AzTrials
AzTrials

ObesityPhase 3NCT06077864

A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)

A Phase 3 study testing survodutide in people with Obesity, run by Boehringer Ingelheim at 542 sites in 35 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

This study is open to adults who are at least 18 years old and have a body mass index (BMI) of 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
survodutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5,530 participants
Where
542 sitesin 35 countries
Study dates
20 Nov 2023to 30 Jun 2026
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years.
  • Body mass index (BMI) ≥27 kg/m2 at screening with established cardiovascular disease (CVD) and/or at least 2 weight-related complications or risk factors for CVD OR BMI ≥30 kg/m2 at screening with established CVD or chronic kidney disease (CKD), and/or at least 2 weight-related complications or risk factors for CVD.
  • Further inclusion criteria apply.

Who cannot join

  • Previous treatment with glucagon-like peptide-1 receptor (GLP-1R) agonists within 3 months before screening.
  • Type 1 diabetes.
  • Less than 3 months between the last dose of GLP-1R agonists and GLP-1R agonist/insulin/glucose-dependent insulinotropic polypeptide (GIP) combinations and screening.
  • Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction).
  • Further exclusion criteria apply.

Trial locations and contacts

542 sites in 35 countries.

542 sites in 35 countries

United States153 sites

  • Javara-Albany-67356

    Albany, Georgia, 31707

  • IMA Clinical Research Albuquerque

    Albuquerque, New Mexico, 87109

  • Amarillo Medical Specialists

    Amarillo, Texas, 79124

  • McFarland Clinic PC

    Ames, Iowa, 50010

  • Synexus - Anderson

    Anderson, South Carolina, 29621

  • Velocity Clinical Research-Anderson-69093

    Anderson, South Carolina, 29621

  • Domino's Farms

    Ann Arbor, Michigan, 48105

  • Javara Inc.-Annapolis-68997

    Annapolis, Maryland, 21401

  • Washington Center for Weight Management and Research, Inc.

    Arlington, Virginia, 22206

  • Endeavor Health Clinical Operations - Northwest Community Healthcare

    Arlington Heights, Illinois, 60005

  • Velocity Clinical Research, Austin

    Austin, Texas, 78759

  • Ascension Saint Agnes Heart Care

    Baltimore, Maryland, 21229

  • Heritage Valley Medical Group

    Beaver, Pennsylvania, 15009

  • Velocity Clinical Research - Binghamton

    Binghamton, New York, 13905

  • Cardiology P.C.

