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Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

NCT ID: NCT01623115

Last Updated: 2016-02-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

486 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-12-31

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 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

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Detailed Description

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The maximum study duration was planned to be 89 weeks per participant including participants who successfully completed the 78-week treatment period had the possibility to join an open-label extension study (LTS13463, NCT01954394) at the end of the treatment 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

Placebo for alirocumab every 2 weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks.

Group Type PLACEBO_COMPARATOR

Placebo (for alirocumab)

Intervention Type DRUG

Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using 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 75 mg/Up to 150 mg Q2W

Alirocumab 75 mg Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.

Group Type EXPERIMENTAL

Alirocumab

Intervention Type DRUG

Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using 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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Alirocumab

Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre filled pen).

Intervention Type DRUG

Placebo (for alirocumab)

Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using 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 Praluent

Eligibility Criteria

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Inclusion Criteria

* Participants with heterozygous familial hypercholesterolemia who were not adequately controlled with their lipid-modifying therapy

Exclusion Criteria

* Age \< 18 years or legal age of adulthood, whichever is greater
* LDL-C \< 70 mg/dL (1.81 mmol/L) and with cardiovascular disease
* LDL-C \< 100 mg/dL (2.59 mmol/L) and without cardiovascular disease
* Fasting serum triglycerides \> 400 mg/dL (4.52 mmol/L)
* Known history of homozygous familial hypercholesterolemia

