AzTrials
AzTrials

HypercholesterolemiaPhase 3NCT01507831

Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

A Phase 3 study testing Alirocumab and Lipid-Modifying Therapy (LMT) in people with Hypercholesterolemia, run by Sanofi at 320 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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 long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypercholesterolemia
What is being tested?
Alirocumab and Lipid-Modifying Therapy (LMT)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,341 participants
Where
320 sitesin 27 countries
Study dates
Jan 2012to Nov 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Either A or B below and who were not adequately controlled with their lipid-modifying therapy:
  • Participants with heterozygous familial hypercholesterolemia (heFH) with or without established coronary heart disease (CHD) or CHD risk equivalents
  • OR
  • Participants with hypercholesterolemia together with established CHD or CHD risk equivalents.

Who cannot join

  • Age < 18 years
  • LDL-C <70 mg/dL (< 1.81 mmol/L)
  • 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.

Trial locations and contacts

320 sites in 27 countries.

320 sites in 27 countries

United States115 sites

  • Investigational Site Number 840217

    Asheville, North Carolina, 28803

  • Investigational Site Number 840150

    Atlantis, Florida, 33462

  • Investigational Site Number 840170

    Beaver, Pennsylvania, 15009

  • Investigational Site Number 840209

    Beverly Hills, California, 90210

  • Investigational Site Number 840194

    Beverly Hills, California, 90211

  • Investigational Site Number 840244

    Biddeford, Maine, 04005

  • Investigational Site Number 840020

    Bradenton, Florida, 34208

  • Investigational Site Number 840041

    Brandon, Florida, 33511

  • Investigational Site Number 840224

    Bridgeport, Connecticut, 06610

  • Investigational Site Number 840097

    Bronxville, New York, 10708

  • Investigational Site Number 840129

    Brooklyn, New York, 11215

  • Investigational Site Number 840180

    Camp Hill, Pennsylvania, 17011

  • Investigational Site Number 840073

    Charleston, South Carolina, 29485

  • Investigational Site Number 840023

    Charlotte, North Carolina, 28211

  • Investigational Site Number 840204

    Chesapeake, Virginia, 23320

  • Investigational Site Number 840068

    Cincinnati, Ohio, 45236

  • Investigational Site Number 840184

    Clearwater, Florida, 33756

  • Investigational Site Number 840242

    Clearwater, Florida, 33756

  • Investigational Site Number 840039

    Clearwater, Florida, 33765

  • Investigational Site Number 840086

    Colorado Springs, Colorado, 80906

  • Investigational Site Number 840182

    Crystal River, Florida, 34429

  • Investigational Site Number 840117

    Cumming, Georgia, 30041

  • Investigational Site Number 840092

    Dallas, Texas, 75216

  • Investigational Site Number 840212

    Dallas, Texas, 75226

  • Investigational Site Number 840007

    Dayton, Ohio, 45406

  • Investigational Site Number 840002

    Daytona Beach, Florida, 32117

  • Investigational Site Number 840166

    Daytona Beach, Florida, 32117

  • Investigational Site Number 840004

    Duncansville, Pennsylvania, 16635

  • Investigational Site Number 840022

    Edison, New Jersey, 08817

  • Investigational Site Number 840027

    Evansville, Indiana, 47714

  • Investigational Site Number 840167

    Fleming Island, Florida, 32003

  • Investigational Site Number 840090

    Fort Lauderdale, Florida, 33308

  • Investigational Site Number 840018

    Fort Lauderdale, Florida, 33309

  • Investigational Site Number 840058

    Fort Worth, Texas, 76104

  • Investigational Site Number 840149

    Fort Worth, Texas, 76104

  • Investigational Site Number 840070

    Fort Worth, Texas, 76117

  • Investigational Site Number 840158

    Framingham, Maine, 01702

  • Investigational Site Number 840207

    Fresno, California, 93720

  • Investigational Site Number 840028

    Gilbert, Arizona, 85295

  • Investigational Site Number 840077

