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Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)

NCT ID: NCT01644188

Last Updated: 2016-08-04

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-07-31

Brief Summary

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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 in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high cardiovascular (CV) risk.

Secondary Objectives:

* To evaluate the effect of alirocumab in comparison with ezetimibe 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 115 weeks per participant, including a 3-week screening period, 104-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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Alirocumab 75 /up to 150 mg Q2W

Alirocumab 75 mg every 2 weeks (Q2W) and oral placebo capsule for ezetimibe daily added to stable Lipid Modifying Therapy (LMT) for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.

Group Type EXPERIMENTAL

Alirocumab

Intervention Type DRUG

1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.

Placebo (for ezetimibe)

Intervention Type DRUG

One capsule once daily orally at approximately the same time of the day with or without food.

Lipid Modifying Therapy (LMT)

Intervention Type DRUG

Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.

Ezetimibe 10 mg

Ezetimibe 10 mg capsule daily and subcutaneous placebo for alirocumab Q2W added to stable LMT for 104 weeks.

Group Type ACTIVE_COMPARATOR

Placebo (for alirocumab)

Intervention Type DRUG

1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.

Ezetimibe

Intervention Type DRUG

One over-encapsulated tablet orally once daily at approximately the same time of the day with or without food.

Lipid Modifying Therapy (LMT)

Intervention Type DRUG

Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.

Interventions

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Alirocumab

1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.

Intervention Type DRUG

Placebo (for alirocumab)

1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.

Intervention Type DRUG

Ezetimibe

One over-encapsulated tablet orally once daily at approximately the same time of the day with or without food.

Intervention Type DRUG

Placebo (for ezetimibe)

One capsule once daily orally at approximately the same time of the day with or without food.

Intervention Type DRUG

Lipid Modifying Therapy (LMT)

Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.

Intervention Type DRUG

Other Intervention Names

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REGN727/SAR236553 Praluent

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 at stable dose for at least 4 weeks prior to the screening visit (Week -2).

Exclusion Criteria

* Age \< 18 or legal age of adulthood, whichever was greater
* Participants without established CHD or CHD risk equivalents
* 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 CV disease
* Fasting serum triglycerides \>400 mg/dL (\>4.52 mmol/L)

The above information was 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 840980