    Birmingham, Alabama, 35211

  • Proactive Clinical Research

    Boca Raton, Florida, 33431

  • Excel Medical Clinical Trials

    Boca Raton, Florida, 33434

  • Grace Research, LLC-Bossier City-51040

    Bossier City, Louisiana, 71111

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • Advanced Heart Care, LLC

    Bridgewater, New Jersey, 08807

  • Internal Medicine and Pediatric Associates of Bristol, PC

    Bristol, Tennessee, 37620

  • Headlands Research - Brownsville

    Brownsville, Texas, 78526

  • Mercury Street Medical

    Butte, Montana, 59701

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania, 17011

  • Accellacare of Cary

    Cary, North Carolina, 27518

  • The Institute for Liver Health II DBA Arizona Clinical Trials

    Chandler, Arizona, 85225

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Javara-Charlotte-67884

    Charlotte, North Carolina, 28210

  • Chattanooga Research & Medicine, PLLC

    Chattanooga, Tennessee, 37404

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

  • Research by Design, LLC

    Chicago, Illinois, 60643

  • Velocity Clinical Research-Cincinnati-69044

    Cincinnati, Ohio, 45242

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

  • Peak Gastroenterology Associates-Colorado Springs-62256

    Colorado Springs, Colorado, 80907

  • Centricity Research Columbus Georgia Multispecialty

    Columbus, Georgia, 31904

  • Synexus Clinical Research-Columbus-69427

    Columbus, Ohio, 43212

  • Centricity Research-Columbus-68879

    Columbus, Ohio, 43213

  • Privia Medical Group Gulf Coast, PLLC

    Conroe, Texas, 77384

  • Nature Coast Clinical Research-Crystal River-62355

    Crystal River, Florida, 34429

  • Beautiful Minds Clinical Research Center

    Cutler Bay, Florida, 33157

  • Velocity Clinical Research-Dallas-69170

    Dallas, Texas, 75230

  • AMR Daphne

    Daphne, Alabama, 36526

  • The National Diabetes & Obesity Research Institute

    Diamondhead, Mississippi, 39525

  • Physicians' Research Options. LLC

    Draper, Utah, 84020

  • Aventiv Research Inc.-Dublin-62009

    Dublin, Ohio, 43016

  • Velocity Clinical Research-East Greenwich-68873

    East Greenwich, Rhode Island, 02818

  • Tekton Research-Edmond-68875

    Edmond, Oklahoma, 73013

  • AMR El Dorado

    El Dorado, Kansas, 67042

  • Skyline Medical Center

    Elkhorn, Nebraska, 68022

  • Medisphere Medical Research Center

    Evansville, Indiana, 47714

  • Seven Corners Medical Center

    Falls Church, Virginia, 22044

  • Prime Health and Wellness

    Fayette, Mississippi, 39069

  • Javara-Fayetteville-67354

    Fayetteville, Georgia, 30214

  • Elite Research Center, LLC

    Flint, Michigan, 48532

  • AMR Fort Myers

    Fort Myers, Florida, 33912

  • Covenant Metabolic Specialists, LLC - Fort Myers

    Fort Myers, Florida, 33912

  • Javara Inc. - Fort Worth

    Fort Worth, Texas, 76133

  • Methodist Physicians Clinic

    Fremont, Nebraska, 68025

  • Velocity Clinical Research-Gaffney-69046

    Gaffney, South Carolina, 29340

  • Healthy Heart Cardiology

    Grand Rapids, Michigan, 49546

  • Tribe Clinical Research LLC - Greenville

    Greenville, South Carolina, 29607

  • Velocity Clinical Research-Greenville-69045

    Greenville, South Carolina, 29615

  • Velocity Clinical Research-Gulfport-68930

    Gulfport, Mississippi, 39503

  • Velocity Clinical Research-Hallandale Beach-67888

    Hallandale, Florida, 33009

  • CMR of Greater New Haven, LLC

    Hamden, Connecticut, 06517

  • Heart Clinic of Hammond

    Hammond, Louisiana, 70403

  • Houston Research Institute

    Houston, Texas, 77079

  • Velocity Clinical Research-Huntington Park

    Huntington Park, California, 90255

  • Westside Center for Clinical Research

    Jacksonville, Florida, 32205

  • NSC Research Inc

    Johns Creek, Georgia, 30024

  • Johnson County ClinTrials

    Kansas City, Missouri, 64112

  • AMR Kansas City

    Kansas City, Missouri, 64114

  • Clinical Investigation Specialists, Inc.-Kenosha-69111

    Kenosha, Wisconsin, 53144

  • Alliance for Multispecialty Research, LLC-Knoxville-69693

    Knoxville, Tennessee, 37909

  • Accellacare of Knoxville-Knoxville-69135

    Knoxville, Tennessee, 37912

  • Accellacare of Knoxville-Knoxville-69714

    Knoxville, Tennessee, 37938

  • Velocity Clinical Research, San Diego

    La Mesa, California, 91942

  • AMR Las Vegas

    Las Vegas, Nevada, 89119

  • Alliance for Multispecialty Research, LLC-Layton-69691

    Layton, Utah, 84041

  • Clinical Site Partners LLC

    Leesburg, Florida, 34748

  • NJ Heart LLC

    Linden, New Jersey, 07036

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72204

  • Velocity Clinical Research - Los Angeles

    Los Angeles, California, 90017

  • The Jones Center Clinical Research, LLC

    Macon, Georgia, 31210

  • Urban Family Practice Associates, PC

    Marietta, Georgia, 30067

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • Velocity Clinical Research-Medford-69053

    Medford, Oregon, 97504

  • Clinical Neuroscience Solutions, Inc-Memphis-65988

    Memphis, Tennessee, 38119

  • Flourish Research - Miami

    Miami, Florida, 33135

  • Verus Clinical Research Corporation

    Miami, Florida, 33135

  • AMR Mobile

    Mobile, Alabama, 36608

  • Mobile Heart Specialists, PC

    Mobile, Alabama, 36608

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • Accellacare-Mooresville-69123

    Mooresville, North Carolina, 28117

  • Clinical Research Associates, Inc

    Nashville, Tennessee, 37203

  • Centricity Research (New Bern)

    New Bern, North Carolina, 28562

  • AMR New Orleans

    New Orleans, Louisiana, 70119

  • Synexus Clinical Research US, Inc.

    New York, New York, 10017

  • AMR Newton

    Newton, Kansas, 67114

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23510

  • AMR Norman

    Norman, Oklahoma, 73069

  • Lynn Institute of Norman

    Norman, Oklahoma, 73072

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • South Oklahoma Heart Research Group

    Oklahoma City, Oklahoma, 73135

  • Research Integrity, LLC

    Owensboro, Kentucky, 42303

  • MD Medical Research

    Oxon Hill, Maryland, 20745

  • Center for Diabetes, Obesity and Metabolism

    Pembroke Pines, Florida, 33024

  • Tristar Clinical Investigations PC

    Philadelphia, Pennsylvania, 19114

  • Synexus-Pinellas Park-69294

    Pinellas Park, Florida, 33781

  • Preferred Primary Care Physicians-Pittsburgh-63932

    Pittsburgh, Pennsylvania, 15236

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905

  • East Coast Institute for Research, LLC-Saint Augustine-63032

    Saint Augustine, Florida, 32086

  • Synexus Clinical Research-Salt Lake City-69293

    Salt Lake City, Utah, 84106

  • IMA Clinical Research San Antonio

    San Antonio, Texas, 78229

  • Tekton Research-San Antonio-68916

    San Antonio, Texas, 78258

  • Javara Inc. and Privia Medical Group Gulf Coast, PLLC

    San Marcos, Texas, 78666

  • NorCal Endocrinology and Internal Medicine

    San Ramon, California, 94583

  • Velocity Clinical Research, Santa Ana

    Santa Ana, California, 92704

  • NorthBay Clinical Research, LLC

    Santa Rosa, California, 95405

  • Saratoga Clinical Research, LLC

    Saratoga Springs, New York, 12866

  • Javara-Savannah-67450

    Savannah, Georgia, 31406

  • Velocity Clinical Research, Seattle

    Seattle, Washington, 98105

  • Grace Research, LLC-Shreveport-64616

    Shreveport, Louisiana, 71105

  • Velocity Clinical Research-Spokane-69716

    Spokane, Washington, 99218

  • Clinvest Research LLC

    Springfield, Missouri, 65807

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141

  • Chrysalis Clinical Research

    St. George, Utah, 84790

  • Javara Inc.-Stephenville-68996

    Stephenville, Texas, 76401

  • Clinical Research Institute of Arizona, LLC

    Sun City West, Arizona, 85375

  • Lenus Research & Medical Group

    Sweetwater, Florida, 33172

  • Santos Research Center, Corp.