    Golden, Colorado, 80401

  • Investigational Site Number 840083

    Greensboro, North Carolina, 27408

  • Investigational Site Number 840087

    Greenville, South Carolina, 29615

  • Investigational Site Number 840134

    Guilford, Connecticut, 06437

  • Investigational Site Number 840246

    Hartford, Connecticut, 06102

  • Investigational Site Number 840095

    Henderson, Nevada, 89052

  • Investigational Site Number 840096

    Henderson, Nevada, 89052

  • Investigational Site Number 840011

    Hillsborough, New Jersey, 08844

  • Investigational Site Number 840038

    Houston, Texas, 77024

  • Investigational Site Number 840047

    Houston, Texas, 77074

  • Investigational Site Number 840159

    Huntsville, Alabama, 35801

  • Investigational Site Number 840093

    Indianapolis, Indiana, 46260

  • Investigational Site Number 840222

    Iowa City, Iowa, 52242

  • Investigational Site Number 840153

    Jacksonville, Florida, 32204

  • Investigational Site Number 840181

    Jacksonville, Florida, 32205

  • Investigational Site Number 840152

    Jacksonville, Florida, 32216

  • Investigational Site Number 840046

    Jersey Shore, Pennsylvania, 17740

  • Investigational Site Number 840200

    Kansas City, Kansas, 66160-7321

  • Investigational Site Number 840190

    Knoxville, Tennessee, 37917

  • Investigational Site Number 840154

    Lake Mary, Florida, 32746

  • Investigational Site Number 840059

    Largo, Florida, 33773

  • Investigational Site Number 840101

    Lincoln, California, 95648

  • Investigational Site Number 840076

    Long Beach, California, 90807

  • Investigational Site Number 840013

    Marion, Ohio, 43302

  • Investigational Site Number 840161

    Mentor, Ohio, 44060

  • Investigational Site Number 840075

    Meridian, Idaho, 83646

  • Investigational Site Number 840221

    Miami, Florida, 33176

  • Investigational Site Number 840111

    Milwaukee, Wisconsin, 53209-0996

  • Investigational Site Number 840021

    New Port Richey, Florida, 34652

  • Investigational Site Number 840122

    New Smyrna Beach, Florida, 32169

  • Investigational Site Number 840193

    Novi, Michigan, 48374

  • Investigational Site Number 840151

    Ocala, Florida, 34471

  • Investigational Site Number 840108

    Ormond Beach, Florida, 32174

  • Investigational Site Number 840067

    Palm Harbor, Florida, 34684

  • Investigational Site Number 840214

    Pasadena, California, 91105

  • Investigational Site Number 840006

    Pembroke Pines, Florida, 33026

  • Investigational Site Number 840155

    Phoenixville, Pennsylvania, 19460

  • Investigational Site Number 840053

    Plano, Texas, 75023

  • Investigational Site Number 840168

    Ponte Vedra, Florida, 32081

  • Investigational Site Number 840160

    Poughkeepsie, New York, 12601

  • Investigational Site Number 840104

    Raleigh, North Carolina, 27609

  • Investigational Site Number 840110

    Roswell, Georgia, 30076

  • Investigational Site Number 840045

    Sacramento, California, 95842

  • Investigational Site Number 840162

    Saginaw, Michigan, 48604

  • Investigational Site Number 840031

    Salt Lake City, Utah, 84107

  • Investigational Site Number 840163

    Santa Rosa, California, 95405

  • Investigational Site Number 840164

    Sarasota, Florida, 34239

  • Investigational Site Number 840175

    Sarasota, Florida, 34239

  • Investigational Site Number 840026

    Savannah, Georgia, 31405

  • Investigational Site Number 840177

    Scranton, Pennsylvania, 18508

  • Investigational Site Number 840035

    Sierra Vista, Arizona, 85635

  • Investigational Site Number 840074

    Simpsonville, South Carolina, 29681

  • Investigational Site Number 840120

    Spokane, Washington, 99204

  • Investigational Site Number 840033

    St Louis, Missouri, 63117

  • Investigational Site Number 840113

    St Louis, Missouri, 63131

  • Investigational Site Number 840001

    St. Petersburg, Florida

  • Investigational Site Number 840003

    St. Petersburg, Florida

  • Investigational Site Number 840055

