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ACTIVE NOT RECRUITING
NCT06858839
PHASE3

Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.

Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

3853

Start Date

2025-03-12

Completion Date

2027-04-16

Last Updated

2025-10-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

Maridebart Cafraglutide

Maridebart cafraglutide will be administered SC.

DRUG

Placebo

Placebo will be administered SC.

Locations (243)

Pinnacle Research Group LLC

Anniston, Alabama, United States

Alliance For Multispecialty Research - Daphne

Daphne, Alabama, United States

Alliance for Multispecialty Research Mobile

Mobile, Alabama, United States

Avacare Foothills Research Center

Phoenix, Arizona, United States

Ark Clinical Research- Tustin

Fountain Valley, California, United States

Long Beach Clinical Trials Services Inc

Long Beach, California, United States

Ark Clinical Research- Long Beach

Long Beach, California, United States

Catalina Research Institute

Montclair, California, United States

Artemis Institute for Clinical Research

Riverside, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Apex Clinical Research

San Diego, California, United States

Southern California Clinical Research

Santa Ana, California, United States

Diablo Clinical Research

Walnut Creek, California, United States

Yale School of Medicine

New Haven, Connecticut, United States

Chase Medical Research LLC

Waterbury, Connecticut, United States

Indago Research and Health Center

Hialeah, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Clinical Neuroscience Solutions - Jacksonville

Jacksonville, Florida, United States

South Florida Wellness and Clinical Research Institute

Margate, Florida, United States

Optimus U Corporation

Miami, Florida, United States

Research Institute of South Florida

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Clinical Neuroscience Solutions - Orlando

Orlando, Florida, United States

Combined Research Orlando Phase I IV

Orlando, Florida, United States

Florida Institute for Clinical Research

Orlando, Florida, United States

Encore Medical Research of Weston LLC

Weston, Florida, United States

Center for Advanced Research and Education

Gainesville, Georgia, United States

Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group

Union City, Georgia, United States

East-West Medical Research

Honolulu, Hawaii, United States

Solaris Clinical Research

Meridian, Idaho, United States

Flourish Research - Great Lakes Clinical Trials

Chicago, Illinois, United States

Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie

Skokie, Illinois, United States

Evanston Premier Healthcare Research LLC

Skokie, Illinois, United States

Alliance for Multispecialty Research Newton

Newton, Kansas, United States

Louisville Metabolic and Atherosclerosis Research Center

Louisville, Kentucky, United States

Velocity Clinical Research - Baton Rouge

Baton Rouge, Louisiana, United States

Tandem Clinical Research - Marrero

Marrero, Louisiana, United States

Headlands Research - Detroit

Southfield, Michigan, United States

Prime Health and Wellness Sky Clinical Research Network Group

Fayette, Mississippi, United States

Alliance for Multispecialty Research - Kansas City

Kansas City, Missouri, United States

Palm Research Center Inc

Las Vegas, Nevada, United States

Vector Clinical Trials

Las Vegas, Nevada, United States

Rochester Clinical Research

Rochester, New York, United States

Velocity Clinical Research- Binghamton

Vestal, New York, United States

Accellacare of Hickory

Hickory, North Carolina, United States

Carolina Research Center Inc

Shelby, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Clinical Trial Investigator Clinical Research Center

