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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)

NCT ID: NCT01644175

Last Updated: 2015-11-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-04-30

Brief Summary

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

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 participants 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

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Detailed Description

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The maximum study duration was 62 weeks per participant, including a 2-week screening period, 52-week randomized treatment period, and 8-week follow-up period.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo Q2W

Placebo (for alirocumab) every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 52 weeks.

Group Type PLACEBO_COMPARATOR

Placebo (for alirocumab)

Intervention Type DRUG

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector (also known as pre-filled pen).

Lipid-Modifying Therapy (LMT)

Intervention Type DRUG

Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.

Alirocumab

Alirocumab 75 mg Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.

Group Type EXPERIMENTAL

Alirocumab

Intervention Type DRUG

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector (also known as pre-filled pen).

Lipid-Modifying Therapy (LMT)

Intervention Type DRUG

Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.

Interventions

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Placebo (for alirocumab)

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector (also known as pre-filled pen).

Intervention Type DRUG

Alirocumab

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector (also known as pre-filled pen).

Intervention Type DRUG

Lipid-Modifying Therapy (LMT)

Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.

Intervention Type DRUG

Other Intervention Names

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SAR236553 REGN727

Eligibility Criteria

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Inclusion Criteria

* Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who were 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 was greater
* Participants without established CHD or CHD risk equivalent
* LDL-C \<70 mg/dL (\<1.81 mmol/L) and participants with a history of documented cardiovascular disease
* LDL-C \<100 mg/dL (\<2.59 mmol/L) and participants 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 participant's potential participation in a clinical trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 840857