    Stamford, Connecticut, 06905

  • Investigational Site Number 840091

    Stamford, Connecticut, 06905

  • Investigational Site Number 840072

    Sugar Land, Texas, 77479

  • Investigational Site Number 840052

    Tempe, Arizona, 85282

  • Investigational Site Number 840065

    Tempe, Arizona, 85282

  • Investigational Site Number 840079

    Tempe, Arizona, 85282

  • Investigational Site Number 840094

    Tempe, Arizona, 85282

  • Investigational Site Number 840049

    Trenton, New Jersey, 08611

  • Investigational Site Number 840103

    Tucson, Arizona, 85741-3565

  • Investigational Site Number 840005

    Tulsa, Oklahoma, 74136

  • Investigational Site Number 840241

    Tyler, Texas, 75701

  • Investigational Site Number 840105

    Varnville, South Carolina, 29944

  • Investigational Site Number 840165

    West Des Moines, Iowa, 50266

  • Investigational Site Number 840036

    West Palm Beach, Florida, 33401

  • Investigational Site Number 840040

    Wichita, Kansas, 67203

  • Investigational Site Number 840061

    Wichita, Kansas, 67205

  • Investigational Site Number 840032

    Wichita, Kansas, 67207

  • Investigational Site Number 840084

    Wichita, Kansas, 67207

  • Investigational Site Number 840202

    Wyomissing, Pennsylvania, 19610

Other trials in United States

United Kingdom19 sites

  • Investigational Site Number 826004

    Addlestone, KT15 2BH

  • Investigational Site Number 826009

    Birmingham, B15 2SQ

  • Investigational Site Number 826016

    Birmingham, B18 7QH

  • Investigational Site Number 826021

    Blackpool, FY3 7EN

  • Investigational Site Number 826023

    Cambridge, CB2 OQQ

  • Investigational Site Number 826012

    Cardiff, CF14 5GJ

  • Investigational Site Number 826024

    Chichester, PO19 4SE

  • Investigational Site Number 826006

    Chorley, PR7 7NA

  • Investigational Site Number 826010

    Glasgow, G20 0SP

  • Investigational Site Number 826003

    Irvine, KA12 0AY

  • Investigational Site Number 826008

    Liverpool, L22 0LG

  • Investigational Site Number 826005

    Liverpool, L7 8XP

  • Investigational Site Number 826025

    Manchester, M13 9WL

  • Investigational Site Number 826007

    Manchester, M15 6SX

  • Investigational Site Number 826001

    Middlesex, HA6 2RN

  • Investigational Site Number 826019

    Penzance, TR19 7HH

  • Investigational Site Number 826011

    Reading, RG2 7AG

  • Investigational Site Number 826013

    Romford, RM7 0AG

  • Investigational Site Number 826014

    Soham, CB7 5JD

Other trials in United Kingdom

Germany15 sites

  • Investigational Site Number 276001

    Bad Wörishofen, 86825

  • Investigational Site Number 276007

    Berlin, 12627

  • Investigational Site Number 276005

    Berlin, 13125

  • Investigational Site Number 276014

    Berlin, 13158

  • Investigational Site Number 276008

    Bochum, 44787

  • Investigational Site Number 276009

    Dresden, 01067

  • Investigational Site Number 276004

    Essen, 45355

  • Investigational Site Number 276010

    Frankfurt A.M., 60596

  • Investigational Site Number 276011

    Görlitz, 02826

  • Investigational Site Number 276019

    Hanover, 30159

  • Investigational Site Number 276013

    Leipzig, 04103

  • Investigational Site Number 276012

    Magdeburg, 39104

  • Investigational Site Number 276003

    Magdeburg, 39120

  • Investigational Site Number 276006

    Schwerin, 19055

  • Investigational Site Number 276015

    Witten, 58455

Other trials in Germany

Canada14 sites

  • Investigational Site Number 124013

    Cambridge, N1R 6V6

  • Investigational Site Number 124027

    Coquitlam, V3K 3P4

  • Investigational Site Number 124001

    Hawkesbury, K6A 1A1

  • Investigational Site Number 124002

    London, N5W 6A2

  • Investigational Site Number 124009

    Mirabel, J7J 2K8

  • Investigational Site Number 124018

    Montreal, H1T 3Y7

  • Investigational Site Number 124007

    Ottawa, K1K 4L2

  • Investigational Site Number 124011

    Québec, G1V 4M6

  • Investigational Site Number 124008

    Sarnia, N7T 4X3

  • Investigational Site Number 124005

