Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
NCT ID: NCT06858839
Last Updated: 2025-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
3853 participants
INTERVENTIONAL
2025-03-12
2027-04-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Maridebart Cafraglutide High Dose
Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.
Maridebart Cafraglutide
Maridebart cafraglutide will be administered SC.
Maridebart Cafraglutide Medium Dose
Participants will receive maridebart cafraglutide medium dose SC for 72 weeks.
Maridebart Cafraglutide
Maridebart cafraglutide will be administered SC.
Maridebart Cafraglutide Low Dose
Participants will receive maridebart cafraglutide low dose SC for 72 weeks.
Maridebart Cafraglutide
Maridebart cafraglutide will be administered SC.
Placebo
Participants will receive placebo SC for 72 weeks.
Placebo
Placebo will be administered SC.
Interventions
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Maridebart Cafraglutide
Maridebart cafraglutide will be administered SC.
Placebo
Placebo will be administered SC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index ≥ 30 kg/m2 or ≥27 kg/m² to \< 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH).
* History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
Exclusion Criteria
* Obesity induced by other endocrinologic disorders.
* Self-reported change in body weight \> 5 kg within 90 days before screening.
* Family (first-degree relative\[s\]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
* History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
* History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
* Lifetime history of suicide attempt.
18 Years
99 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2024-515524-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20210181
Identifier Type: -
Identifier Source: org_study_id
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