Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

NCT06858878 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 20210184
• Study Type: interventional
• Target: 1,105
• Locations: 13 countries
• Sites: 187

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

Keywords

Type 2 Diabetes Mellitus; T2DM; Obesity; Overweight; Maridebart Cafraglutide; AMG 133; MariTide; Chronic Weight Management

Outcome Measures

Primary Outcomes (1)

• Percent Change from Baseline in Body Weight at Week 72

  Baseline and Week 72

Secondary Outcomes (28)

• Change from Baseline in Waist Circumference at Week 72

  Baseline and Week 72

• Participant achieving ≥ 5% reduction in body weight from baseline at week 72

  Baseline and Week 72

• Participant achieving ≥ 10% reduction in body weight from baseline at week 72

  Baseline and Week 72

• Participant achieving ≥ 15% reduction in body weight from baseline at week 72

  Baseline and Week 72

• Change from Baseline in Systolic Blood Pressure (SBP) at Week 72

  Baseline and Week 72

Study Arms (4)

Maridebart Cafraglutide High Dose

EXPERIMENTAL

Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.

Drug: Maridebart cafraglutide

Maridebart Cafraglutide Medium Dose

EXPERIMENTAL

Participants will receive maridebart cafraglutide medium dose SC for 72 weeks.

Drug: Maridebart cafraglutide

Maridebart Cafraglutide Low Dose

EXPERIMENTAL

Participants will receive maridebart cafraglutide low dose SC for 72 weeks.

Drug: Maridebart cafraglutide

Placebo

PLACEBO COMPARATOR

Participants will receive placebo SC for 72 weeks.

Drug: Placebo

Interventions

Maridebart cafraglutide DRUG

Maridebart cafraglutide will be adminstered SC.

Also known as: AMG 133, MariTide

Maridebart Cafraglutide High Dose; Maridebart Cafraglutide Low Dose; Maridebart Cafraglutide Medium Dose

Placebo DRUG

Placebo will be adminstered SC.

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• 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.

You may not qualify if:

• Type 1 diabetes mellitus.
• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (187)