    St. John's, A1A 3R5

  • Investigational Site Number 124022

    Terrebonne, J6V 1S8

  • Investigational Site Number 124003

    Vancouver, V5Z 1M9

  • Investigational Site Number 124006

    Victoria, V8T 5G4

  • Investigational Site Number 124015

    Woodstock, N4S 5P5

Other trials in Canada

France12 sites

  • Investigational Site Number 250007

    Bandol, 83150

  • Investigational Site Number 250003

    Broglie, 27270

  • Investigational Site Number 250014

    Bron, 69677

  • Investigational Site Number 250004

    Dijon, 21000

  • Investigational Site Number 250006

    Lille, 59037

  • Investigational Site Number 250009

    Nantes, 44093

  • Investigational Site Number 250001

    Nantes, 44300

  • Investigational Site Number 250002

    Paris, 75651

  • Investigational Site Number 250010

    Pessac, 33604

  • Investigational Site Number 250012

    Rennes, 35033

  • Investigational Site Number 250005

    Vieux-Condé, 59690

  • Investigational Site Number 250008

    Vihiers, 49310

Other trials in France

Netherlands12 sites

  • Investigational Site Number 528013

    Amsterdam, 1091 AC

  • Investigational Site Number 528001

    Amsterdam, 1105 AZ

  • Investigational Site Number 528004

    Breda, 4811 SW

  • Investigational Site Number 528005

    Eindhoven, 5616GB

  • Investigational Site Number 528007

    Groningen, 9711 SG

  • Investigational Site Number 528011

    Hoogeveen, 7909 AA

  • Investigational Site Number 528002

    Hoorn, 1625 HV

  • Investigational Site Number 528008

    Leiderdorp, 2352 RA

  • Investigational Site Number 528009

    Rotterdam, 3021 HC

  • Investigational Site Number 528006

    Velp, 6883 ES

  • Investigational Site Number 528012

    Venlo, 5912 BL

  • Investigational Site Number 528010

    Zoetermeer, 2724 EK

Other trials in Netherlands

South Africa11 sites

  • Investigational Site Number 710010

    Centurion, 0158

  • Investigational Site Number 710008

    Meyerspark, 0184

  • Investigational Site Number 710011

    Middelburg, 1055

  • Investigational Site Number 710006

    Parktown, 2193

  • Investigational Site Number 710004

    Pretoria, 0002

  • Investigational Site Number 710001

    Pretoria, 0084

  • Investigational Site Number 710002

    Pretoria, 181

  • Investigational Site Number 710009

    Roodepoort, 1724

  • Investigational Site Number 710003

    Somerset West, 7130

  • Investigational Site Number 710005

    Witbank

  • Investigational Site Number 710007

    Worcester, 6850

Other trials in South Africa

Ukraine11 sites

  • Investigational Site Number 804012

    Chernivtsi, 58013

  • Investigational Site Number 804003

    Dnipropetrovsk, 49006

  • Investigational Site Number 804002

    Donetsk, 83114

  • Investigational Site Number 804014

    Kharkiv, 61002

  • Investigational Site Number 804016

    Kiev, 02091

  • Investigational Site Number 804011

    Kyiv, 01103

  • Investigational Site Number 804010

    Kyiv, 03115

  • Investigational Site Number 804001

    Kyiv, 03680

  • Investigational Site Number 804008

    Kyiv, 04053

  • Investigational Site Number 804013

    Kyiv

  • Investigational Site Number 804005

    Zhytomyr, 10002

Other trials in Ukraine

Hungary10 sites

  • Investigational Site Number 348003

    Baja, 6500

  • Investigational Site Number 348007

    Budapest, 1036

  • Investigational Site Number 348009

    Budapest, 1036

  • Investigational Site Number 348008

    Budapest, 1135

  • Investigational Site Number 348013

    Budapest, 1136

  • Investigational Site Number 348004

    Debrecen, 4032

  • Investigational Site Number 348002

    Nagykanizsa, 8800

  • Investigational Site Number 348006

    Nyíregyháza, 4400

  • Investigational Site Number 348001

    Sopron, 9400

  • Investigational Site Number 348011

    Úrhida, 8142

Other trials in Hungary

Bulgaria9 sites

  • Investigational Site Number 100008

    Pleven, 5800

  • Investigational Site Number 100014

    Plovdiv, 4000

  • Investigational Site Number 100005

    Sofia, 1203

  • Investigational Site Number 100012