    Tampa, Florida, 33615

  • AMR Phoenix

    Tempe, Arizona, 85281

  • DM Clinical Research - Martin Diagnostic Clinic

    Tomball, Texas, 77375

  • Arizona Liver Health-Tucson-67516

    Tucson, Arizona, 85712

  • Velocity Clinical Research-Union-68888

    Union, South Carolina, 29379

  • Preferred Primary Care Physicians-Uniontown-69137

    Uniontown, Pennsylvania, 15401

  • Covenant Metabolic Specialists, LLC - Sarasota

    University Park, Florida, 34201

  • Velocity Clinical Research-Van Nuys-70286

    Van Nuys, California, 91405

  • Velocity Clinical Research, Waco

    Waco, Texas, 76710

  • IMA Clinical Research-Warren-69742

    Warren Township, New Jersey, 07059

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Allegiance Research Specialists

    Wauwatosa, Wisconsin, 53226

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50266

  • Velocity Clinical Research-West Jordan-69043

    West Jordan, Utah, 84088

  • Clinical Research Institute of Ohio, LLC

    Westlake, Ohio, 44145

  • AMR Clinical Wichita

    Wichita, Kansas, 67226

  • Selma Medical Associates, Winchester

    Winchester, Virginia, 22601

  • Wake Forest University Health Sciences-Winston-Salem-69719

    Winston-Salem, North Carolina, 27104

  • Yuma Clinical Trials

    Yuma, Arizona, 85364

Other trials in United States

China34 sites

  • Beijing Chao-Yang Hospital

    Beijing, 100020

  • Peking University First Hospital

    Beijing, 100034

  • Beijing Pinggu Hospital

    Beijing, 101200

  • The Second Hospital of Jilin University

    Changchun, 130041

  • Changzhou Second People's Hospital

    Changzhou, 213004

  • Second Affiliated Hospital Chongqing Medical University

    Chongqing, 400016

  • Hangzhou First People's Hospital

    Hangzhou, 310006

  • Forth Clinical Hospital of Harbin Medical University

    Harbin, 150599

  • The First Affiliated Hospital of University of South China

    Hengyang, 421001

  • Huai'an first people's hospital

    Huai'an, 223300

  • Huzhou Central Hospital

    Huzhou, 313000

  • Center Hospital of Jinan

    Jinan, 250013

  • Lishui Municipal Central Hospital

    Lishui, 323020

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, 471000

  • Nanchang People's Hospital

    Nanchang, 330008

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • Zhongda Hospital Southeast University

    Nanjing, 210009

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, 210011

  • Nanjing Jiangning Hospital

    Nanjing, 211100

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang, 473007

  • The First Affiliated Hospital of Ningbo University

    Ningbo, 315010

  • First Hospital of Qinhuangdao

    Qinhuangdao, 066099

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, 200032

  • Tongren hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200051

  • Shanghai Municipal Hospital of Traditional Chinese Medicine

    Shanghai, 200071

  • Shanghai Fifth People's Hospital affiliated to Fudan University

    Shanghai, 200240

  • Shanghai Pudong New District People's Hospital

    Shanghai, 201200

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, 050000

  • Suzhou Science & Technology Town Hospital

    Suzhou, 215000

  • Shaanxi Provincial People's Hospital

    Xi'an, 1710068

  • First Affiliated Hospital of Xi'an JiaoTong University

    Xi'an, 710061

  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an, 710077

  • Xianyang Hospital of Yan'an University

    Xianyang, 712000

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, 212013

Other trials in China

Poland34 sites

  • Uniwersytecki Szpital Kliniczny W Bialymstoku

    Bialystok, 15-276

  • Trial Medica

    Bialystok, 15-481

  • Centrum Medyczne Intercor Sp. z o.o.

    Bydgoszcz, 85-605

  • NZOZ Medical Center KERmed

    Bydgoszcz, 85231

  • Synexus Poland, Branch in Czestochowa

    Częstochowa, 42202

  • Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk

    Gdansk, 80-382

  • Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia

    Gdynia, 81-537

  • Przychodnie Grudziadz sp.zo.o

    Grudziądz, 86300

  • Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice

    Katowice, 40-040

  • Silmedic Sp. z o.o.

    Katowice, 40-282

  • Vita Longa Sp. z o.o.

    Katowice, 40-748

  • Salvia Lekston I Madej Sp. J.

    Katowice, 40772

  • Diab-Endo-Met Medical Center

    Krakow, 31-261

  • Unicardia Specialist Medical Center

    Krakow, 31271

  • Synexus Lodz Medical Center

    Lodz, 90127

  • Med-Gastr Medical Center

    Lodz, 91-034

  • Clinical Best Solutions

    Lublin, 20-011

  • Ekamed Sp. z o.o.

    Lublin, 20718

  • Futuremeds Sp. z o.o. Olsztyn

    Olsztyn, 10 165

  • Synexus Poland, Branch in Poznan

    Poznan, 60-702

  • Metabolic Health Center Pawel Bogdanski

    Poznan, 60589

  • Private Practice Dr. Ewa Krzyzagorska

    Poznan, 61-655

  • Padre Pio Regional Hospital in Przemysl

    Przemyśl, 37-700

  • Centrum Medyczne Medyk

    Rzeszów, 35-055

  • Velocity Nova Sp. z.o.o.

    Skierniewice, 96100

  • NZOZ Procordis, Cardiology Research Center of Sopot

    Sopot, 81-717

  • Velocity Nova Sp z o.o.

    Staszów, 28200

  • DC-MED

    Swidnica, 58-100

  • Clinical Best Solutions Sp. z o.o. S.K.

    Warsaw, 00710

  • NBR Polska

    Warsaw, 00710

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

    Warsaw, 02-507

  • Centrum Medyczne Synexus

    Warsaw, 02-672

  • ETG Warszawa

    Warsaw, 02-677

  • Synexus Poland, Branch in Wroclaw

    Wroclaw, 50-381

Other trials in Poland

Canada25 sites

  • Centricity Research (Brampton)

    Brampton, Ontario, L6S 0C6

  • Richmond Road Diagnostic & Treatment Centre

    Calgary, Alberta, T2T 5C7

  • C-ENDO Diabetes & Endocrinology Clinic

    Calgary, Alberta, T2V 4J2

  • Cambridge Cardiac Care Centre

    Cambridge, Ontario, N1R 6V6

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9

  • Centricity Research (Etobicoke)

    Etobicoke, Ontario, M9R 4E1

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Premier Clinical Trial Network

    Hamilton, Ontario, L8L 5G4

  • The Wharton Medical Clinic Clinical Trials Inc.

    Hamilton, Ontario, L8L 5G8

  • Western Centre for Public Health & Family Medicine (LHRI)

    London, Ontario, N6G 2M1

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Montreal General Hospital - McGill University Health Centre

    Montreal, Quebec, H3G 1A4

  • Centricity Research (Oshawa)

    Oshawa, Ontario, L1J 2K9

  • Recherche Clinique Sigma Inc.

