Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
NCT ID: NCT06858878
Last Updated: 2025-12-31
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
1105 participants
INTERVENTIONAL
2025-03-17
2027-04-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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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 adminstered SC.
Maridebart Cafraglutide Medium Dose
Participants will receive maridebart cafraglutide medium dose SC for 72 weeks.
Maridebart cafraglutide
Maridebart cafraglutide will be adminstered SC.
Maridebart Cafraglutide Low Dose
Participants will receive maridebart cafraglutide low dose SC for 72 weeks.
Maridebart cafraglutide
Maridebart cafraglutide will be adminstered SC.
Placebo
Participants will receive placebo SC for 72 weeks.
Placebo
Placebo will be adminstered SC.
Interventions
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Maridebart cafraglutide
Maridebart cafraglutide will be adminstered SC.
Placebo
Placebo will be adminstered SC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index ≥ 27 kg/m\^2.
* History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
* Diagnosis of T2DM.
Exclusion Criteria
* Self-reported change in body weight \> 5 kg within 90 days before screening.
* Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment.
* Obesity induced by other endocrinologic disorders.
* 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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Alliance for Multispecialty Research Mobile
Mobile, Alabama, United States
Gilbert Center for Family Medicine
Gilbert, Arizona, United States
Desert Clinical Research
Mesa, Arizona, United States
Avacare Foothills Research Center
Phoenix, Arizona, United States
San Fernando Valley Health Institute
Canoga Park, California, United States
Core Healthcare Group
Cerritos, California, United States
Velocity Clinical Research Chula Vista
Chula Vista, California, United States
Headlands Research California
Escondido, California, United States
Paradigm Clinical Research
Modesto, California, United States
Flourish Research
Northridge, California, United States
University of California Irvine
Orange, California, United States
Empire Clinical Research
Pomona, California, United States
Infinity Clinical Trials
San Diego, California, United States
Greenwich Clinical Trials
Riverside, Connecticut, United States
Indago Research and Health Center
Hialeah, Florida, United States
Optimus U Corporation
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
San Marcus Research Clinic Inc
Miami Lakes, Florida, United States
Florida Institute for Clinical Research
Orlando, Florida, United States
Encore Medical Research of Weston LLC
Weston, Florida, United States
Conquest Research - Winter Park
Winter Park, Florida, United States
Alliance For Multispecialty Research - Oak Brook
Oak Brook, Illinois, United States
Alliance for Multispecialty Research, LLC - Park Ridge
Park Ridge, Illinois, United States
Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie
Skokie, Illinois, United States
Indiana Medical Research Institute
Merrillville, Indiana, United States
Iowa Diabetes Research
West Des Moines, Iowa, United States
Alliance for Multispecialty Research Newton
Newton, Kansas, United States
Alliance for Multispecialty Research LLC
Wichita, Kansas, United States
Advanced Internal Medicine
Paducah, Kentucky, United States
Ima Clinical Research- Monroe
Monroe, Louisiana, United States
Annapolis Internal Medicine, LLC
Annapolis, Maryland, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
International Diabetes Center - HealthPartners Institute
Minneapolis, Minnesota, 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
Sparks, Nevada, United States
Premier Research
Trenton, New Jersey, United States
Albany Medical College
Albany, New York, United States
Asheville Clinical Research
Asheville, North Carolina, United States
Physicians East
Greenville, North Carolina, United States
Carteret Medical Group
Morehead City, North Carolina, United States
West Clinical Research
Morehead City, North Carolina, United States
Velocity Clinical Research - Cincinnati
Blue Ash, Ohio, United States
Velocity Clinical Research - Springdale
Cincinnati, Ohio, United States
Velocity Clinical Research - Providence
East Greenwich, Rhode Island, United States
Medical Care LLC
Elizabethton, Tennessee, United States
Elligo Clinical Research Center
Austin, Texas, United States
Osvaldo A Brusco MD PA
Corpus Christi, Texas, United States
Cedar Health Research, LLC
Dallas, Texas, United States
Soma Clinical Trials, LLC
Denison, Texas, United States
Cedar Health Research, LLC
Euless, Texas, United States
Juno Research LLC
Houston, Texas, United States
Juno Research LLC
Houston, Texas, United States
Tekton Research
McKinney, Texas, United States
Northeast Clinical Research of San Antonio LLC
San Antonio, Texas, United States
Alliance for Multispecialty Research - Layton
Layton, Utah, United States
Manassas Clinical Research Center Inc
Manassas, Virginia, United States
VA Puget Sound Healthcare System
Seattle, Washington, United States
Ima Clinical Research - West Virginia
Morgantown, West Virginia, United States
Centro Medico Viamonte
CABA, Buenos Aires, Argentina
Cedic Centro de Investigacion Clinica
CABA, Buenos Aires, Argentina
Cemedic Centro de Especialidades Medicas
CABA, Buenos Aires, Argentina
Maffei Centro Medico
CABA, Buenos Aires, Argentina
Consultorios Medicos Dr Besada
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
Ambulatory for specialized outpatient medical aid in endocrinology-Dr Albena Dinkova EOOD
Pleven, , Bulgaria
Diagnostic - Consultative Center XX - Sofia EOOD
Sofia, , Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment Sofiamed OOD
Sofia, , Bulgaria
Prevencia-2000-Medical center for outpatient medical aid OOD
Stara Zagora, , Bulgaria
Medical Center Berbatov EOOD
Yambol, , Bulgaria
tlc Diabetes and Endocrinology
Surrey, British Columbia, Canada
Chronic Disease Innovation Centre
Winnipeg, Manitoba, Canada
Nova Scotia Health Authority, Queen Elizabeth ii Health Sciences Centre
Halifax, Nova Scotia, Canada
Centricity Research Brampton
Brampton, Ontario, Canada
Aggarwal and Associates Ltd
Brampton, Ontario, Canada
Centricity Research Vaughan
Concord, Ontario, Canada
Winterberry Family Medicine
Hamilton, Ontario, Canada
Premier Clinical Trial Network
Hamilton, Ontario, Canada
Milestone Research
London, Ontario, Canada
Centricity Research Ottawa LMC
Nepean, Ontario, Canada
Your Research Network Inc.