Birmingham, Alabama, United States

Site Status

Investigational Site Number 840918

Phoenix, Arizona, United States

Site Status

Investigational Site Number 840925

Tucson, Arizona, United States

Site Status

Investigational Site Number 840959

Anaheim, California, United States

Site Status

Investigational Site Number 840301

Beverly Hills, California, United States

Site Status

Investigational Site Number 840933

Chino, California, United States

Site Status

Investigational Site Number 840991

Lincoln, California, United States

Site Status

Investigational Site Number 840979

Los Angeles, California, United States

Site Status

Investigational Site Number 840952

Palm Springs, California, United States

Site Status

Investigational Site Number 840930

Thousand Oaks, California, United States

Site Status

Investigational Site Number 840921

Vista, California, United States

Site Status

Investigational Site Number 840962

Boynton Beach, Florida, United States

Site Status

Investigational Site Number 840987

Bradenton, Florida, United States

Site Status

Investigational Site Number 840302

Clearwater, Florida, United States

Site Status

Investigational Site Number 840935

Jacksonville, Florida, United States

Site Status

Investigational Site Number 840903

Miami, Florida, United States

Site Status

Investigational Site Number 840920

Miami, Florida, United States

Site Status

Investigational Site Number 840943

Ocala, Florida, United States

Site Status

Investigational Site Number 840981

Oveido, Florida, United States

Site Status

Investigational Site Number 840961

Port Orange, Florida, United States

Site Status

Investigational Site Number 840303

Sarasota, Florida, United States

Site Status

Investigational Site Number 840986

St. Petersburg, Florida, United States

Site Status

Investigational Site Number 840988

St. Petersburg, Florida, United States

Site Status

Investigational Site Number 840995

Meridian, Idaho, United States

Site Status

Investigational Site Number 840902

Evansville, Indiana, United States

Site Status

Investigational Site Number 840960

Topeka, Kansas, United States

Site Status

Investigational Site Number 840940

Oxon Hill, Maryland, United States

Site Status

Investigational Site Number 840966

Fall River, Massachusetts, United States

Site Status

Investigational Site Number 840917

Kansas City, Missouri, United States

Site Status

Investigational Site Number 840998

St Louis, Missouri, United States

Site Status

Investigational Site Number 840946

Butte, Montana, United States

Site Status

Investigational Site Number 840914

Lincoln, Nebraska, United States

Site Status

Investigational Site Number 840949

Albuquerque, New Mexico, United States

Site Status

Investigational Site Number 840974

New Windsor, New York, United States

Site Status

Investigational Site Number 840955

Greenville, North Carolina, United States

Site Status

Investigational Site Number 840938

Lexington, North Carolina, United States

Site Status

Investigational Site Number 840976

Smithfield, North Carolina, United States

Site Status

Investigational Site Number 840985

Winston-Salem, North Carolina, United States

Site Status

Investigational Site Number 840963

Cincinnati, Ohio, United States

Site Status

Investigational Site Number 840970

Lyndhust, Ohio, United States

Site Status

Investigational Site Number 840906

Marion, Ohio, United States

Site Status

Investigational Site Number 840997

Marion, Ohio, United States

Site Status

Investigational Site Number 840964

Perrysburg, Ohio, United States

Site Status

Investigational Site Number 840913

Charleston, South Carolina, United States

Site Status

Investigational Site Number 840912

Greer, South Carolina, United States

Site Status

Investigational Site Number 840992

Summerville, South Carolina, United States

Site Status

Investigational Site Number 840932

Bristol, Tennessee, United States

Site Status

Investigational Site Number 840944

Nashville, Tennessee, United States

Site Status

Investigational Site Number 840994

Fort Worth, Texas, United States

Site Status

Investigational Site Number 840973

Houston, Texas, United States

Site Status

Investigational Site Number 840939

Houston, Texas, United States

Site Status

Investigational Site Number 840945

Sugar Land, Texas, United States

Site Status

Investigational Site Number 840971

Tomball, Texas, United States

Site Status

Investigational Site Number 840982

Orem, Utah, United States

Site Status

Investigational Site Number 840931

Norfolk, Virginia, United States

Site Status

Investigational Site Number 840984

Richmond, Virginia, United States

Site Status

Investigational Site Number 840928

Renton, Washington, United States

Site Status

Investigational Site Number 840990

Spokane, Washington, United States

Site Status

Investigational Site Number 124902

Brampton, , Canada

Site Status

Investigational Site Number 124914

Mirabel, , Canada

Site Status

Investigational Site Number 124903

Montreal, , Canada

Site Status

Investigational Site Number 124918

Toronto, , Canada

Site Status

Investigational Site Number 208913

Esbjerg, , Denmark

Site Status

Investigational Site Number 208914

Glostrup Municipality, , Denmark

Site Status