Birmingham, Alabama, United States

Site Status

Investigational Site Number 840891

Mobile, Alabama, United States

Site Status

Investigational Site Number 840876

Montgomery, Alabama, United States

Site Status

Investigational Site Number 840865

Glendale, Arizona, United States

Site Status

Investigational Site Number 840826

Jonesboro, Arkansas, United States

Site Status

Investigational Site Number 840870

Burbank, California, United States

Site Status

Investigational Site Number 840851

Los Angeles, California, United States

Site Status

Investigational Site Number 840845

Los Gatos, California, United States

Site Status

Investigational Site Number 840844

Sacramento, California, United States

Site Status

Investigational Site Number 840801

San Jose, California, United States

Site Status

Investigational Site Number 840886

Tarzana, California, United States

Site Status

Investigational Site Number 840862

Torrance, California, United States

Site Status

Investigational Site Number 840893

Vista, California, United States

Site Status

Investigational Site Number 840867

Boca Raton, Florida, United States

Site Status

Investigational Site Number 840884

Boynton Beach, Florida, United States

Site Status

Investigational Site Number 840836

Clearwater, Florida, United States

Site Status

Investigational Site Number 840866

Coral Gables, Florida, United States

Site Status

Investigational Site Number 840895

Fort Lauderdale, Florida, United States

Site Status

Investigational Site Number 840820

Hialeah, Florida, United States

Site Status

Investigational Site Number 840805

Miami, Florida, United States

Site Status

Investigational Site Number 840811

Oviedo, Florida, United States

Site Status

Investigational Site Number 840881

Port Orange, Florida, United States

Site Status

Investigational Site Number 840816

West Palm Beach, Florida, United States

Site Status

Investigational Site Number 840850

Columbus, Georgia, United States

Site Status

Investigational Site Number 840840

Eagle, Idaho, United States

Site Status

Investigational Site Number 840842

Chicago, Illinois, United States

Site Status

Investigational Site Number 840898

Evanston, Illinois, United States

Site Status

Investigational Site Number 840847

Morton, Illinois, United States

Site Status

Investigational Site Number 840896

Indianapolis, Indiana, United States

Site Status

Investigational Site Number 840894

Michigan City, Indiana, United States

Site Status

Investigational Site Number 840838

Mishawaka, Indiana, United States

Site Status

Investigational Site Number 840823

Paducah, Kentucky, United States

Site Status

Investigational Site Number 840858

Eunice, Louisiana, United States

Site Status

Investigational Site Number 840802

New Orleans, Louisiana, United States

Site Status

Investigational Site Number 840855

Salisbury, Massachusetts, United States

Site Status

Investigational Site Number 840890

Battle Creek, Michigan, United States

Site Status

Investigational Site Number 840832

Southfield, Michigan, United States

Site Status

Investigational Site Number 840839

Edina, Minnesota, United States

Site Status

Investigational Site Number 840888

Minneapolis, Minnesota, United States

Site Status

Investigational Site Number 840837

Port Gibson, Mississippi, United States

Site Status

Investigational Site Number 840814

Jefferson City, Missouri, United States

Site Status

Investigational Site Number 840833

Sparks, Nevada, United States

Site Status

Investigational Site Number 840817

Newington, New Hampshire, United States

Site Status

Investigational Site Number 840853

New Windsor, New York, United States

Site Status

Investigational Site Number 840822

Rochester, New York, United States

Site Status

Investigational Site Number 840824

Cary, North Carolina, United States

Site Status

Investigational Site Number 840880

Smithfield, North Carolina, United States

Site Status

Investigational Site Number 840502

Winston-Salem, North Carolina, United States

Site Status

Investigational Site Number 840852

Winston-Salem, North Carolina, United States

Site Status

Investigational Site Number 840846

Cincinnati, Ohio, United States

Site Status

Investigational Site Number 840899

Cincinnati, Ohio, United States

Site Status

Investigational Site Number 840831

Columbus, Ohio, United States

Site Status

Investigational Site Number 840860

Kettering, Ohio, United States

Site Status

Investigational Site Number 840809

Willoughby Hills, Ohio, United States

Site Status

Investigational Site Number 840818

Norman, Oklahoma, United States

Site Status

Investigational Site Number 840812

Eugene, Oregon, United States

Site Status

Investigational Site Number 840803

Downington, Pennsylvania, United States

Site Status

Investigational Site Number 840869

Philadelphia, Pennsylvania, United States

Site Status

Investigational Site Number 840825

Pittsburgh, Pennsylvania, United States

Site Status

Investigational Site Number 840872

Anderson, South Carolina, United States

Site Status

Investigational Site Number 840885

Charleston, South Carolina, United States

Site Status

Investigational Site Number 840813

Greer, South Carolina, United States

Site Status

Investigational Site Number 840827

Mt. Pleasant, South Carolina, United States

Site Status

Investigational Site Number 840868

Corpus Christi, Texas, United States

Site Status

Investigational Site Number 840877

Houston, Texas, United States

Site Status

Investigational Site Number 840841

Houston, Texas, United States

Site Status

Investigational Site Number 840830

San Antonio, Texas, United States

Site Status

Investigational Site Number 840854

San Antonio, Texas, United States

Site Status

Investigational Site Number 840883

San Antonio, Texas, United States

Site Status

Investigational Site Number 840889

Tomball, Texas, United States

Site Status

Investigational Site Number 840878

Bountiful, Utah, United States

Site Status

Investigational Site Number 840819

Orem, Utah, United States

Site Status

Investigational Site Number 840863

Salt Lake City, Utah, United States

Site Status

Investigational Site Number 840804

Manassas, Virginia, United States

Site Status

Investigational Site Number 840882

Norfolk, Virginia, United States

Site Status

Investigational Site Number 840810

Weber City, Virginia, United States

Site Status

Countries

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United States

References

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Colhoun HM, Robinson JG, Farnier M, Cariou B, Blom D, Kereiakes DJ, Lorenzato C, Pordy R, Chaudhari U. Efficacy and safety of alirocumab, a fully human PCSK9 monoclonal antibody, in high cardiovascular risk patients with poorly controlled hypercholesterolemia on maximally tolerated doses of statins: rationale and design of the ODYSSEY COMBO I and II trials. BMC Cardiovasc Disord. 2014 Sep 20;14:121. doi: 10.1186/1471-2261-14-121.

Reference Type BACKGROUND
PMID: 25240705 (View on PubMed)

Kereiakes DJ, Robinson JG, Cannon CP, Lorenzato C, Pordy R, Chaudhari U, Colhoun HM. Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab among high cardiovascular risk patients on maximally tolerated statin therapy: The ODYSSEY COMBO I study. Am Heart J. 2015 Jun;169(6):906-915.e13. doi: 10.1016/j.ahj.2015.03.004. Epub 2015 Mar 13.

Reference Type RESULT
PMID: 26027630 (View on PubMed)

Mahmood T, Minnier J, Ito MK, Li QH, Koren A, Kam IW, Fazio S, Shapiro MD. Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies. Eur J Prev Cardiol. 2021 Jul 23;28(8):816-822. doi: 10.1177/2047487320915803. Epub 2020 Apr 10.

Reference Type DERIVED
PMID: 34298554 (View on PubMed)

Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.

Reference Type DERIVED
PMID: 30183102 (View on PubMed)

Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. doi: 10.1161/CIRCULATIONAHA.116.024604. Epub 2016 Oct 24.

Reference Type DERIVED
PMID: 27777279 (View on PubMed)

Other Identifiers

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U1111-1121-4356

Identifier Type: OTHER

Identifier Source: secondary_id

EFC11568

Identifier Type: -

Identifier Source: org_study_id

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