Cincinnati, Ohio, United States

Velocity Clinical Research - Cincinnati

Cincinnati, Ohio, United States

Alliance for Multispecialty Research - Norman

Norman, Oklahoma, United States

Capital Area Research LLC

Newport, Pennsylvania, United States

Velocity Clinical Research - Providence

East Greenwich, Rhode Island, United States

Tribe Clinical Research LLC Dba Mountain View Clinical Research

Greenville, South Carolina, United States

New Phase Research and Development

Knoxville, Tennessee, United States

Accellacare US Inc., d/b/a Accellacare of Knoxville

Knoxville, Tennessee, United States

Elligo Clinical Research Center

Austin, Texas, United States

Cedar Health Research, LLC

Dallas, Texas, United States

Epic Medical Research - Texas

DeSoto, Texas, United States

Great Lakes Research Institute El Paso Research

El Paso, Texas, United States

Cedar Health Research, LLC

Euless, Texas, United States

Juno Research LLC

Houston, Texas, United States

Biopharma Informatic, LLC

Houston, Texas, United States

Juno Research LLC

Houston, Texas, United States

Southern Endocrinology Associates PA

Mesquite, Texas, United States

Great Lakes Research Institute - McAllen Research

Pharr, Texas, United States

Clinical Trials of Texas

San Antonio, Texas, United States

Sugar Lakes Family Practice

Sugar Land, Texas, United States

Pantheon Clinical Research

Bountiful, Utah, United States

Alliance for Multispecialty Research Layton Research Center

Layton, Utah, United States

Chrysalis Clinical Research, LLC

St. George, Utah, United States

Washington Center for Weight Management and Research, Inc

Arlington, Virginia, United States

Health Research of Hampton Roads

Newport News, Virginia, United States

Selma Medical Associates

Winchester, Virginia, United States

Allegiance Research Specialists

Milwaukee, Wisconsin, United States

Cedic - Centro de Investigacion Clinica

CABA, Buenos Aires, Argentina

Centro Medico Viamonte

CABA, Buenos Aires, Argentina

Cemedic Centro de Especialidades Medicas

CABA, Buenos Aires, Argentina

Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

CABA, Buenos Aires, Argentina

Consultorios Medicos Dr Besada

CABA, Buenos Aires, Argentina

Fundacion Respirar

CABA, Buenos Aires, Argentina

Cinme - Centro de Investigaciones Metabolicas

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Ciprec - Centro de Investigacion y Prevencion Cardiovascular

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Emeritus Research Sydney

Botany, New South Wales, Australia

Novatrials

Charlestown, New South Wales, Australia

Canopy Clinical Sutherland

Miranda, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Canopy Clinical Wollongong

Wollongong, New South Wales, Australia

Logan Hospital

Meadowbrook, Queensland, Australia

Fusion Clinical Research

Norwood, South Australia, Australia

Southern Adelaide Diabetes and Endocrine Services

Oaklands Park, South Australia, Australia

Emeritus Research Camberwell

Camberwell, Victoria, Australia

Austin Health, Heidelberg Repatriation Hospital

Heidelberg West, Victoria, Australia

Canopy Clinical Altona North

North Altona, Victoria, Australia

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Algemeen Ziekenhuis Groeninge - Campus Kennedylaan

Kortrijk, Belgium

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Belgium

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, Belgium

Algemeen Ziekenhuis Sint-Maarten

Mechelen, Belgium

Centres Hospitaliers Universitaires HELORA - Hôpital de Mons - Site Constantinople