Investigational Site Number 208905

Hellerup, , Denmark

Site Status

Investigational Site Number 208911

Herlev, , Denmark

Site Status

Investigational Site Number 208907

Hvidovre, , Denmark

Site Status

Investigational Site Number 208901

København S, , Denmark

Site Status

Investigational Site Number 208906

Køge, , Denmark

Site Status

Investigational Site Number 208908

Roskilde, , Denmark

Site Status

Investigational Site Number 208903

Silkeborg, , Denmark

Site Status

Investigational Site Number 250906

Dijon, , France

Site Status

Investigational Site Number 250907

Montpellier, , France

Site Status

Investigational Site Number 250903

Nantes, , France

Site Status

Investigational Site Number 250905

Nîmes, , France

Site Status

Investigational Site Number 348908

Budapest, , Hungary

Site Status

Investigational Site Number 348901

Budapest, , Hungary

Site Status

Investigational Site Number 348903

Budapest, , Hungary

Site Status

Investigational Site Number 348905

Debrecen, , Hungary

Site Status

Investigational Site Number 348906

Székesfehérvár, , Hungary

Site Status

Investigational Site Number 376908

Holon, , Israel

Site Status

Investigational Site Number 376903

Kfar Saba, , Israel

Site Status

Investigational Site Number 376906

Ofakim, , Israel

Site Status

Investigational Site Number 376902

Petah Tikva, , Israel

Site Status

Investigational Site Number 376904

Rehovot, , Israel

Site Status

Investigational Site Number 376907

Safed, , Israel

Site Status

Investigational Site Number 376901

Tel Aviv, , Israel

Site Status

Investigational Site Number 643906

Barnaul, , Russia

Site Status

Investigational Site Number 643903

Kemerovo, , Russia

Site Status

Investigational Site Number 643927

Moscow, , Russia

Site Status

Investigational Site Number 643928

Moscow, , Russia

Site Status

Investigational Site Number 643931

Moscow, , Russia

Site Status

Investigational Site Number 643924

Moscow, , Russia

Site Status

Investigational Site Number 643932

Moscow, , Russia

Site Status

Investigational Site Number 643908

Moscow, , Russia

Site Status

Investigational Site Number 643904

Moscow, , Russia

Site Status

Investigational Site Number 643911

Orenburg, , Russia

Site Status

Investigational Site Number 643921

Ryazan, , Russia

Site Status

Investigational Site Number 643925

Saint Petersburg, , Russia

Site Status

Investigational Site Number 643922

Saint Petersburg, , Russia

Site Status

Investigational Site Number 643914

Saint Petersburg, , Russia

Site Status

Investigational Site Number 643929

Saratov, , Russia

Site Status

Investigational Site Number 710917

Alberton, , South Africa

Site Status

Investigational Site Number 710909

Bloemfontein, , South Africa

Site Status

Investigational Site Number 710914

Bloemfontein, , South Africa

Site Status

Investigational Site Number 710905

Cape Town, , South Africa

Site Status

Investigational Site Number 710904

Cape Town, , South Africa

Site Status

Investigational Site Number 710918

Middelburg, , South Africa

Site Status

Investigational Site Number 710913

Pretoria, , South Africa

Site Status

Investigational Site Number 710915

Somerset West, , South Africa

Site Status

Investigational Site Number 410908

Anyang-si, , South Korea

Site Status

Investigational Site Number 410920

Busan, , South Korea

Site Status

Investigational Site Number 410926

Daegu, , South Korea

Site Status

Investigational Site Number 410923

Gwangju, , South Korea

Site Status

Investigational Site Number 410909

Seoul, , South Korea

Site Status

Investigational Site Number 410922

Seoul, , South Korea

Site Status

Investigational Site Number 410921

Seoul, , South Korea

Site Status

Investigational Site Number 410905

Seoul, , South Korea

Site Status

Investigational Site Number 410901

Seoul, , South Korea

Site Status

Investigational Site Number 410914

Seoul, , South Korea

Site Status

Investigational Site Number 410924

Seoul, , South Korea

Site Status

Investigational Site Number 410915

Suwon, , South Korea

Site Status

Investigational Site Number 410913

Uijeongbu-si, , South Korea

Site Status

Investigational Site Number 410927

Wŏnju, , South Korea

Site Status

Investigational Site Number 804905

Kiev, , Ukraine

Site Status

Investigational Site Number 804902

Uzhhorod, , Ukraine

Site Status

Countries

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United States Canada Denmark France Hungary Israel Russia South Africa South Korea Ukraine

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)

Cannon CP, Cariou B, Blom D, McKenney JM, Lorenzato C, Pordy R, Chaudhari U, Colhoun HM; ODYSSEY COMBO II Investigators. Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated doses of statins: the ODYSSEY COMBO II randomized controlled trial. Eur Heart J. 2015 May 14;36(19):1186-94. doi: 10.1093/eurheartj/ehv028. Epub 2015 Feb 16.

Reference Type RESULT
PMID: 25687353 (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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U1111-1121-4315

Identifier Type: OTHER

Identifier Source: secondary_id

2011-004130-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EFC11569

Identifier Type: -

Identifier Source: org_study_id

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