    Sofia, 1233

  • Investigational Site Number 100015

    Sofia, 1233

  • Investigational Site Number 100009

    Sofia, 1527

  • Investigational Site Number 100001

    Sofia, 1606

  • Investigational Site Number 100013

    Stara Zagora, 6000

  • Investigational Site Number 100007

    Varna, 9010

Other trials in Bulgaria

Poland9 sites

  • Investigational Site Number 616008

    Gdynia, 81-384

  • Investigational Site Number 616003

    Gdynia, 81423

  • Investigational Site Number 616001

    Gniewkowo, 88-140

  • Investigational Site Number 616010

    Katowice, 40-748

  • Investigational Site Number 616018

    Krakow, 31-315

  • Investigational Site Number 616004

    Piotrkow Trybunalski, 97-300

  • Investigational Site Number 616013

    Puławy, 24-100

  • Investigational Site Number 616009

    Warsaw, 02-777

  • Investigational Site Number 616007

    Wroclaw, 50-088

Other trials in Poland

Italy8 sites

  • Investigational Site Number 380006

    Chieti, 66013

  • Investigational Site Number 380002

    Cinisello Balsamo, 20092

  • Investigational Site Number 380009

    Milan, 20138

  • Investigational Site Number 380007

    Naples, 80131

  • Investigational Site Number 380001

    Palermo, 90127

  • Investigational Site Number 380005

    Pozzilli, 86077

  • Investigational Site Number 380008

    Vittorio Veneto, 31029

  • Investigational Site Number 380010

    Zingonia-Osio Sotto

Other trials in Italy

Spain8 sites

  • Investigational Site Number 724006

    Córdoba, 14004

  • Investigational Site Number 724003

    Granada, 18012

  • Investigational Site Number 724002

    Madrid, 28040

  • Investigational Site Number 724007

    Málaga, 29010

  • Investigational Site Number 724008

    Quart de Poblet, 46930

  • Investigational Site Number 724005

    Reus, 43201

  • Investigational Site Number 724001

    Sabadell, 08208

  • Investigational Site Number 724004

    Seville, 41013

Other trials in Spain

Mexico7 sites

  • Investigational Site Number 484010

    Df, 03300

  • Investigational Site Number 484004

    México, 06090

  • Investigational Site Number 484008

    Not Provided

  • Investigational Site Number 484001

    San Luis Potosí City, 78200

  • Investigational Site Number 484002

    Tijuana, 22500

  • Investigational Site Number 484009

    Torreón, 27000

  • Investigational Site Number 484003

    Xalapa, 91020

Other trials in Mexico

Russia7 sites

  • Investigational Site Number 643005

    Barnaul

  • Investigational Site Number 643012

    Moscow, 119415

  • Investigational Site Number 643008

    Moscow, 125284

  • Investigational Site Number 643014

    Perm, 614097

  • Investigational Site Number 643006

    Saint Petersburg, 196084

  • Investigational Site Number 643009

    Saint Petersburg, 196084

  • Investigational Site Number 643004

    Yaroslavl, 150002

Other trials in Russia

Argentina6 sites

  • Investigational Site Number 032006

    Buenos Aires, C1425DES

  • Investigational Site Number 032010

    Caba, C1440AAD

  • Investigational Site Number 032008

    Capital Federal, 1119

  • Investigational Site Number 032001

    Coronel Suárez, B7540GHD

  • Investigational Site Number 032004

    Resistencia, H3500CDM

  • Investigational Site Number 032007

    Zárate, B2800DGH

Other trials in Argentina

Colombia5 sites

  • Investigational Site Number 170004

    Barranquilla

  • Investigational Site Number 170005

    Barranquilla

  • Investigational Site Number 170008

    Barranquilla

  • Investigational Site Number 170001

    Manizales

  • Investigational Site Number 170003

    Medellín

Other trials in Colombia

Denmark5 sites

  • Investigational Site Number 208005

    Aarhus, 8200

  • Investigational Site Number 208004

    Hellerup, 2900

  • Investigational Site Number 208003

    Slagelse, 4200

  • Investigational Site Number 208001

    Svendborg, 5700

  • Investigational Site Number 208002

    Viborg, 8800

Other trials in Denmark

Norway5 sites

  • Investigational Site Number 578005

    Elverum, 2402

  • Investigational Site Number 578001

