumab SAR236553 (REGN727).

Condition Intervention Phase
Hypercholesterolemia
Drug: alirocumab SAR236553 (REGN727)
Other: 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/REG727 in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percent change in LDL-C [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change in LDL-C [ Time Frame: From baseline to weeks 12 and 52 ] [ Designated as safety issue: No ]
  • Percent change in other lipid parameters [ Time Frame: From baseline to weeks 12, 24 and 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 306
Study Start Date: July 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alirocumab SAR236553 (REGN727)
Injection through subcutaneous (SC) administration
Drug: alirocumab SAR236553 (REGN727)

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

Pharmaceutical form:Solution for injection Route of administration: subcutaneous

Placebo Comparator: Placebo
Injection through subcutaneous (SC) administration
Other: Placebo
Pharmaceutical form:Solution for injection Route of administration: subcutaneous

Detailed Description:

The maximum study duration will be 63 weeks per patient, including a 3 week screening period, 52 week randomized treatment period, and 8 week follow-up period.

  Eligibility

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

Inclusion criteria:

Patients with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin with or without other LMT, both at stable dose for at least 4 weeks to 6 weeks prior to screening (Week -2).

Exclusion criteria:

  • Age < 18 or legal age of adulthood, whichever is greater.
  • Patients without established CHD or CHD risk equivalent.
  • LDL-C <70 mg/dL (<1.81 mmol/L) and patients with a history of documented cardiovascular disease.
  • LDL-C <100 mg/dL (<2.59 mmol/L) and patients without a history of documented cardiovascular disease.
  • Not on a stable dose of LMT (including statin) for at least 4 Weeks and/or fenofibrate for at least 6 weeks, as applicable, prior to the screening visit (Week -2) and from screening to randomization.
  • Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L).

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01644175

  Show 83 Study Locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01644175     History of Changes
Other Study ID Numbers: EFC11568, U1111-1121-4356
Study First Received: July 16, 2012
Last Updated: July 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 15, 2014