Alliance for Multispecialty Research Mobile

Mobile, Alabama, 36608, United States

Location

Gilbert Center for Family Medicine

Gilbert, Arizona, 85296, United States

Location

Desert Clinical Research

Mesa, Arizona, 85213, United States

Location

Avacare Foothills Research Center

Phoenix, Arizona, 85044, United States

Location

San Fernando Valley Health Institute

Canoga Park, California, 91304, United States

Location

Core Healthcare Group

Cerritos, California, 90703, United States

Location

Velocity Clinical Research Chula Vista

Chula Vista, California, 91911, United States

Location

Headlands Research California

Escondido, California, 92025, United States

Location

Paradigm Clinical Research

Modesto, California, 95355, United States

Location

Flourish Research

Northridge, California, 91325, United States

Location

University of California Irvine

Orange, California, 92868, United States

Location

Empire Clinical Research

Pomona, California, 91767, United States

Location

Infinity Clinical Trials

San Diego, California, 92108, United States

Location

Greenwich Clinical Trials

Riverside, Connecticut, 06878, United States

Location

Indago Research and Health Center

Hialeah, Florida, 33012, United States

Location

Optimus U Corporation

Miami, Florida, 33135, United States

Location

New Horizon Research Center

Miami, Florida, 33165, United States

Location

San Marcus Research Clinic Inc

Miami Lakes, Florida, 33014, United States

Location

Florida Institute for Clinical Research

Orlando, Florida, 32825, United States

Location

Encore Medical Research of Weston LLC

Weston, Florida, 33331, United States

Location

Conquest Research - Winter Park

Winter Park, Florida, 32789, United States

Location

Alliance For Multispecialty Research - Oak Brook

Oak Brook, Illinois, 60523, United States

Location

Alliance for Multispecialty Research, LLC - Park Ridge

Park Ridge, Illinois, 66068, United States

Location

Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie

Skokie, Illinois, 60077, United States

Location

Indiana Medical Research Institute

Merrillville, Indiana, 46410, United States

Location

Iowa Diabetes Research

West Des Moines, Iowa, 50266, United States

Location

Alliance for Multispecialty Research Newton

Newton, Kansas, 67114, United States

Location

Alliance for Multispecialty Research LLC

Wichita, Kansas, 67207, United States

Location

Advanced Internal Medicine

Paducah, Kentucky, 42001, United States

Location

Ima Clinical Research- Monroe

Monroe, Louisiana, 71201, United States

Location

Annapolis Internal Medicine, LLC

Annapolis, Maryland, 21401, United States

Location

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

International Diabetes Center - HealthPartners Institute

Minneapolis, Minnesota, 55416, United States

Location

Alliance for Multispecialty Research - Kansas City

Kansas City, Missouri, 64114, United States

Location

Palm Research Center Inc

Las Vegas, Nevada, 89128, United States

Location

Vector Clinical Trials

Sparks, Nevada, 89436, United States

Location

Premier Research

Trenton, New Jersey, 08611, United States

Location

Albany Medical College

Albany, New York, 12203, United States

Location

Asheville Clinical Research

Asheville, North Carolina, 28803, United States

Location

Physicians East

Greenville, North Carolina, 27834, United States

Location

Carteret Medical Group

Morehead City, North Carolina, 28557, United States

Location

West Clinical Research

Morehead City, North Carolina, 28557, United States

Location

Velocity Clinical Research - Cincinnati

Blue Ash, Ohio, 45242, United States

Location

Velocity Clinical Research - Springdale

Cincinnati, Ohio, 45246, United States

Location

Velocity Clinical Research - Providence

East Greenwich, Rhode Island, 02818, United States

Location

Medical Care LLC

Elizabethton, Tennessee, 37643, United States

Location

Elligo Clinical Research Center

Austin, Texas, 78701, United States

Location

Osvaldo A Brusco MD PA

Corpus Christi, Texas, 78414, United States

Location

Cedar Health Research, LLC

Dallas, Texas, 75251, United States

Location

Soma Clinical Trials, LLC

Denison, Texas, 75020, United States

Location

Cedar Health Research, LLC

Euless, Texas, 76040, United States

Location

Juno Research LLC

Houston, Texas, 77040, United States

Location

Juno Research LLC

Houston, Texas, 77054, United States

Location

Tekton Research

McKinney, Texas, 75069, United States

Location

Northeast Clinical Research of San Antonio LLC

San Antonio, Texas, 78233, United States

Location

Alliance for Multispecialty Research - Layton

Layton, Utah, 84041, United States

Location

Manassas Clinical Research Center Inc

Manassas, Virginia, 20110, United States

Location

VA Puget Sound Healthcare System

Seattle, Washington, 98108, United States

Location

Ima Clinical Research - West Virginia

Morgantown, West Virginia, 26505, United States

Location

Centro Medico Viamonte

CABA, Buenos Aires, 1120, Argentina

Location

Cedic Centro de Investigacion Clinica

CABA, Buenos Aires, C1060ABN, Argentina

Location

Cemedic Centro de Especialidades Medicas

CABA, Buenos Aires, C1407GTN, Argentina

Location

Maffei Centro Medico

CABA, Buenos Aires, C1425AGC, Argentina

Location

Consultorios Medicos Dr Besada

CABA, Buenos Aires, C1426ABP, Argentina

Location

Cinme - Centro de Investigaciones Metabolicas

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1056ABI, Argentina

Location

Ciprec Centro de Investigacion y Prevencion Cardiovascular

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1061AAT, Argentina

Location

Ambulatory for specialized outpatient medical aid in endocrinology-Dr Albena Dinkova EOOD

Pleven, 5801, Bulgaria

Location

Diagnostic - Consultative Center XX - Sofia EOOD

Sofia, 1404, Bulgaria

Location

Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD

Sofia, 1407, Bulgaria

Location

University Multiprofile Hospital for Active Treatment Sofiamed OOD

Sofia, 1750, Bulgaria

Location

Prevencia-2000-Medical center for outpatient medical aid OOD

Stara Zagora, 6000, Bulgaria

Location

Medical Center Berbatov EOOD

Yambol, 8600, Bulgaria

Location

tlc Diabetes and Endocrinology

Surrey, British Columbia, V3T 2V6, Canada

Location

Chronic Disease Innovation Centre

Winnipeg, Manitoba, R2V 3M3, Canada

Location

Nova Scotia Health Authority, Queen Elizabeth ii Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Centricity Research Brampton

Brampton, Ontario, L6S 0C6, Canada

Location

Aggarwal and Associates Ltd

Brampton, Ontario, L6T 0G1, Canada

Location

Centricity Research Vaughan

Concord, Ontario, L4K 4M2, Canada

Location

Winterberry Family Medicine

Hamilton, Ontario, L8J 0B6, Canada

Location

Premier Clinical Trial Network

Hamilton, Ontario, L8L 5G4, Canada

Location

Milestone Research

London, Ontario, N5W 6A2, Canada

Location

Centricity Research Ottawa LMC

Nepean, Ontario, K2J 0V2, Canada

Location

Your Research Network Inc.