    Québec, G1G 5X1

  • CARe Clinic (Red Deer)

    Red Deer, Alberta, T4P 1K4

  • Bluewater Clinical Research

    Sarnia, Ontario, N7T 4X3

  • SMH Cardiology Clinical Trials Inc.

    Surrey, British Columbia, V3V 0C6

  • Centre de Medecine Metabolique de Lanaudiere

    Terrebonne, Quebec, J6X 4P7

  • Canadian Phase Onward Inc.

    Toronto, Ontario, M3J 0K2

  • Centricity Research (Bayview)

    Toronto, Ontario, M4G 3E8

  • Diabetes Heart Research Centre

    Toronto, Ontario, M6G 1M2

  • Diex Recherche (Trois-Rivieres)

    Trois-Rivières, Quebec, G9A 4P3

  • Victoria Heart Institute Foundation

    Victoria, British Columbia, V8R 1B2

  • Clinical Research Solutions Inc. (Waterloo)

    Waterloo, Ontario, N2T 0C1

  • Winnipeg Clinic

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

Japan24 sites

  • Meitetsu Hospital

    Aichi, Nagoya, 451-8511

  • Nagoya Kyoritsu Hospital

    Aichi, Nagoya, 454-0933

  • Chubu Rosai Hospital

    Aichi, Nagoya, 455-8530

  • Daido Clinic

    Aichi, Nagoya, 457-8511

  • Seikeikai New Tokyo Heart Clinic

    Chiba, Matsudo, 271-0077

  • Takagi Hospital

    Fukuoka, Okawa, 831-0016

  • Seino Internal Medicine Clinic

    Fukushima, Koriyama, 963-8851

  • Iryouhouijneiwakai Minamiakatsuka Clinic

    Ibaraki, Mito, 311-4153

  • Matsuba Clinic

    Kanagawa, Kawasaki, 212-0024

  • Sagamihara Kyodo Hospital

    Kanagawa, Sagamihara, 252-5188

  • Saiseikai Yokohamashi Nanbu Hospital

    Kanagawa, Yokohama, 234-0054

  • Takeshita Hospital

    Kochi, Kochi, 780-0863

  • Kyoto Okamoto Memorial Hospital

    Kyoto, Kuse-gun, 613-0034

  • Sato Hospital

    Miyagi, Sendai, 980-0011

  • Urasoe General Hospital

    Okinawa, Urasoe, 901-2102

  • Osaka Keisatsu Hospital

    Osaka, Osaka, 543-8922

  • Saiseikai Kawaguchi Hospital

    Saitama, Kawaguchi, 332-8558

  • Koshigaya Municipal Hospital

    Saitama, Koshigaya, 343-8577

  • Saitama Sekishikai Hospital

    Saitama, Sayama, 350-1305

  • Sayama General Clinic

    Saitama, Sayama, 350-1305

  • Omihachiman Community Medical Center

    Shiga, Omihachiman, 523-0082

  • Minamino Cardiovascular Hospital

    Tokyo, Hachioji, 192-0918

  • NewHeart Watanabe Institute

    Tokyo, Suginami-ku, 168-0065

  • Saiseikai Wakayama Hospital

    Wakayama, Wakayama, 640-8158

Other trials in Japan

United Kingdom21 sites

  • University Hospital Monklands

    Airdrie, ML6 0JS

  • Antrim Area Hospital

    Antrim, BT41 2RL

  • Waterloo Medical Centre

    Blackpool, FY4 3AD

  • Synexus - Cardiff

    Cardiff, CF15 9SS

  • Synexus - Lancashire

    Chorley, PR7 7NA

  • Ninewells Hospital & Medical School

    Dundee, DD1 9SY

  • Wellcome Trust Clinical Research Facility, Edinburgh

    Edinburgh, EH4 2XU

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Synexus - Glasgow

    Glasgow, ML4 3NJ

  • Synexus - Hexham

    Hexham, NE46 1QJ

  • Leicester General Hospital

    Leicester, LE5 4PW

  • Lincoln County Hospital

    Lincoln, LN2 5QY

  • Synexus - Merseyside

    Liverpool, L22 0LG

  • William Harvey Research Limited

    London, EC1M 6BQ

  • Altnagelvin Area Hospital

    Londonderry, BT47 6SB

  • Manchester Royal Infirmary

    Manchester, M13 9WL

  • Synexus - Manchester

    Manchester, M15 6SE

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE2 4HH

  • FutureMeds - Newcastle

    Newcastle upon Tyne, NE6 1SG

  • Swansea University Medical School

    Swansea, SA2 8PP

  • University Hospital Wishaw

    Wishaw, ML2 0QB

Other trials in United Kingdom

Germany20 sites

  • Universitätsklinikum Aachen, AöR

    Aachen, 52074

  • Velocity Clinical Research Germany GmbH, Berlin

    Berlin, 10787

  • DRK Kliniken Berlin Köpenick

    Berlin, 12559

  • Synexus Clinical Research GmbH, Berlin

    Berlin, 12627

  • Universitätsklinikum Köln (AöR)

    Cologne, 50937

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Synexus Clinical Research GmbH, Frankfurt

    Frankfurt, 60313

  • IKF Pneumologie GmbH & Co. KG

    Frankfurt, 60596

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • St. Josefskrankenhaus Heidelberg

    Heidelberg, 69115

  • Universität des Saarlandes

    Homburg, 66421

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Synexus Clinical Research GmbH, Leipzig

    Leipzig, 04103

  • Velocity Clinical Research Germany GmbH, Leipzig

    Leipzig, 04177

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Westfälische Wilhelms-Universität Münster

    Münster, 48149

  • CEDA Research GBR

    Pohlheim, 35415

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

Hungary15 sites

  • Lausmed Kft.

    Baja, 6500

  • Obudai Egeszegugyi Centrum Kft.

    Budapest, 1036

  • Synexus Hungary Healthcare Service Ltd.

