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

Last updated: July 24, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Prevention

Diabetes And Hypertension

Obesity

Treatment

Maridebart Cafraglutide

Placebo

Clinical Study ID

NCT06858839
20210181
2024-515524-36
  • Ages 18-99
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years.

  • Body mass index ≥ 30 kg/m2 or ≥27 kg/m² to < 30 kg/m2 with at least 1 of thefollowing weight-related comorbidities: hypertension, dyslipidemia, history ofobstructive sleep apnea, history of cardiovascular disease, history of metabolicdysfunction-associated steatotic liver disease (MASLD) or MetabolicDysfunction-Associated Steatohepatitis (MASH).

  • History of at least 1 self-reported unsuccessful attempt at weight loss by diet andexercise.

Exclusion

Exclusion Criteria:

  • Type 1 or Typ2 diabetes mellitus.

  • 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 daysbefore screening.

  • History of unstable major depressive disorder (MDD) or other severe psychiatricdisorder within 2 years before screening.

  • Lifetime history of suicide attempt.

Study Design

Total Participants: 3501
Treatment Group(s): 2
Primary Treatment: Maridebart Cafraglutide
Phase: 3
Study Start date:
March 12, 2025
Estimated Completion Date:
April 16, 2027

Connect with a study center

  • Cedic - Centro de Investigacion Clinica

    Caba, Buenos Aires 1060
    Argentina

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  • Cemedic Centro de Especialidades Medicas

    Caba, Buenos Aires C1407GTN
    Argentina

    Active - Recruiting

  • Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

    Caba, Buenos Aires C1425AGC
    Argentina

    Active - Recruiting

  • Centro Medico Viamonte

    Caba, Buenos Aires 1120
    Argentina

    Active - Recruiting

  • Consultorios Medicos Dr Besada

    Caba, Buenos Aires C1426ABP
    Argentina

    Active - Recruiting

  • Fundacion Respirar

    Caba, Buenos Aires C1426ABP
    Argentina

    Active - Recruiting

  • Cinme - Centro de Investigaciones Metabolicas

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1056ABI
    Argentina

    Active - Recruiting

  • Ciprec - Centro de Investigacion y Prevencion Cardiovascular

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1061AAT
    Argentina

    Active - Recruiting

  • Emeritus Research Sydney

    Botany, New South Wales 2019
    Australia

    Active - Recruiting

  • Novatrials

    Kotara, New South Wales 2289
    Australia

    Active - Recruiting

  • Canopy Clinical Sutherland

    Miranda, New South Wales 2228
    Australia

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  • Sutherland Shire Clinical Research

    Miranda, New South Wales 2228
    Australia

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  • Royal North Shore Hospital

    St Leonards, New South Wales 2065
    Australia

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  • Canopy Clinical Wollongong

    Wollongong, New South Wales 2500
    Australia

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  • Wollongong Clinical Research

    Wollongong, New South Wales 2500
    Australia

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  • Logan Hospital

    Meadowbrook, Queensland 4131
    Australia

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  • Fusion Clinical Research

    Norwood, South Australia 5067
    Australia

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  • Southern Adelaide Diabetes and Endocrine Services

    Oaklands Park, South Australia 5046
    Australia

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  • Altona Clinical Research

    Altona North, Victoria 3025
    Australia

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  • Canopy Clinical Altona North

    Altona North, Victoria 3025
    Australia

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    Camberwell, Victoria 3124
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    Heidelberg West, Victoria 3081
    Australia

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    Boussu, 7300
    Belgium

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    Edegem, 2650
    Belgium

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  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

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  • Algemeen Ziekenhuis Groeninge - Campus Kennedylaan

    Kortrijk, 8500
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    Leuven, 3000
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    Czechia

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    Czechia

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    Falkensee, 14612
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  • ClinPhenomics CVC GmbH

    Frankfurt am Main, 60596
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  • Diabeteszentrum Hamburg West

    Hamburg, 22607
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  • Braun Ambulantes Herzzentrum Kassel

    Kassel, 34121
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    Leipzig, 04107
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  • Universitaetsklinikum Leipzig