Niagara Falls, Ontario, L2H 1H5, Canada

Location

North York Diagnostic and Cardiac Centre

North York, Ontario, M6B 3H7, Canada

Location

Bluewater Clinical Research Group Incorporated

Sarnia, Ontario, N7T 4X3, Canada

Location

Albion Finch Medical Centre

Toronto, Ontario, M9V 4B4, Canada

Location

Centricity Research Quebec City

Lévis, Quebec, G6W 0M5, Canada

Location

Institut de recherches cliniques de Montreal

Montreal, Quebec, H2W 1R7, Canada

Location

Centre Medical Acadie

Montreal, Quebec, H4N 2W2, Canada

Location

Centricity Research Pointe-Claire

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Diex Recherche Trois Rivieres

Trois-Rivières, Quebec, G9A 4P3, Canada

Location

Fakultni nemocnice Brno

Brno, 625 00, Czechia

Location

CCR Ostrava sro

Ostrava, 702 00, Czechia

Location

Diahelp sro

Pardubice, 530 02, Czechia

Location

Pratia Pardubice as

Pardubice, 530 02, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

Location

Institut klinicke a experimentalni mediciny

Prague, 140 21, Czechia

Location

Milan Kvapil sro

Prague, 149 00, Czechia

Location

Restrial sro

Prague, 181 00, Czechia

Location

Endokrinologie Cerny Most sro

Prague, 198 00, Czechia

Location

Milan Kvapil sro

Pribram VIII, 261 01, Czechia

Location

Universitatsklinikum Aachen

Aachen, 52074, Germany

Location

Universitaets-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Diabetespraxis Bad Mergentheim