Mons, Belgium

tlc Diabetes and Endocrinology

Surrey, British Columbia, Canada

Wharton Medical Clinic

Hamilton, Ontario, Canada

North York Diagnostic and Cardiac Centre

North York, Ontario, Canada

Centricity Research Oshawa Multispecialty

Oshawa, Ontario, Canada

Heart Health Institute Research Incorporated

Scarborough Village, Ontario, Canada

Curans Heart Center

Thunder Bay, Ontario, Canada

Centricity Research Toronto

Toronto, Ontario, Canada

Diabetes Heart Research Centre

Toronto, Ontario, Canada

Ecogene-21

Chicoutimi, Quebec, Canada

Institut Universitaire de cardiologie et de pneumologie de Quebec

Québec, Quebec, Canada

CardioVasc HR Incorporated

Saint-Jean-sur-Richelieu, Quebec, Canada

Centre de Medecine Metabolique de Lanaudiere

Terrebonne, Quebec, Canada

Medicus Services sro

Brandýs nad Labem, Czechia

Fakultni nemocnice Brno

Brno, Czechia

Endohope Havirov sro

Havířov, Czechia

PreventaMed sro

Olomouc, Czechia

CCR Ostrava sro

Ostrava, Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Ob klinika as

Prague, Czechia

Institut klinicke a experimentalni mediciny

Prague, Czechia

Endohope klinika sro

Prague, Czechia

Endokrinologie Cerny Most sro

Prague, Czechia

Sanos Gandrup

Gandrup, Denmark

Gentofte Hospital

Hellerup, Denmark

Sanos Clinic

Herlev, Denmark

Steno Diabetes Center Copenhagen

Herlev, Denmark

Regionshospitalet Godstrup

Herning, Denmark

Hvidovre Hospital

Hvidovre, Denmark

Obesity Research Unit

Helsinki, Finland

Health Step Finland

Kuopio, Finland

Oulu University Hospital

Oulu, Finland

Universitaetsklinikum Aachen

Aachen, Germany

Kardiologische Praxis Dr med Wolfgang Jungmair

Bad Homburg, Germany

Universitaets-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Germany

Diabetespraxis Bad Mergentheim

Bad Mergentheim, Germany

Universitaetsklinikum der Ruhr-Universitaet Bochum

Bad Oeynhausen, Germany

Charite - Universitaetsmedizin Berlin, Campus Mitte

Berlin, Germany

Velocity Clinical Research GmbH

Berlin, Germany

Diabetespraxis Dr. Hermann Braun

Berlin, Germany

Mvz am Bahnhof Spandau

Berlin, Germany

Universitaetsklinikum Dresden

Dresden, Germany

Zentrum fuer Klinische Studien Suedbrandenburg GmbH

Elsterwerda, Germany

InnoDiab Forschung

Essen, Germany

Praxis am Markt Dr. Bernd Becker

Essen, Germany

Schwerpunktpraxis fuer Diabetes, Gefaess- & Ernaehrungsmedizin

Falkensee, Germany

ClinPhenomics CVC GmbH

Frankfurt am Main, Germany

Diabeteszentrum Hamburg West

Hamburg, Germany

Endokrinologikum Hamburg

Hamburg, Germany

Diabetologische Schwerpunktpraxis Hohenmoelsen

Hohenmölsen, Germany

Braun Ambulantes Herzzentrum Kassel

Kassel, Germany

Universitaetsklinikum Leipzig

Leipzig, Germany

AmBeNet GmbH

Leipzig, Germany

Universitaetsklinikum Schleswig-Holstein - Luebeck

Lübeck, Germany

Marienhaus Klinikum Mainz

Mainz, Germany

Kardiologische Praxis Doktor Jens Taggeselle

Markkleeberg, Germany

Centrum für Diagnostik und Gesundheit

München, Germany

Zentrum fuer Diabtes und Gefaesskrankheiten im Franziskus Carré Muenster

Münster, Germany

Praxis Segner - Dr. Braun - Kirsch

Oberwürzbach, Germany

Red-Institut GmbH

Oldenburg, Germany

Gemeinschaftspraxis Prof Jacob/ Dr Jacob

Villingen-Schwenningen, Germany

Zentrum fuer klinische Forschung Allgaeu Oberschwaben

Wangen, Germany

IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola

Bologna, Italy

Universita degli Studi Gabriele D Annunzio di Chieti e Pescara

Chieti, Italy

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

IRCCS Centro Cardiologico Monzino

Milan, Italy

Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco

Milan, Italy

Ospedale Civico, Di Cristina e Benfratelli

Palermo, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Fondazione Policlinico Tor Vergata