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 840417

Bell Gardens, California, United States

Site Status

Investigational Site Number 840429

Long Beach, California, United States

Site Status

Investigational Site Number 840419

Los Angeles, California, United States

Site Status

Investigational Site Number 840421

Mission Viejo, California, United States

Site Status

Investigational Site Number 840412

Newport Beach, California, United States

Site Status

Investigational Site Number 840428

Newport Beach, California, United States

Site Status

Investigational Site Number 840461

Northridge, California, United States

Site Status

Investigational Site Number 840452

Washington D.C., District of Columbia, United States

Site Status

Investigational Site Number 840456

Miami, Florida, United States

Site Status

Investigational Site Number 840418

Ponte Vedra, Florida, United States

Site Status

Investigational Site Number 840455

Evanston, Illinois, United States

Site Status

Investigational Site Number 840415

Kansas City, Kansas, United States

Site Status

Investigational Site Number 840425

Auburn, Maine, United States

Site Status

Investigational Site Number 840411

Boston, Massachusetts, United States

Site Status

Investigational Site Number 840409

St Louis, Missouri, United States

Site Status

Investigational Site Number 840407

Morristown, New Jersey, United States

Site Status

Investigational Site Number 840408

New York, New York, United States

Site Status

Investigational Site Number 840401

Charlotte, North Carolina, United States

Site Status

Investigational Site Number 840410

Durham, North Carolina, United States

Site Status

Investigational Site Number 840430

Cincinnati, Ohio, United States

Site Status

Investigational Site Number 840424

Portland, Oregon, United States

Site Status

Investigational Site Number 840404

Philadelphia, Pennsylvania, United States

Site Status

Investigational Site Number 840426

Philadelphia, Pennsylvania, United States

Site Status

Investigational Site Number 840406

Nashville, Tennessee, United States

Site Status

Investigational Site Number 840460

Dallas, Texas, United States

Site Status

Investigational Site Number 840422

Bountiful, Utah, United States

Site Status

Investigational Site Number 040403

Graz, , Austria

Site Status

Investigational Site Number 040402

Vienna, , Austria

Site Status

Investigational Site Number 040405

Vienna, , Austria

Site Status

Investigational Site Number 124404

Chicoutimi, , Canada

Site Status

Investigational Site Number 124401

Montreal, , Canada

Site Status

Investigational Site Number 124403

Québec, , Canada

Site Status

Investigational Site Number 124406

Sherbrooke, , Canada

Site Status

Investigational Site Number 124407

Toronto, , Canada

Site Status

Investigational Site Number 203401

Prague, , Czechia

Site Status

Investigational Site Number 203403

Prague, , Czechia

Site Status

Investigational Site Number 203405

Uherské Hradiště, , Czechia

Site Status

Investigational Site Number 203402

Zlín, , Czechia

Site Status

Investigational Site Number 208401

Copenhagen, , Denmark

Site Status

Investigational Site Number 208403

Esbjerg, , Denmark

Site Status

Investigational Site Number 250403

Dijon, , France

Site Status

Investigational Site Number 250401

Paris, , France

Site Status

Investigational Site Number 250402

Saint-Herblain, , France

Site Status

Investigational Site Number 376402

Holon, , Israel

Site Status

Investigational Site Number 376405

Jerusalem, , Israel

Site Status

Investigational Site Number 376404

Safed, , Israel

Site Status

Investigational Site Number 376401

Tel Litwinsky, , Israel

Site Status

Investigational Site Number 528406

Amsterdam, , Netherlands

Site Status

Investigational Site Number 528410

Amsterdam, , Netherlands

Site Status

Investigational Site Number 528408

Den Helder, , Netherlands

Site Status

Investigational Site Number 528402

Groningen, , Netherlands

Site Status

Investigational Site Number 528411

Leiden, , Netherlands

Site Status

Investigational Site Number 528416

Maastricht, , Netherlands

Site Status

Investigational Site Number 528409

Nieuwegein, , Netherlands

Site Status

Investigational Site Number 528412

Sliedrecht, , Netherlands

Site Status

Investigational Site Number 578401

Bodø, , Norway

Site Status

Investigational Site Number 643402

Arkhangelsk, , Russia

Site Status

Investigational Site Number 643407

Kazan', , Russia

Site Status

Investigational Site Number 643409

Moscow, , Russia

Site Status

Investigational Site Number 643413

Moscow, , Russia

Site Status

Investigational Site Number 643401

Moscow, , Russia

Site Status

Investigational Site Number 643412

Novisibirsk, , Russia

Site Status

Investigational Site Number 643408

Saint Petersburg, , Russia

Site Status

Investigational Site Number 643406

Saint Petersburg, , Russia

Site Status

Investigational Site Number 643404

Saint Petersburg, , Russia

Site Status

Investigational Site Number 643410

Yaroslavl, , Russia

Site Status

Investigational Site Number 710401

Bloemfontein, , South Africa

Site Status

Investigational Site Number 710405

Bloemfontein, , South Africa

Site Status

Investigational Site Number 710406

Cap Town, , South Africa

Site Status

Investigational Site Number 710402

Cape Town, , South Africa

Site Status

Investigational Site Number 710407

Parktown, , South Africa

Site Status

Investigational Site Number 710403

Parow, , South Africa

Site Status

Investigational Site Number 710408

Pretoria, , South Africa

Site Status

Investigational Site Number 710404

Rondebosch, , South Africa

Site Status

Investigational Site Number 710409

Somerset West, , South Africa

Site Status

Investigational Site Number 724403

A Coruña, , Spain

Site Status

Investigational Site Number 724408

Barcelona, , Spain

Site Status

Investigational Site Number 724406

Córdoba, , Spain

Site Status

Investigational Site Number 724407

L'Hospitalet de Llobregat, , Spain

Site Status

Investigational Site Number 724409

Madrid, , Spain

Site Status

Investigational Site Number 724401

Madrid, , Spain

Site Status

Investigational Site Number 724405

Madrid, , Spain

Site Status

Investigational Site Number 724404

Reus, , Spain

Site Status

Investigational Site Number 724402

Zaragoza, , Spain

Site Status

Investigational Site Number 752404

Gothenburg, , Sweden

Site Status

Investigational Site Number 752401

Stockholm, , Sweden

Site Status

Investigational Site Number 826402

London, , United Kingdom

Site Status

Investigational Site Number 826403

London, , United Kingdom

Site Status

Investigational Site Number 826408

London, , United Kingdom

Site Status

Investigational Site Number 826409

London, , United Kingdom

Site Status

Investigational Site Number 826405

Manchester, , United Kingdom

Site Status

Countries

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United States Austria Canada Czechia Denmark France Israel Netherlands Norway Russia South Africa Spain Sweden United Kingdom

References

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Kastelein JJ, Robinson JG, Farnier M, Krempf M, Langslet G, Lorenzato C, Gipe DA, Baccara-Dinet MT. Efficacy and safety of alirocumab in patients with heterozygous familial hypercholesterolemia not adequately controlled with current lipid-lowering therapy: design and rationale of the ODYSSEY FH studies. Cardiovasc Drugs Ther. 2014 Jun;28(3):281-9. doi: 10.1007/s10557-014-6523-z.

Reference Type BACKGROUND
PMID: 24842558 (View on PubMed)

Kastelein JJ, Ginsberg HN, Langslet G, Hovingh GK, Ceska R, Dufour R, Blom D, Civeira F, Krempf M, Lorenzato C, Zhao J, Pordy R, Baccara-Dinet MT, Gipe DA, Geiger MJ, Farnier M. ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia. Eur Heart J. 2015 Nov 14;36(43):2996-3003. doi: 10.1093/eurheartj/ehv370. Epub 2015 Sep 1.

Reference Type RESULT
PMID: 26330422 (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)

Defesche JC, Stefanutti C, Langslet G, Hopkins PN, Seiz W, Baccara-Dinet MT, Hamon SC, Banerjee P, Kastelein JJP. Efficacy of alirocumab in 1191 patients with a wide spectrum of mutations in genes causative for familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1338-1346.e7. doi: 10.1016/j.jacl.2017.08.016. Epub 2017 Sep 4.

Reference Type DERIVED
PMID: 28964736 (View on PubMed)

Kastelein JJ, Hovingh GK, Langslet G, Baccara-Dinet MT, Gipe DA, Chaudhari U, Zhao J, Minini P, Farnier M. Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 monoclonal antibody alirocumab vs placebo in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Jan-Feb;11(1):195-203.e4. doi: 10.1016/j.jacl.2016.12.004. Epub 2016 Dec 28.

Reference Type DERIVED
PMID: 28391886 (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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U1111-1121-4275

Identifier Type: OTHER

Identifier Source: secondary_id

2011-005109-56

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EFC12492

Identifier Type: -

Identifier Source: org_study_id

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