    Budapest, 1036

  • Central Hospital of Northern Pest - Military Hospital

    Budapest, 1062

  • Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet

    Budapest, 1106

  • Semmelweis University

    Budapest, 1122

  • University Debrecen Hospital

    Debrecen, 4032

  • Erzsebet Nursing Home

    Gödöllő, 2100

  • Synexus Hungary Healthcare Service Ltd

    Gyula, 5700

  • Trial Pharma Kft

    Gyula, 5700

  • BKS Research Ltd

    Hatvan, 3000

  • Studium Egeszseghaz Kft.

    Kalocsa, 6300

  • Somogy County Kaposi Mor Teaching Hospital

    Kaposvár, 7400

  • Obudai Egeszegugyi Centrum

    Zalaegerszeg, 8900

  • SYNEXUS Hungary Health Care Services Ltd-Zalaegerszeg-69406

    Zalaegerszeg, 8900

Other trials in Hungary

South Korea15 sites

  • Pusan National University Hospital

    Busan, 602-739

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Keimyung University Dongsan Hospital

    Daegu, 42601

  • Yeungnam University Medical Center

    Daegu, 705-717

  • Chungnam National University Hospital

    Daejeon, 35015

  • Chonnam National University Hospital

    Gwangju, 61469

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Kyung Hee University Hospital

    Seoul, 02447

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278

  • Gangnam Severance Hospital

    Seoul, 06273

  • Korea University Guro Hospital

    Seoul, 08308

  • Yonsei University Wonju Severance Christian Hospital

    Wonju-si, Gangwon State, 26426

Other trials in South Korea

Spain15 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Universitario de Badajoz

    Badajoz, 06080

  • Centro Médico Teknon

    Barcelona, 08022

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital de Basurto

    Bilbao, 48013

  • Hospital Universitari de Girona Doctor Josep Trueta

    Girona, 17007

  • Hospital Universitario San Cecilio

    Granada, 18016

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Quirónsalud Madrid

    Pozuelo de Alarcón, 28223

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Complexo Hospitalario Universitario De Santiago

    Santiago de Compostela, 15706

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010

  • Hospital Dr. Peset

    Valencia, 46017

Other trials in Spain

Argentina14 sites

  • Centro de Investigaciones Metabolicas (CINME)

    Buenos Aires, C1056ABJ

  • CEDIC - Centro de Investigacion Clinica

    CABA, C1060ABN

  • Mautalen- Salud e Investigacion

    CABA, C1128AAF

  • Centro Medico Dra Laura Maffei

    Ciudad Autonoma Buenos Aires, C1425AGC

  • Glenny Corp. S.A. Bioclinica Argentina

    Ciudad Autonoma Buenos Aires, C1430CKE

  • Centro Medico Viamonte

    Ciudad Autonoma de Bs As, C1120AAC

  • Sanatorio Güemes

    Ciudad Autonoma de Bs As, C1180AAX

  • Consultorio de Investigacion Clinica EMO SRL

    Ciudad Autonoma de Buenos Aire, 1405

  • CIPREC

    Ciudad Autonoma de Buenos Aire, 1602

  • CIDIM - Centro Integral de Diagnostico por Imagenes Marchegiani

    Córdoba, X5000AVE

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata, 7600

  • Instituto de Investigaciones Clinicas Mar del Plata

    Mar del Plata, B7600FZN

  • Hospital Privado - Centro Medico de Cordoba S.A.

    Parque Velez Sarsfield, X5016KEH

  • CEMEDIC - Centro de Especialidades Medicas

    Villa Luro, 1407

Other trials in Argentina

Bulgaria14 sites

  • MHAT "Yuliya Vrevska" EOOD, Byala

    Byala, 7100

  • MHAT - Dobrich, AD

    Dobrich, 9300

  • Multy profile hospital for active treatment Sv.Ivan Rilski

    Dupnitsa, 2600

  • Multiprofile Hospital for Active Treatment Trimontsium OOD

    Plovdiv, 4000

  • MHAT "St. Caridad"

    Plovdiv, 4004

  • Multy Profile Hospital for active treatment Hadzhi Dimirar

    Sliven, 8800

  • Diagnostic & Consultancy Center "Ascendent", Sofia

    Sofia, 1202

  • Alexandrovska University Hospital

    Sofia, 1431

  • Diagnostic Consultative Center Alexandrovska

    Sofia, 1431

  • UMHAT "Tsaritsa Yoanna-ISUL" EAD

    Sofia, 1527

  • ASOMHIDC - Individual practice "Cardio Tonus" EOOD

    Sofia, 1582

  • Medical Center Synexus Sofia EOOD

    Sofia, 1784

  • Medical Center Berbatov

    Yambol, 8600

  • MHAT St Panteleimon

    Yambol, 8600

Other trials in Bulgaria

Brazil13 sites

  • Hospital Universitário João de Barros Barreto

    Belém, 66073-005

  • L2IP -Instituto de Pesquisas Clínicas Ltda.

    Brasília, 70200-730

  • Chronos Pesquisa Clinica

    Brasília, 72145-450

  • Cline Research Center

    Curitiba, 81520-060

  • Instituto de Estudos e Pesquisas Clínicas IEP-CE

    Fortaleza, 60160-230

  • Universidade Federal do Rio Grande do Sul

    Porto Alegre, 90430-001

  • Instituto Brasil de Pesquisa Clinica (IBPClin)

    Rio de Janeiro, 20241-180

  • ISPEM - Instituto São Jose dos Campos em Pesquisas Medicas

    São José dos Campos, 12243-280

  • Irmandade da Santa Casa de Misericórdia de São Paulo - IPEC - Instituto de Pesquisa Clínica

    São Paulo, 01221-020

  • Cpquali Pesquisa Clinica Ltda

    São Paulo, 01228-000

  • BR Trials

    São Paulo, 01236-030

  • CEPIC - Centro Paulista de Investigacao Clinica e Servicos

    São Paulo, 04266-010

  • Hospital das Clinicas da Faculdade de Medicina da USP

    São Paulo, 05403-900

Other trials in Brazil

Czechia13 sites

  • St. Anna Hospital

    Brno, 656 91

  • DIKa centrum s.r.o.