    Leipzig, 04103
    Germany

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  • Universitaetsklinikum Schleswig-Holstein - Luebeck

    Luebeck, 23538
    Germany

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  • Marienhaus Klinikum Mainz

    Mainz, 55131
    Germany

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  • Kardiologische Praxis Doktor Jens Taggeselle

    Markkleeberg, 04416
    Germany

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  • Centrum für Diagnostik und Gesundheit

    Muenchen, 80809
    Germany

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  • Zentrum fuer Diabtes und Gefaesskrankheiten im Franziskus Carré Muenster

    Muenster, 48145
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  • Praxis Segner - Dr. Braun - Kirsch

    Oberwuerzbach, 66386
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    Oldenburg, 23758
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  • Gemeinschaftspraxis Prof Jacob/ Dr Jacob

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  • Zentrum fuer klinische Forschung Allgaeu Oberschwaben

    Wangen IM Allgaeu, 88239
    Germany

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  • IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola

    Bologna, 40138
    Italy

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    Chieti, 66100
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    Firenze, 50134
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    Milano, 20157
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    Milano, 20138
    Italy

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    Pisa, 56126
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  • Fondazione Policlinico Tor Vergata

    Roma, 00133
    Italy

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  • Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic

    Yokohama-shi, Kanagawa 231-0023
    Japan

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  • Doujin Memorial Foundation, Meiwa Hospital

    Chiyoda-ku, Tokyo 101-0041
    Japan

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  • Tokyo Asbo Clinic

    Chuo-ku, Tokyo 104-0031
    Japan

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  • Medical Corp Seikoukai New Medical Research System Clinic

    Hachioji-shi, Tokyo 192-0046
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  • Medical Corporation AOT Shinagawa Strings Clinic

    Minato-ku, Tokyo 108-0075
    Japan

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  • Clinical Research Hospital Tokyo

    Shinjuku-ku, Tokyo 160-0004
    Japan

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  • Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic

    Suginami-ku, Tokyo 166-0003
    Japan

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  • Korea University Ansan Hospital

    Ansan-si, Gyeonggi-do, 15355
    Korea, Republic of

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  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do, 14068
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  • The Catholic University of Korea Bucheon St Marys Hospital

    Bucheon, Gyeonggi-do, 14647
    Korea, Republic of

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  • Dong-A University Hospital

    Busan, 49201
    Korea, Republic of

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  • Daejeon Eulji Medical Center, Eulji University

    DaeJeon, 35233
    Korea, Republic of

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  • Kyungpook National University Hospital

    Daegu, 41944
    Korea, Republic of

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  • Yeungnam University Medical Center

    Daegu, 42415
    Korea, Republic of

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  • Konyang University Hospital

    Daejeon, 35365
    Korea, Republic of

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  • Dongguk University Ilsan Hospital

    Goyang-si, Gyeonggi-do, 10326
    Korea, Republic of

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  • Gachon University Gil Medical Center

    Incheon, 21565
    Korea, Republic of

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  • Seoul National University Bundang Hospital

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

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  • Kangbuk Samsung Hospital

    Seoul, 03181
    Korea, Republic of

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  • KyungHee University Gangdong Hospital

    Seoul, 05278
    Korea, Republic of

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  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul, 07061
    Korea, Republic of

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  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

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  • Severance Hospital Yonsei University Health System

    Seoul, 03722
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  • The Catholic University of Korea Yeouido St Marys Hospital

    Seoul, 07345
    Korea, Republic of

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  • Ajou University Hospital

    Suwon-si Gyeonggi-do, 16499
    Korea, Republic of

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  • Pusan National University Yangsan Hospital

    Yangsan-si, Gyeongsangnam-do, 50612
    Korea, Republic of

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

    Bialystok, 15-281
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    Bialystok, 15-481
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    Debica, 39-200
    Poland

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    Gdynia, 81-384
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    Katowice, 40-772
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    Katowice, 40-752
    Poland

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    Lodz, 90-338
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    Lublin, 20-718
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    Poznan, 60-589
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    Ponce, 00716
    Puerto Rico