Niagara Falls, Ontario, Canada
North York Diagnostic and Cardiac Centre
North York, Ontario, Canada
Bluewater Clinical Research Group Incorporated
Sarnia, Ontario, Canada
Albion Finch Medical Centre
Toronto, Ontario, Canada
Centricity Research Quebec City
Lévis, Quebec, Canada
Institut de recherches cliniques de Montreal
Montreal, Quebec, Canada
Centre Medical Acadie
Montreal, Quebec, Canada
Centricity Research Pointe-Claire
Pointe-Claire, Quebec, Canada
Diex Recherche Trois Rivieres
Trois-Rivières, Quebec, Canada
Fakultni nemocnice Brno
Brno, , Czechia
CCR Ostrava sro
Ostrava, , Czechia
Diahelp sro
Pardubice, , Czechia
Pratia Pardubice as
Pardubice, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Institut klinicke a experimentalni mediciny
Prague, , Czechia
Milan Kvapil sro
Prague, , Czechia
Restrial sro
Prague, , Czechia
Endokrinologie Cerny Most sro
Prague, , Czechia
Milan Kvapil sro
Pribram VIII, , Czechia
Universitatsklinikum Aachen
Aachen, , 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
Zentrum fuer Klinische Studien Suedbrandenburg GmbH
Elsterwerda, , Germany
InnoDiab Forschung
Essen, , Germany
Schwerpunktpraxis fuer Diabetes, Gefaess- & Ernaehrungsmedizin
Falkensee, , Germany
Diabeteszentrum Hamburg West
Hamburg, , Germany
Endokrinologikum Hamburg
Hamburg, , Germany
Diabetologische Schwerpunktpraxis Hohenmoelsen
Hohenmölsen, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
AmBeNet GmbH
Leipzig, , 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
Red-Institut GmbH
Oldenburg, , Germany
Lausmed Kft
Baja, , Hungary
DRC Gyogyszervizsgalo Kozpont Kft
Balatonfüred, , Hungary
Clinexpert Kft
Budapest, , Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest, , Hungary
ClinDiab Kft
Budapest, , Hungary
MED-TIMA Kft
Budapest, , Hungary
Borvo Clinic Kft
Debrecen, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Komaromi Selye Janos Korhaz
Komárom, , Hungary
Borbanya Praxis Egeszsegugyi Kft
Nyíregyháza, , Hungary
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
Szombathely, , Hungary
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
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, , Italy
IRCCS Centro Cardiologico Monzino
Milan, , Italy
Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco
Milan, , Italy
Ospedale Civico, Di Cristina e Benfratelli
Palermo, , Italy
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
Matsuyama, Ehime, Japan
Morizono Medical Clinic
Kitakyusyu-shi, Fukuoka, Japan
Mazda Hospital of Mazda Motor Corporation
Aki-gun, Hiroshima, Japan
Nakamoto Medical Clinic
Mito, Ibaraki, Japan
Nakakinen Clinic
Naka, Ibaraki, Japan
Ohishi Naika Clinic
Tsuchiura-shi, Ibaraki, Japan
Morinaga Ueno Clinic
Kumamoto, Kumamoto, Japan
Shiraiwa Medical Clinic
Kashiwara-shi, Osaka, Japan
Suruga Clinic
Shizuoka, Shizuoka, Japan
Yutenji Medical Clinic
Meguro-ku, Tokyo, Japan
Medical Corporation Ouitsukai Kanno Naika
Mitaka-shi, Tokyo, Japan
Salvia-Lekston i Madej Spolka Jawna
Katowice, , Poland
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz, , Poland
Clinical Best Solutions Sp zoo Spolka Komandytowa Gabinet Lekarski
Lublin, , Poland
Ekamed Spolka z Ograniczona Odpowiedzialnoscia
Lublin, , Poland
Medicome Spolka z Ograniczona Odpowiedzialnoscia
Oświęcim, , Poland
Velocity Nova Sp zoo Velocity Pulawy
Puławy, , Poland
NZOZ Przychodnia Specjalistyczna A Wittek H Rudzki spolka jawna
Ruda Śląska, , Poland
Velocity Nova Sp zoo Velocity Staszow
Staszów, , Poland
Tomasz Blicharski Lubelskie Centrum Diagnostyczne
Świdnik, , Poland
Nbr Polska Tomasz Klodawski
Warsaw, , Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
Warsaw, , Poland
Wromedica I Bielicka A Strzalkowska SC
Wroclaw, , Poland
Latin Clinical Trial Center
San Juan, , Puerto Rico
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, , South Korea
Korea University Anam Hospital
Seoul, , 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
Asan Medical Center
Seoul, , South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, , South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, , South Korea
Yonsei University Wonju Severance Christian Hospital
Wonju-si, Gangwon-do, , South Korea
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
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
Clifton Medical Centre
Rotherham, , United Kingdom
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20210184
Identifier Type: -
Identifier Source: org_study_id