    Havířov, 73601

  • Center for Osteoporosis Therapy

    Karlovy Vary, 360 17

  • Diabetology Krnov

    Krnov, 79401

  • Internal and Diabetes Clinic

    Náchod, 547 01

  • PreventaMed, s.r.o.

    Olomouc, 77900

  • University Hospital Ostrava

    Ostrava-Poruba, 708 52

  • Internal ambulance Dialine s.r.o.

    Pilsen, 301 00

  • Synexus Czech s.r.o.

    Prague, 120 00

  • General Faculty Hospital, Prague

    Prague, 128 08

  • OB Klinika

    Prague, 130 00

  • Institute for Clinical and Experimental Medicine-Prague-66083

    Prague, 140 21

  • ResTrial s.r.o.

    Prague, 181 00

Other trials in Czechia

Turkey (Türkiye)13 sites

  • Adana City Hospital

    Adana, 01220

  • Baskent University Hospital

    Adana, 01240

  • Akdeniz UTF Endokrinoloji ve Metabolizma Hastaliklari BD

    Antalya, 7058

  • Inonu Uni. Med. Fac., Battalgazi

    Battalgazi, 44280

  • Bursa Yuksek Ihtisas EAH

    Bursa, 16330

  • Istanbul Universitesi Istanbul Tip Fakultesi

    Çapa, 34390

  • Dicle Universitesi Tip Fakultesi

    Diyarbakır, 21100

  • Koc Universitesi Hastanesi

    Istanbul, 34010

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi-Istanbul-1433

    Istanbul, 34098

  • Acibadem Universitesi Atakent Hastanesi

    Istanbul, 34303

  • İstanbul Prof.Dr. Cemil Taşçıoğlu City Hospital

    Istanbul, 34384

  • Marmara Universitesi Tip Fakultesi

    Istanbul, 34899

  • Zonguldak Bulent Ecevit UTF

    Zonguldak, 67600

Other trials in Turkey (Türkiye)

Portugal12 sites

  • Hospital de Cascais Dr. José de Almeida

    Alcabideche, 2755-009

  • ULS da Região de Aveiro

    Aveiro, 3814-501

  • ULS de Braga, E.P.E

    Braga, 4710-243

  • CHUC - Centro Hospitalar e Universitario de Coimbra, EPE

    Coimbra, 3000-075

  • ULS do Alto Ave

    Guimarães, 4835-044

  • ULS de São José

    Lisbon, 1069-166

  • APDP - Associação Protectora dos Diabéticos de Portugal

    Lisbon, 1250-189

  • Hospital da Luz

    Lisbon, 1500-650

  • Cardiolima - Centro Diagnostico Cardio-pulmonar de Ponte de Lima, Lda.

    Ponte de Lima, 4990-029

  • ULS de Entre Douro e Vouga

    Santa Maria da Feira, 4520-211

  • UCARDIO

    Torres Novas, 2350-325

  • Hospital da Luz Arrábida

    Vila Nova de Gaia, 4400-346

Other trials in Portugal

Australia11 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Novatrials

    Charlestown, New South Wales, 2290

  • Victorian Heart Hospital

    Clayton, Victoria, 3168

  • Advara Heart Care-Joondalup-69073

    Joondalup, Western Australia, 6027

  • Advara Heart Care-Leabrook-69072

    Leabrook, South Australia, 5068

  • Southern Adelaide Diabetes & Endocrine services

    Oaklands Park, South Australia, 5046

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal North Shore Hospital-St Leonards-66471

    St Leonards, New South Wales, 2065

  • Momentum Clinical Research - Taringa

    Taringa, Queensland, 4068

  • The Boden Initiative

    The University of Sydney, New South Wales, 2006

  • Momentum Clinical Research Taringa

    Wellers Hill, Queensland, 4121

Other trials in Australia

Italy10 sites

  • Humanitas Gavazzeni

    Bergamo, 24125

  • Ospedale S.M. Goretti

    Latina, 04100

  • IRCCS MultiMedica

    Milan, 20100

  • Centro Cardiologico Monzino-IRCCS

    Milan, 20138

  • Policlinico "Paolo Giaccone"

    Palermo, 90127

  • Università Campus Bio-Medico - ROMA

    Roma, 00128

  • AOU Policlinico Umberto I

    Roma, 00161

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00195

  • A.O.U. Senese

    Siena, 53100

  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

    Torino, 10126

Other trials in Italy

Greece9 sites

  • General Hospital of Athens "Laiko"

