A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM)

Last updated: May 14, 2025
Sponsor: Amgen
Overall Status: Active - Not Recruiting

Phase

2

Condition

Diabetes Prevention

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Treatment

Maridebart Cafraglutide

Placebo

Clinical Study ID

NCT06660173
20230143
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years at screening (or ≥ legal age within the country if it is older than 18 years)

  • Type 2 diabetes for ≥6 months according to the World Health Organizationclassification

  • HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory

  • Treatment of diabetes with diet and exercise alone, or with a stable dose ofmetformin, with or without a sodium-glucose cotransporter-2 inhibitor, for at least 3 months prior to screening

  • Body mass index of 23 to 50 kilograms per square meter

Exclusion

Exclusion Criteria:

  • Type 1 diabetes

  • Use of any glucose-lowering medication, other than metformin with or without asodium-glucose cotransporter-2 inhibitor, within 3 months prior to screening

  • Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 squaremeter, calculated by the Chronic Kidney Disease-Epidemiology equation.

  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy

  • History of acute or chronic pancreatitis

  • Malignancy within 5 years before screening, except for nonmelanoma skin cancer, insitu carcinoma of the cervix, or in situ prostate cancer

  • Myocardial infarction, unstable angina, coronary artery bypass graft surgery orother major cardiovascular surgery, percutaneous coronary intervention, transientischemic attack, cerebrovascular accident, or decompensated congestive heart failurewithin 90 days prior to screening, or currently have New York Heart AssociationClass III or IV heart failure.

  • Use of medications that affect glucose control or body weight or history ofbariatric surgery or procedures.

Study Design

Total Participants: 409
Treatment Group(s): 2
Primary Treatment: Maridebart Cafraglutide
Phase: 2
Study Start date:
November 07, 2024
Estimated Completion Date:
June 25, 2026

Connect with a study center

  • Medizinische Universitaet Graz

    Graz, 8036
    Austria

    Site Not Available

  • Krankenhaus der Barmherzigen Brueder Linz

    Linz, 4021
    Austria

    Site Not Available

  • Klinik Hietzing

    Wien, 1130
    Austria

    Site Not Available

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Wien, 1090
    Austria

    Site Not Available

  • Laiko General Hospital of Athens

    Athens, 11527
    Greece

    Site Not Available

  • Athens Medical Center S.A - Iatriko Amarousiou

    Maroussi, 15125
    Greece

    Site Not Available

  • Athens Medical Center- Iatriko Paleou Falirou

    Palaio Faliro, 17562
    Greece

    Site Not Available

  • Geniko Nosokomeio Peiraia Tzaneio

    Piraeus, 18536
    Greece

    Site Not Available

  • General Hospital of Thessaloniki Ahepa

    Thessaloniki, 54636
    Greece

    Site Not Available

  • Thermi Clinic S.A.

    Thessaloniki, 57001
    Greece

    Site Not Available

  • Queen Mary Hospital / HKU

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong,
    Hong Kong

    Site Not Available

  • Lausmed Kft

    Baja, 6500
    Hungary

    Site Not Available

  • Drug Research Center Kft

    Balatonfured, 8230
    Hungary

    Site Not Available

  • Clinexpert Kft

    Budapest, 1033
    Hungary

    Site Not Available

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036
    Hungary

    Site Not Available

  • Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft

    Budapest, 1036
    Hungary

    Site Not Available

  • Szent Margit Rendelointezet Diabetologiai Ambulancia

    Budapest, 1032
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

    Site Not Available

  • CRU Hungary Kft

    Encs, 3860
    Hungary

    Site Not Available

  • Borbanya Praxis Egeszsegugyi Kft

    Nyiregyhaza, 4405
    Hungary

    Site Not Available

  • Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft

    Zalaegerszeg, 8900
    Hungary

    Site Not Available

  • Azienda Universitaria Ospedaliera Consorziale Policlinico Bari

    Bari, 70124
    Italy

    Site Not Available

  • IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola

    Bologna, 40138
    Italy

    Site Not Available

  • Universita degli Studi Gabriele D Annunzio di Chieti e Pescara

    Chieti, 66100
    Italy

    Site Not Available

  • IRCCS Ospedale San Raffaele

    Milan, 20132
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco

    Milano, 20157
    Italy

    Site Not Available

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Site Not Available

  • Kunisaki Makoto Clinic

    Fukuoka-shi, Fukuoka 819-0168
    Japan

    Site Not Available

  • Nakamoto Medical Clinic

    Mito-shi, Ibaraki 310-0826
    Japan

    Site Not Available

  • Ohishi Naika Clinic

    Tsuchiura-shi, Ibaraki 300-0835
    Japan

    Site Not Available

  • Morinaga Ueno Clinic

    Kumamoto-shi, Kumamoto 860-0863
    Japan

    Site Not Available

  • MorinagaUeno Clinic

    Kumamoto-shi, Kumamoto 860-0863
    Japan

    Active - Recruiting

  • Midori Clinic

    Nagasaki-shi, Nagasaki 852-8034
    Japan

    Site Not Available

  • Shiraiwa Medical Clinic

    Kashiwara-shi, Osaka 582-0005
    Japan

    Site Not Available

  • Plumeria DM Clinic

    Shizuoka-shi, Shizuoka 422-8006
    Japan

    Site Not Available

  • Yutenji Medical Clinic

    Meguro-ku, Tokyo 153-0053
    Japan

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Kangbuk Samsung Hospital

    Seoul, 03181
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Nzoz Specjalistyczny Osrodek Internistyczno-Diabetologiczny Malgorzata Arciszewska