Bad Mergentheim, 97980, Germany

Location

Universitaetsklinikum der Ruhr-Universitaet Bochum

Bad Oeynhausen, 32545, Germany

Location

Charite - Universitaetsmedizin Berlin, Campus Mitte

Berlin, 10117, Germany

Location

Velocity Clinical Research GmbH

Berlin, 10787, Germany

Location

Diabetespraxis Dr. Hermann Braun

Berlin, 13187, Germany

Location

Mvz am Bahnhof Spandau

Berlin, 13597, Germany

Location

Zentrum fuer Klinische Studien Suedbrandenburg GmbH

Elsterwerda, 04910, Germany

Location

InnoDiab Forschung

Essen, 45136, Germany

Location

Schwerpunktpraxis fuer Diabetes, Gefaess- & Ernaehrungsmedizin

Falkensee, 14612, Germany

Location

Diabeteszentrum Hamburg West

Hamburg, 22607, Germany

Location

Endokrinologikum Hamburg

Hamburg, 22767, Germany

Location

Diabetologische Schwerpunktpraxis Hohenmoelsen

Hohenmölsen, 06679, Germany

Location

Universitaetsklinikum Leipzig

Leipzig, 04103, Germany

Location

AmBeNet GmbH

Leipzig, 04107, Germany

Location

Kardiologische Praxis Doktor Jens Taggeselle

Markkleeberg, 04416, Germany

Location

Centrum für Diagnostik und Gesundheit

München, 80809, Germany

Location

Zentrum fuer Diabtes und Gefaesskrankheiten im Franziskus Carré Muenster

Münster, 48145, Germany

Location

Red-Institut GmbH

Oldenburg, 23758, Germany

Location

Lausmed Kft

Baja, 6500, Hungary

Location

DRC Gyogyszervizsgalo Kozpont Kft

Balatonfüred, 8230, Hungary

Location

Clinexpert Kft

Budapest, 1033, Hungary

Location

Obudai Egeszsegugyi Centrum Kft

Budapest, 1036, Hungary

Location

ClinDiab Kft

Budapest, 1089, Hungary

Location

MED-TIMA Kft

Budapest, 1132, Hungary

Location

Borvo Clinic Kft

Debrecen, 4025, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

Komaromi Selye Janos Korhaz

Komárom, 2900, Hungary

Location

Borbanya Praxis Egeszsegugyi Kft

Nyíregyháza, 4405, Hungary

Location

Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz

Szombathely, 9700, Hungary

Location

IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola

Bologna, 40138, Italy

Location

Universita degli Studi Gabriele D Annunzio di Chieti e Pescara

Chieti, 66100, Italy

Location

Azienda Ospedaliero Universitaria Careggi

Florence, 50134, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

IRCCS Centro Cardiologico Monzino

Milan, 20138, Italy

Location

Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco

Milan, 20157, Italy

Location

Ospedale Civico, Di Cristina e Benfratelli

Palermo, 90127, Italy

Location

Mikannohana Clinic, Diabetes, Endocrinology and Metabolism

Matsuyama, Ehime, 790-0034, Japan

Location

Morizono Medical Clinic

Kitakyusyu-shi, Fukuoka, 807-0072, Japan

Location

Mazda Hospital of Mazda Motor Corporation

Aki-gun, Hiroshima, 735-8585, Japan

Location

Nakamoto Medical Clinic

Mito, Ibaraki, 310-0826, Japan

Location

Nakakinen Clinic

Naka, Ibaraki, 311-0113, Japan

Location

Ohishi Naika Clinic

Tsuchiura-shi, Ibaraki, 300-0835, Japan

Location

Morinaga Ueno Clinic

Kumamoto, Kumamoto, 860-0863, Japan

Location

Shiraiwa Medical Clinic

Kashiwara-shi, Osaka, 582-0005, Japan

Location

Suruga Clinic

Shizuoka, Shizuoka, 424-0855, Japan

Location

Yutenji Medical Clinic

Meguro-ku, Tokyo, 153-0053, Japan

Location

Medical Corporation Ouitsukai Kanno Naika

Mitaka-shi, Tokyo, 181-0013, Japan

Location

Salvia-Lekston i Madej Spolka Jawna

Katowice, 40-772, Poland

Location

Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

Lodz, 90-338, Poland

Location

Clinical Best Solutions Sp zoo Spolka Komandytowa Gabinet Lekarski

Lublin, 20-011, Poland

Location

Ekamed Spolka z Ograniczona Odpowiedzialnoscia

Lublin, 20-718, Poland

Location

Medicome Spolka z Ograniczona Odpowiedzialnoscia

Oświęcim, 32-600, Poland

Location

Velocity Nova Sp zoo Velocity Pulawy

Puławy, 24-100, Poland

Location

NZOZ Przychodnia Specjalistyczna A Wittek H Rudzki spolka jawna

Ruda Śląska, 41-709, Poland

Location

Velocity Nova Sp zoo Velocity Staszow

Staszów, 28-200, Poland

Location

Tomasz Blicharski Lubelskie Centrum Diagnostyczne

Świdnik, 21-040, Poland

Location

Nbr Polska Tomasz Klodawski

Warsaw, 00-710, Poland

Location

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji

Warsaw, 02-507, Poland

Location

Wromedica I Bielicka A Strzalkowska SC

Wroclaw, 51-685, Poland

Location

Latin Clinical Trial Center

San Juan, 00909, Puerto Rico

Location

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, 15355, South Korea

Location

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

KyungHee University Gangdong Hospital

Seoul, 05278, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07441, South Korea

Location

Yonsei University Wonju Severance Christian Hospital

Wonju-si, Gangwon-do, 26426, South Korea

Location

Ormeau Clinical Trials Ltd

Belfast, BT28BG, United Kingdom

Location

FutureMeds Birmingham

Birmingham, B21 9RY, United Kingdom

Location

Layton Medical Centre

Blackpool, FY3 7EN, United Kingdom

Location

Waterloo Medical Centre

Blackpool, FY4 3AD, United Kingdom

Location

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

Staploe Medical Centre

Ely, CB7 5JD, United Kingdom

Location

FutureMeds Glasgow

Glasgow, G20 7BE, United Kingdom

Location

Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

Location

NIHR Leicestershire & Northamptonshire Commercial Research Delivery Centre

Leicester, LE5 4PW, United Kingdom

Location

Aintree University Hospital

Liverpool, L9 7AL, United Kingdom

Location

Clifton Medical Centre

Rotherham, S65 1DA, United Kingdom

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Overweight

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 5, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): January 21, 2027
• Study Completion (Estimated): April 16, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

BU (6); GB (11); US (59); CA (19); JP (11); CZ (11); IT (7); DE (20); HU (11); PL (12); PR (1); AR (7); KR (12)