Roma, Italy

Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic

Yokohama, Kanagawa, Japan

Doujin Memorial Foundation, Meiwa Hospital

Chiyoda-ku, Tokyo, Japan

Tokyo Asbo Clinic

Chuo-ku, Tokyo, Japan

Medical Corp Seikoukai New Medical Research System Clinic

Hachioji-shi, Tokyo, Japan

Medical Corporation AOT Shinagawa Strings Clinic

Minato-ku, Tokyo, Japan

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, Japan

Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic

Suginami-ku, Tokyo, Japan

Gabinet Leczenia Otylosci i Chorob Dietozaleznych dr hab n med Lucyna Ostrowska

Bialystok, Poland

Kresmed Spolka z Ograniczona Odpowiedzialnoscia

Bialystok, Poland

Etg Lublin Spzoo

Dębica, Poland

Futuremeds Spolka z ograniczona odpowiedzialnoscia

Gdynia, Poland

Uniwersyteckie Centrum Kliniczne im Prof K Gibinskiego Slaskiego UM w Katowicach

Katowice, Poland

Salvia-Lekston i Madej Spolka Jawna

Katowice, Poland

Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

Lodz, Poland

Ekamed Spolka z Ograniczona Odpowiedzialnoscia

Lublin, Poland

Centrum Zdrowia Metabolicznego Pawel Bogdanski

Poznan, Poland

Clinical Research Center Spzoo Medic-R Spolka Komandytowa

Poznan, Poland

Futuremeds Spolka z ograniczona odpowiedzialnoscia

Warsaw, Poland

Clinical Best Solutions Sp zoo Spolka komandytowa

Warsaw, Poland

Ponce Medical School Foundation Inc

Ponce, Puerto Rico

Puerto Rico Medical Research Inc.

Ponce, Puerto Rico

Latin Clinical Trial Center

San Juan, Puerto Rico

Wellness Clinical Research Vega Baja

Vega Baja, Puerto Rico

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, South Korea

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

The Catholic University of Korea Bucheon St Marys Hospital

Bucheon, Gyeonggi-do, South Korea

Dong-A University Hospital

Busan, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Yeungnam University Medical Center

Daegu, South Korea

Daejeon Eulji Medical Center, Eulji University

Daejeon, South Korea

Konyang University Hospital

Daejeon, South Korea

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

KyungHee University Gangdong Hospital

Seoul, South Korea

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, South Korea

The Catholic University of Korea Yeouido St Marys Hospital

Seoul, South Korea

Ajou University Hospital

Suwon-si Gyeonggi-do, South Korea

Pusan National University Yangsan Hospital

Yangsan-si, Gyeongsangnam-do, South Korea

Centro Periferico de Especialidades Bola Azul

Almería, Andalusia, Spain

Hospital Vithas Sevilla

Castilleja de la Cuesta, Andalusia, Spain

Hospital Infanta Elena

Huelva, Andalusia, Spain

Hospital Virgen del Camino

Sanlúcar de Barrameda, Andalusia, Spain

Nuevas Tecnologias en Diabetes y Endocrinologia

Seville, Andalusia, Spain

Hospital Quironsalud Infanta Luisa

Seville, Andalusia, Spain

Hospital Medico Quirurgico San Rafael

A Coruña, Galicia, Spain

Clinica Ruber SA

Pozuelo de Alarcón, Madrid, Spain

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Clinica Juaneda

Palma, Spain

Hospital Universitario Doctor Peset

Valencia, Spain

Universitaetsspital Basel

Basel, Switzerland

Hopitaux Universitaires de Geneve

Geneva, Switzerland

Kantonsspital Sankt Gallen

Sankt Gallen, Switzerland

Stoffwechselzentrum Sankt Gallen

Sankt Gallen, Switzerland

Universitaetsspital Zuerich

Zurich, Switzerland

Ormeau Clinical Trials Ltd

Belfast, United Kingdom

FutureMeds Birmingham

Birmingham, United Kingdom

Layton Medical Centre

Blackpool, United Kingdom

Waterloo Medical Centre

Blackpool, United Kingdom

Southmead Hospital

Bristol, United Kingdom

The Rame Group Practice

Cornwall, United Kingdom

Staploe Medical Centre

Ely, United Kingdom

FutureMeds Glasgow

Glasgow, United Kingdom

Hull Royal Infirmary

Hull, United Kingdom

NIHR Leicestershire & Northamptonshire Commercial Research Delivery Centre

Leicester, United Kingdom

Aintree University Hospital

Liverpool, United Kingdom

FutureMeds Newcastle

Newcastle upon Tyne, United Kingdom

Atlantic Medical Group

Penzance, United Kingdom

Clifton Medical Centre

Rotherham, United Kingdom

Ashfields Primary Care Centre

Sandbach, United Kingdom