    Bialystok, 15-435
    Poland

    Site Not Available

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

    Krakow, 30-688
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny numer 4 Centrum Innowacyjnych Terapii

    Lublin, 20-090
    Poland

    Site Not Available

  • Nowe Zdrowie-Ck Kieltucki i Wspolnicy Spolka Jawna

    Staszow, 28-200
    Poland

    Site Not Available

  • Nbr Polska Tomasz Klodawski

    Warszawa, 00-710
    Poland

    Site Not Available

  • Centrum Badan Klinicznych Piotr Napora lekarze spolka partnerska

    Wroclaw, 51-162
    Poland

    Site Not Available

  • Futuremeds spolka z ograniczona odpowiedzialnoscia

    Wroclaw, 53-673
    Poland

    Site Not Available

  • Latin Clinical Trial Center

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • Mariodiab Clinic SRL

    Brasov, 500101
    Romania

    Site Not Available

  • Centrul pentru Studiul Metabolismului - Hightech Medical Services SRL

    Bucharest, 011052
    Romania

    Site Not Available

  • Institutul National de Diabet si Nutritie si Boli Metabolice N C Paulescu

    Bucuresti, 030167
    Romania

    Site Not Available

  • Consultmed SRL

    Iasi, 700544
    Romania

    Site Not Available

  • Clinica Korall

    Satu Mare, 440055
    Romania

    Site Not Available

  • Hospital Vithas Sevilla

    Castilleja de la Cuesta, Andalucía 41950
    Spain

    Site Not Available

  • Hospital Clinico Universitario Virgen de la Victoria

    Malaga, Andalucía 29010
    Spain

    Site Not Available

  • Hospital Universitario Arnau de Vilanova Lleida

    Lleida, Cataluña 25198
    Spain

    Site Not Available

  • Hospital Universitario de La Ribera

    Alzira, Comunidad Valenciana 46600
    Spain

    Site Not Available

  • Complexo Hospitalario Universitario A Coruña

    A Coruña, Galicia 15006
    Spain

    Site Not Available

  • Ostra Sjukhuset

    Goteborg, 416 85
    Sweden

    Site Not Available

  • Skanes universitetssjukhus

    Lund, 222 42
    Sweden

    Site Not Available

  • Universitetssjukhuset Orebro

    Orebro, 703 62
    Sweden

    Site Not Available

  • Sabbatsbergs Sjukhus

    Stockholm, 113 61
    Sweden

    Site Not Available

  • Sodersjukhuset

    Stockholm, 118 83
    Sweden

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 80756
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 70403
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • Accel Research Site - Birmingham Clinical Research Unit

    Birmingham, Alabama 35216
    United States

    Site Not Available

  • Anaheim Clinical Trials

    Anaheim, California 92801
    United States

    Site Not Available

  • Hope Clinical Research LLC

    Canoga Park, California 91303
    United States

    Site Not Available

  • Orange County Research Center

    Lake Forest, California 92630
    United States

    Site Not Available

  • San Jose Clinical Trials

    San Jose, California 95128
    United States

    Site Not Available

  • Northeast Research Institute - Neri

    Fleming Island, Florida 32003
    United States

    Site Not Available

  • New Horizon Research Center

    Miami, Florida 33165
    United States

    Site Not Available

  • Florida Institute for Clinical Research

    Orlando, Florida 32825
    United States

    Site Not Available

  • Conquest Research - Winter Park

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Accel Research Site - Neurostudies

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Cedar Crosse Research and Health Care

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Tandem Clinical Research - Marrero

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • DM Clinical - Detroit

    Southfield, Michigan 48076
    United States

    Site Not Available

  • Montana Medical Research

    Missoula, Montana 59808
    United States

    Site Not Available

  • Physicians East

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Diabetes and Endocrinology Associates of Stark County Inc

    Canton, Ohio 44718
    United States

    Site Not Available

  • Alliance for Multispecialty Research

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Trial Management Associates - Myrtle Beach

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • FutureSearch Trials of Neurology

    Austin, Texas 78731
    United States

    Site Not Available

  • Velocity Clinical Research - Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • DM Clinical Research - Cyfair Clinical Research Center

    Houston, Texas 77065
    United States

    Site Not Available

  • Southern Endocrinology Associates PA

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Be Well Clinical Studies

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Diabetes and Glandular Disease Clinic

    San Antonio, Texas 78229
    United States

    Site Not Available

  • DM Clinical Research - Martin Diagnostic Clinic

    Tomball, Texas 77375
    United States

    Site Not Available

  • Charlottesville Medical Research Center

    Charlottesville, Virginia 22911
    United States

    Site Not Available

  • Manassas Clinical Research Center Inc

    Manassas, Virginia 20110
    United States

    Site Not Available

  • Eastside Research Associates Health Research

    Redmond, Washington 98052
    United States

    Site Not Available

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