    Athens, 11527

  • Attikon University Hospital

    Haidari-Athens, 12462

  • University General Hospital of Heraklion

    Heraklion, Crete, 71110

  • Univ. Gen. Hosp. of Ioannina

    Ioannina, 45 500

  • University General Hospital of Larissa

    Larissa, 415 00

  • Iatriko of Athens Group/ Iatriko of P. Faliro

    P. Faliro, 17562

  • Iatriko Psychikou

    Psychikó, 11525

  • Gen. Hosp. of Thessaloniki "Hippokation", Department of Endocrinology

    Thessaloniki, 546 42

  • University General Hospital of Thessaloniki AHEPA

    Thessaloniki, 54636

Other trials in Greece

Austria8 sites

  • Medical University of Graz

    Graz, 8036

  • Medical University of Innsbruck

    Innsbruck, 6020

  • Convent Hospital Barmherzige Brüder

    Linz, 4021

  • LKH Salzburg University Hospital

    Salzburg, 5020

  • Hospital Stockerau

    Stockerau, 2000

  • Klinik Landstrasse

    Vienna, 1030

  • Private Practice - Dr. Ursula Hanusch-Enserer

    Vienna, 1060

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

India8 sites

  • S.P. Medical College & Associated Group of Hospitals

    Bikaner, 334 003

  • Apollo Speciality Hospital

    Chennai, 600006

  • Kamalnayan Bajaj Hospital

    Chhatrapati Sambhajinagar, 431 010

  • LPS Institute of Cardiology

    Kanpur, 208002

  • Shrikrishna Hrudayalaya and Critical Care Centre

    Maharashtra, 440012

  • Batra Hospital and Medical Research Centre

    New Delhi, 110 062

  • Sir Gangaram Hospital

    New Delhi, 110060

  • Shri B.D. Mehta Mahavir Heart Institute

    Surat, 395001

Other trials in India

New Zealand7 sites

  • Optimal Clinical Trials

    Auckland, 1010

  • Pacific Clinical Research Network - Forte Christchurch

    Christchurch, 8013

  • Momentum Palmerston North

    Palmerston North, Migration Data, 4414

  • Middlemore Clinical Trials

    Papatoetoe, 2025

  • Pacific Clinical Research Network - Rotorua

    Rotorua, 3010

  • Momentum Clinical Research

    Waikanae, 5036

  • Momentum Kāpiti Coast

    Waikanae Beach, 5036

Other trials in New Zealand

Mexico6 sites

  • Medical Center Metas S.C.

    Chihuahua City, 31110

  • Instituto de Diabetes, Obesidad y Nutrición S.C.

    Cuernavaca, 62250

  • Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.

    Culiacán, 80230

  • CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc

    México, C.P. 11650

  • Clinica Omega Diabetes

    Mexico City, 06700

  • Cardiolink Clin Trials S.C.

    Monterrey, 64060

Other trials in Mexico

Slovakia6 sites

  • METABOL KLINIK s.r.o., Bratislava

    Bratislava, 811 08

  • MEDISPEKTRUM s.r.o., Bratislava

    Bratislava, 85101

  • Medical Group Kosice s.r.o

    Košice, 04001

  • IN-DIA s.r.o., Lucenec

    Lučenec, 984 01

  • Funkystuff s.r.o.

    Nové Zámky, 940 01

  • DIAB sro

    Rožňava, 04801

Other trials in Slovakia

Taiwan6 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Chia-Yi Christian Hospital

    Chia-Yi City, 40705

  • China Medical University Hospital

    Taichung, 404327

  • NCKUH

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10048

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan County, 333

Other trials in Taiwan

Denmark5 sites

  • Aarhus University Hospital

    Aarhus N, 8200

  • Copenhagen University Hospital, Rigshospitalet

    Copenhagen, 2100

  • Herlev and Gentofte Hospital

    Herlev, 2730

  • Regionshospitalet Gødstrup

    Herning, 7400

  • Hvidovre Hospital

    Hvidovre, 2650

Other trials in Denmark

Finland5 sites

  • CRST Helsinki Oy

    Helsinki, 00180

  • StudyCor Oy

    Jyväskylä, 40620

  • Terveystalo Pori Lääkäritalo

    Pori, 28100

  • Tampere University Hospital

    Tampere, 33520

  • Terveystalo Pulssi, Turku

    Turku, FI-20100

Other trials in Finland

Kazakhstan4 sites

  • Institute of Gastroenterology, Hepatology and Metabolism LLP

    Almaty, 050000

  • Academy of Preventive Medicine, Clinic "Vitalem"

    Almaty, 050013

  • Multidisciplinary City Hospital №1 of the Akimat of Astana

    Astana, 010000

  • National Research Medical Center (NNMC)

    Astana, 010001

Other trials in Kazakhstan

Netherlands4 sites

  • Rijnstate Hospital

    Arnhem, 6815 AD

  • Spaarne Ziekenhuis

    Haarlem, 2035 RC

  • Diakonessenhuis Utrecht

    Utrecht, 3582 KE

  • Maxima Medisch Centrum

    Veldhoven, 5504 DB

Other trials in Netherlands

Norway4 sites

  • Vestre Viken HF, Drammen Sykehus

    Drammen, 3004

  • Akershus Universitetssykehus HF

    Lørenskog, 1478

  • Sykehuset i Vestfold, Avd. Tønsberg

    Tønsberg, N-3116

  • St. Olavs Hospital, Universitetssykehuset i Trondheim

    Trondheim, 7030

Other trials in Norway

Saudi Arabia4 sites

  • King Fahad Specialist Hospital - Research Center

    Dammam, 31444

  • King AbdulAziz University Hospital

    Jeddah, 21589

  • King Faisal Specialist Hospital and Research Center

    Riyadh, 11211

  • King Saud Medical City

    Riyadh, 11623

Other trials in Saudi Arabia

Belgium3 sites

  • AZ Sint-Jan Brugge

    Bruges, 8000

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Hong Kong3 sites

  • Prince of Wales Hospital-Hong Kong-20715

    Hong Kong, 999077

  • Queen Mary Hospital

    Hong Kong, 999077

  • Tung Wah Hospital

    Hong Kong

Other trials in Hong Kong

Ireland2 sites

  • St. Vincent's University Hospital

    Dublin, D04 T6F4

  • University Hospital Galway

    Galway, H91 T861

Other trials in Ireland

Puerto Rico2 sites

  • Advanced Clinical Research

    Bayamón, 00959

  • Ponce School of Medicine/CAIMED Center

    Ponce, 00716

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Randomised, Double-blind, Parallel-group, Event-driven, Cardiovascular Safety Study With BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity With Established Cardiovascular Disease (CVD) or Chronic Kidney Disease, and/or at Least Two Weight-related Complications or Risk Factors for CVD

This study is open to adults who are at least 18 years old and have a body mass index (BMI) of 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Participants must have previously tried to lose weight by changing their diet.

The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight.

Read more

Participants are divided into 3 groups of almost equal size. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under the skin once a week. All participants also receive counselling on diet and physical activity.

Participants are in the study for up to 2 years and 3 months. During this time, it is planned that participants visit the study site up to 21 times and attend remote visits by video calls. During these visits, the doctors check participants' cardiovascular and overall health. The results are compared between survodutide and placebo groups. The study staff also takes note of any unwanted effects.