    Hamar, 2317

  • Investigational Site Number 578002

    Oslo

  • Investigational Site Number 578004

    Skedsmokorset, 2020

  • Investigational Site Number 578003

    Stavanger, 4005

Other trials in Norway

Sweden5 sites

  • Investigational Site Number 752001

    Örebro, 70146

  • Investigational Site Number 752002

    Rättvik, 79530

  • Investigational Site Number 752006

    Stockholm, 111 35

  • Investigational Site Number 752003

    Stockholm, 111 57

  • Investigational Site Number 752004

    Stockholm, 14186

Other trials in Sweden

Belgium4 sites

  • Investigational Site Number 056005

    Antwerp, 2020

  • Investigational Site Number 056004

    Genk, 3600

  • Investigational Site Number 056001

    Natoye, 5360

  • Investigational Site Number 056002

    Wetteren, 9230

Other trials in Belgium

Chile4 sites

  • Investigational Site Number 152007

    Osorno, 5311092

  • Investigational Site Number 152008

    Santiago, 7980378

  • Investigational Site Number 152006

    Santiago, 8053095

  • Investigational Site Number 152004

    Temuco, 4790869

Other trials in Chile

Finland4 sites

  • Investigational Site Number 246002

    Joensuu, 80100

  • Investigational Site Number 246001

    Kokkola, 67100

  • Investigational Site Number 246003

    Kuopio, 70210

  • Investigational Site Number 246004

    Vantaa, 01600

Other trials in Finland

Israel4 sites

  • Investigational Site Number 376002

    Afula, 18101

  • Investigational Site Number 376003

    Holon, 58100

  • Investigational Site Number 376005

    Holon, 58100

  • Investigational Site Number 376004

    Nazareth, 16100

Other trials in Israel

Portugal4 sites

  • Investigational Site Number 620006

    Funchal / Madeira, 9050

  • Investigational Site Number 620002

    Lisbon, 1169-024

  • Investigational Site Number 620001

    Lisbon, 1549-008

  • Investigational Site Number 620005

    Porto, 4200-319

Other trials in Portugal

Romania4 sites

  • Investigational Site Number 642005

    Baia Mare, 430031

  • Investigational Site Number 642002

    Brasov, 500283

  • Investigational Site Number 642004

    Târgu Mureş, 540099

  • Investigational Site Number 642001

    Timișoara, 300358

Other trials in Romania

Czechia3 sites

  • Investigational Site Number 203004

    Prague, 128 08

  • Investigational Site Number 203007

    Prague, 15006

  • Investigational Site Number 203006

    Prague, 15800

Other trials in Czechia

About this study

Official title: Long-term Safety and Tolerability of SAR236553 (REGN727) in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy: A Randomized, Double-Blind, Placebo-Controlled Study

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 long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT).

Secondary Objectives:

  • To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.
  • 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.
Read the detailed description

The maximum study duration was to be 89 weeks per participant, including a 3-week screening period, a 78-week randomized treatment period and 8-week follow-up period.

Being tested
Placebo (for alirocumab), Alirocumab, Lipid-Modifying Therapy (LMT)
Medical subject headings
Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo (for alirocumab)Drug

    Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.

  • AlirocumabDrug

    Also called SAR236553, REGN727, Praluent

    Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.

  • Lipid-Modifying Therapy (LMT)Drug

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

Study groups in NCT01507831
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo (for alirocumab) every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 78 weeks.
Receives: Drug: Placebo (for alirocumab); Drug: Lipid-Modifying Therapy (LMT)
AlirocumabExperimentalAlirocumab 150 mg Q2W added to stable LMT for 78 weeks.
Receives: Drug: Alirocumab; Drug: Lipid-Modifying Therapy (LMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Experienced Adverse Events (AEs)

    Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days).