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    Ponce, 00717
    Puerto Rico

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    San Juan, 00909
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    Almeria, Andalucía 04009
    Spain

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    Castilleja de la Cuesta, Andalucía 41950
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    Huelva, Andalucía 21007
    Spain

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    Sanlucar de Barrameda, Andalucía 11540
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    Sevilla, Andalucía 41010
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    Sevilla, Andalucía 41003
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    A Coruña, Galicia 15006
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    Hialeah, Florida 33012
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    Margate, Florida 33063
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    Miami, Florida 33135
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    Miami, Florida 33173
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    Ocala, Florida 34470
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    Orlando, Florida 32801
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    Orlando, Florida 32825
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    Active - Recruiting

  • Headlands Research - Detroit

    Southfield, Michigan 48034
    United States

    Active - Recruiting

  • Prime Health and Wellness Sky Clinical Research Network Group

    Fayette, Mississippi 39069
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research - Kansas City

    Kansas City, Missouri 64114
    United States

    Active - Recruiting

  • Palm Research Center Inc

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

  • Vector Clinical Trials

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

  • Rochester Clinical Research

    Rochester, New York 14609
    United States

    Active - Recruiting

  • Velocity Clinical Research - Vestal

    Vestal, New York 13850
    United States

    Active - Recruiting

  • Accellacare of Hickory

    Hickory, North Carolina 28601
    United States

    Active - Recruiting

  • Carolina Research Center Inc

    Shelby, North Carolina 28150
    United States

    Active - Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Clinical Trial Investigator Clinical Research Center

    Cincinnati, Ohio 45212
    United States

    Active - Recruiting

  • Velocity Clinical Research - Cincinnati

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research - Norman

    Norman, Oklahoma 73069
    United States

    Active - Recruiting

  • Capital Area Research LLC

    Newport, Pennsylvania 17074
    United States

    Active - Recruiting

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island 02818
    United States

    Active - Recruiting

  • Tribe Clinical Research LLC Dba Mountain View Clinical Research

    Greenville, South Carolina 29607
    United States

    Active - Recruiting

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

    Knoxville, Tennessee 37938
    United States

    Active - Recruiting

  • New Phase Research and Development

    Knoxville, Tennessee 37909
    United States

    Active - Recruiting

  • Elligo Clinical Research Center

    Austin, Texas 78704
    United States

    Active - Recruiting

  • Cedar Health Research

    Dallas, Texas 75251
    United States

    Active - Recruiting

  • Cedar Health Research, LLC

    Dallas, Texas 75251
    United States

    Active - Recruiting

  • Epic Medical Research - Texas

    DeSoto, Texas 75115
    United States

    Active - Recruiting

  • Great Lakes Research Institute El Paso Research

    El Paso, Texas 79936
    United States

    Active - Recruiting

  • Cedar Health Research, LLC

    Euless, Texas 76040
    United States

    Active - Recruiting

  • Biopharma Informatic, LLC

    Houston, Texas 77043
    United States

    Active - Recruiting

  • Juno Research LLC

    Houston, Texas 77040
    United States

    Active - Recruiting

  • Southern Endocrinology Associates PA

    Mesquite, Texas 75149
    United States

    Active - Recruiting

  • Great Lakes Research Institute - McAllen Research

    Pharr, Texas 78557
    United States

    Active - Recruiting

  • Clinical Trials of Texas

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Sugar Lakes Family Practice

    Sugar Land, Texas 77479
    United States

    Active - Recruiting

  • Pantheon Clinical Research

    Bountiful, Utah 84010
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research Layton Research Center

    Layton, Utah 84041
    United States

    Active - Recruiting

  • Chrysalis Clinical Research, LLC

    Saint George, Utah 84770
    United States

    Active - Recruiting

  • Washington Center for Weight Management and Research, Inc

    Arlington, Virginia 22206
    United States

    Active - Recruiting

  • Health Research of Hampton Roads

    Newport News, Virginia 23606
    United States

    Active - Recruiting

  • Selma Medical Associates

    Winchester, Virginia 22601
    United States

    Active - Recruiting

  • Allegiance Research Specialists

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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