Conditions
Obesity
Being tested
survodutide, Placebo
Medical subject headings
Obesity

What participants receive

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

  • survodutideCombination product

    Also called BI 456906

    once weekly subcutaneous injection, pre-filled syringe

  • PlaceboCombination product

    once weekly subcutaneous injection, pre-filled syringe

Study groups in NCT06077864
Study groupRoleWhat they receive
survodutide 3.6 mgExperimentalNot described
Receives: Combination Product: survodutide
survodutide 6.0 mgExperimentalNot described
Receives: Combination Product: survodutide
PlaceboPlacebo comparatorNot described
Receives: Combination Product: Placebo

What is being measured

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

  1. Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate non-inferiority)

    Heart failure events (HFE) includes hospitalisation for heart failure (HHF), emergency room visit, urgent care visit, or urgent outpatient heart failure (HF) visit (5-point major adverse cardiac event (5P-MACE)) CV-Cardiovascular MI-Myocardial infarction

    Measured: up to Week 114

Secondary outcomes (27)

  1. Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, or non-fatal MI (3-point major adverse cardiac event (3P-MACE)) (to demonstrate non-inferiority)

    Measured: up to Week 114

  2. Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 72

    Measured: Baseline and at Week 72

  3. Absolute change in waist circumference (cm) from baseline to Week 72

    Measured: Baseline and at Week 72

  4. Absolute change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Week 72 in trial participants with HF at baseline

    KCCQ-TSCC scale score range is from 0 to 100 where low score means patient not doing well and higher score means patient doing better.

    Measured: At Baseline and at Week 72

  5. Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate superiority)

    Measured: up to Week 114

  6. Percentage change in body weight from baseline to Week 72

    Measured: Baseline and at Week 72

  7. Absolute change in diastolic blood pressure (DBP) (mmHg) from baseline to Week 72

    Measured: Baseline and at Week 72

  8. Absolute change in aspartate aminotransferase (AST) (U/L) from baseline to Week 72

    Measured: Baseline and at Week 72

  9. Absolute change in alanine aminotransferase (ALT) (U/L) from baseline to Week 72

    Measured: Baseline and at Week 72

  10. Absolute change in glycosylated haemoglobin A1c (HbA1c) (mmol/mol) from baseline to Week 72 in trial participants with type 2 diabetes mellitus (T2DM)

    Measured: Baseline and at Week 72

  11. Absolute change in HbA1c (%) from baseline to Week 72 in trial participants with T2DM

    Measured: Baseline and at Week 72

  12. Time to onset of T2DM in trial participants without T2DM at baseline

    Measured: up to Week 114

  13. Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, or ischaemia related coronary revascularisation (4-point major adverse cardiac event (4P-MACE))

    Measured: up to Week 114

  14. Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, or HFE (3P-MACE+ HFE)

    Measured: up to Week 114

  15. Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, or non-fatal MI (3P-MACE)

    Measured: up to Week 114

  16. Time to first occurrence of adjudicated CV death or adjudicated HFE

    Measured: up to Week 114

  17. Time to first occurrence of adjudicated CV death or adjudicated HHF

    Measured: up to Week 114

  18. Time to first occurrence of adjudicated HFE

    Measured: up to Week 114

  19. Time to adjudicated CV death

    Measured: up to Week 114

  20. Time to all-cause mortality

    Measured: up to Week 114

  21. Time to first occurrence of adjudicated non-fatal MI

    Measured: up to Week 114

  22. Time to first occurrence of adjudicated non-fatal stroke

    Measured: up to Week 114

  23. Time to first occurrence of adjudicated ischaemia related coronary revascularisation

    Measured: up to Week 114

  24. Achievement of body weight reduction ≥5% from baseline to Week 72

    Measured: Baseline and at Week 72

  25. Achievement of body weight reduction ≥10% from baseline to Week 72

    Measured: Baseline and at Week 72

  26. Achievement of body weight reduction ≥15% from baseline to Week 72

    Measured: Baseline and at Week 72

  27. A composite of death, number of adjudicated HFEs, time to first adjudicated HFE and change from baseline in KCCQ-TSS at 72 weeks assessed by the win ratio in trial participants with HF at baseline

    Win ratio will be assessed as below:

    The primary efficacy endpoint will be analyzed using the clinical benefit approach comparing every participant in the BI 456906 arm to every participant in the placebo arm to determine a winner.

    A winner in the pair-wise comparison has a delayed time to the occurrence of death; if that cannot be determined, a winner has fewer HFEs; if the number of HFEs is the same a winner has a delayed time to the occurrence of first HFE; if that rule does not determine a winner, a winner has a more favorable (less increase or more decrease) change in KCCQ-CSS between baseline and at 72 weeks, otherwise the pair will be recorded as tied. The estimated net benefit (win ratio is then calculated as the total number of wins in the BI 456906 group across all strata divided by the total number of losses) will be provided.

    KCCQ-TSCC scale score range is from 0 to 100 where low score means patient not doing well and higher score means patient doing better.

    Measured: At baseline and at 72 Weeks

Timeline

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

  1. First posted11 Oct 2023
  2. Study start20 Nov 2023
  3. Primary completion1 Jun 2026
  4. Study completion30 Jun 2026

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
5,530 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06077864
Sponsor's protocol ID
1404-0040
Other IDs
2022-502442-27-00, U1111-1289-0174
Status last verified
Oct 2026
First submitted
27 Sep 2023
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Publications

  • Kosiborod MN, Platz E, Wharton S, le Roux CW, Brueckmann M, Ajaz Hussain S, Unseld A, Startseva E, Kaplan LM; SYNCHRONIZE-CVOT Trial Committees and Investigators. Survodutide for the Treatment of Obesity: Rationale and Design of the SYNCHRONIZE Cardiovascular Outcomes Trial. JACC Heart Fail. 2024 Dec;12(12):2101-2109. doi: 10.1016/j.jchf.2024.09.004. Epub 2024 Oct 23.

    PubMed 39453356

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing survodutide in people with Obesity, run by Boehringer Ingelheim at 542 sites in 35 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 3 inclusion and 5 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 542 sites in United States, China, Poland, Canada, Japan and 30 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate non-inferiority) (time frame: up to Week 114). 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 NCT06077864, which also lists 1 linked publication.

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 29 Oct 2026.

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