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 has been completed.
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: July 16, 2012
Last updated: February 9, 2015
Last verified: February 2015

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

Primary Objective of the study:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab 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 in comparison with placebo on LDL-C at other time points.
  • To evaluate the effect of alirocumab on other lipid parameters.
  • To evaluate the safety and tolerability of alirocumab.

Condition Intervention Phase
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 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 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 Week 52 [ Time Frame: From baseline to Week 52 ] [ Designated as safety issue: No ]
  • Percent change in other lipid parameters at Week 12, Week 24 and Week 52 [ Time Frame: From baseline to Week 52 ] [ Designated as safety issue: No ]

Enrollment: 316
Study Start Date: July 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alirocumab
Injection through subcutaneous (SC) administration
Drug: Alirocumab

Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous

Other Names:
  • SAR236553
  • REGN727
Placebo Comparator: Placebo
Injection through subcutaneous (SC) administration
Drug: 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.


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

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

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Sponsors and Collaborators
Regeneron Pharmaceuticals
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: NCT01644175     History of Changes
Other Study ID Numbers: EFC11568, U1111-1121-4356
Study First Received: July 16, 2012
Last Updated: February 9, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 09, 2015