    Measured: Up to 10 weeks after last study drug administration (maximum of 86 weeks)

Secondary outcomes (25)

  1. Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis

    Adjusted least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).

    Measured: From Baseline to Week 52

  2. Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis

    Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).

    Measured: From Baseline to Week 52

  3. Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis

    Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

    Measured: From Baseline to Week 52

  4. Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis

    Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).

    Measured: From Baseline to Week 52

  5. Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis

    Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

    Measured: From Baseline to Week 52

  6. Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis

    Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

    Measured: From Baseline to Week 52

  7. Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis

    Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).

    Measured: From Baseline to Week 52

  8. Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis

    Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

    Measured: From Baseline to Week 52

  9. Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis

    Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).

    Measured: From Baseline to Week 52

  10. Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis

    Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

    Measured: From Baseline to Week 52

  11. Percent Change From Baseline in Apo B at Week 12 - ITT Analysis

    Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

    Measured: From Baseline to Week 52

  12. Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis

    Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

    Measured: From Baseline to Week 52

  13. Percent Change From Baseline in Total-C at Week 12 - ITT Analysis

    Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

    Measured: From Baseline to Week 52

  14. Percentage of Very High Cardiovascular (CV) Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis

    Very high CV risk: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents or non- Familial Hypercholesterolemia (FH). High CV risk: heFH participants without CHD or CHD risk equivalents. CHD risk equivalent: peripheral arterial disease, ischemic stroke, moderate chronic kidney disease (estimated glomerular filtration rate, 30 to <60 ml/minute/1.73 m^2 of body-surface area), or diabetes mellitus plus 2 or more additional risk factors (hypertension; ankle-brachial index of ≤0.90; microalbuminuria, macroalbuminuria, or a urinary dipstick result of >2+ protein; preproliferative or proliferative retinopathy or laser treatment for retinopathy; or family history of premature CHD). Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in imputation model.

    Measured: Up to Week 52

  15. Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis

    Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).

    Measured: Up to Week 52

  16. Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis

    Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.

    Measured: Up to Week 52

  17. Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis

    Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 52 (i.e. up to 21 days after last injection).

    Measured: Up to Week 52

  18. Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis

    Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment were included in the imputation model.

    Measured: From Baseline to Week 52

  19. Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis

    Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

    Measured: From Baseline to Week 52

  20. Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis

    Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.

    Measured: From Baseline to Week 52

  21. Percent Change From Baseline in Apo A1 at Week 24 - ITT Analysis

    Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

    Measured: From Baseline to Week 52

  22. Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis

    Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.

    Measured: From Baseline to Week 52

  23. Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis

    Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

    Measured: From Baseline to Week 52

  24. Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis

    Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.

    Measured: From Baseline to Week 52

  25. Percent Change From Baseline in Apo A1 at Week 12 - ITT Analysis

    Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

    Measured: From Baseline to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,341 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01507831
Sponsor's protocol ID
LTS11717
Other IDs
2011-002806-59, U1111-1121-3928
Status last verified
Nov 2015
First submitted
6 Jan 2012
Last updated
22 Dec 2015
Data monitoring committee
Yes

Publications

  • Robinson JG, Farnier M, Krempf M, Bergeron J, Luc G, Averna M, Stroes ES, Langslet G, Raal FJ, El Shahawy M, Koren MJ, Lepor NE, Lorenzato C, Pordy R, Chaudhari U, Kastelein JJ; ODYSSEY LONG TERM Investigators. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1489-99. doi: 10.1056/NEJMoa1501031. Epub 2015 Mar 15.

    PubMed 25773378

  • 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.

    PubMed 34298554

  • 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.

    PubMed 30183102

  • 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.

    PubMed 28964736

  • 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.

    PubMed 28391886

  • 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.

    PubMed 27777279

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alirocumab and Lipid-Modifying Therapy (LMT) in people with Hypercholesterolemia, run by Sanofi at 320 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 320 sites in United States, United Kingdom, Germany, Canada, France and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Experienced Adverse Events (AEs) (time frame: Up to 10 weeks after last study drug administration (maximum of 86 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01507831, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2015.

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