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

Last updated: September 3, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes And Hypertension

Obesity

Diabetes Mellitus, Type 2

Treatment

Maridebart cafraglutide

Placebo

Clinical Study ID

NCT06858878
20210184
  • 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 ≥ 27 kg/m^2.

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

  • Diagnosis of T2DM.

Exclusion

Exclusion Criteria:

  • 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-proliferativediabetic 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 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: 999
Treatment Group(s): 2
Primary Treatment: Maridebart cafraglutide
Phase: 3
Study Start date:
March 17, 2025
Estimated Completion Date:
April 16, 2027

Connect with a study center

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  • Centro Medico Viamonte

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  • Consultorios Medicos Dr Besada

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  • Maffei Centro Medico

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    CABA, Buenos Aires 3435907 1120
    Argentina

    Active - Recruiting

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    CABA, Buenos Aires 3435907 C1426ABP
    Argentina

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  • Maffei Centro Medico

    CABA, Buenos Aires 3435907 C1425AGC
    Argentina

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  • Cinme - Centro de Investigaciones Metabolicas

    Ciudad Autonoma de Buenos Aires, Buenos Aires 3435907 C1056ABI
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  • Ciprec Centro de Investigacion y Prevencion Cardiovascular

    Ciudad Autonoma de Buenos Aires, Buenos Aires 3435907 C1061AAT
    Argentina

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    Pleven 728203, 5801
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    Sofia, 1407
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    Sofia, 1404
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    Oswiecim, 32-600
    Poland

    Site Not Available

  • Medicome Spolka z Ograniczona Odpowiedzialnoscia

    Oświęcim 3089658, 32-600
    Poland

    Active - Recruiting

  • Velocity Nova Sp zoo Velocity Pulawy

    Pulawy, 24-100
    Poland

    Site Not Available

  • Velocity Nova Sp zoo Velocity Pulawy

    Puławy 760924, 24-100
    Poland

    Active - Recruiting

  • NZOZ Przychodnia Specjalistyczna A Wittek H Rudzki spolka jawna

    Ruda Slaska, 41-709
    Poland

    Site Not Available

  • NZOZ Przychodnia Specjalistyczna A Wittek H Rudzki spolka jawna

    Ruda Śląska 3086800, 41-709
    Poland

    Active - Recruiting

  • Velocity Nova Sp zoo Velocity Staszow

    Staszow, 28-200
    Poland

    Site Not Available

  • Velocity Nova Sp zoo Velocity Staszow

    Staszów 758252, 28-200
    Poland

    Active - Recruiting

  • Tomasz Blicharski Lubelskie Centrum Diagnostyczne

    Swidnik, 21-040
    Poland

    Site Not Available

  • Nbr Polska Tomasz Klodawski

    Warsaw 756135, 00-710
    Poland

    Active - Recruiting

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji

    Warsaw 756135, 02-507
    Poland

    Active - Recruiting

  • Nbr Polska Tomasz Klodawski

    Warszawa, 00-710
    Poland

    Active - Recruiting

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji

    Warszawa, 02-507
    Poland

    Site Not Available

  • Wromedica I Bielicka A Strzalkowska SC

    Wroclaw, 51-685
    Poland

    Site Not Available

  • Wromedica I Bielicka A Strzalkowska SC

    Wroclaw 3081368, 51-685
    Poland

    Active - Recruiting

  • Tomasz Blicharski Lubelskie Centrum Diagnostyczne

    Świdnik 757692, 21-040
    Poland

    Active - Recruiting

  • Latin Clinical Trial Center

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • Latin Clinical Trial Center

    San Juan 4568127, 00909
    Puerto Rico

    Active - Recruiting

  • Korea University Ansan Hospital

    Ansan-si, Gyeonggi-do, 15355
    South Korea

    Active - Recruiting

  • Yeungnam University Medical Center

    Daegu 1835329, 42415
    South Korea

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620
    South Korea

    Active - Recruiting

  • Asan Medical Center

    Seoul 1835848, 05505
    South Korea

    Active - Recruiting

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul 1835848, 07441
    South Korea

    Active - Recruiting

  • Kangbuk Samsung Hospital

    Seoul 1835848, 03181
    South Korea

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul 1835848, 02841
    South Korea

    Active - Recruiting

  • KyungHee University Gangdong Hospital

    Seoul 1835848, 05278
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul 1835848, 03722
    South Korea

    Active - Recruiting

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul 1835848, 06591
    South Korea

    Active - Recruiting

  • Yonsei University Wonju Severance Christian Hospital

    Wonju-si, Gangwon-do 1833105, 26426
    South Korea

    Active - Recruiting

  • Ormeau Clinical Trials Ltd

    Belfast, BT28BG
    United Kingdom

    Site Not Available

  • Ormeau Clinical Trials Ltd

    Belfast 2655984, BT28BG
    United Kingdom

    Active - Recruiting

  • FutureMeds Birmingham

    Birmingham, B21 9RY
    United Kingdom

    Site Not Available

  • FutureMeds Birmingham

    Birmingham 2655603, B21 9RY
    United Kingdom

    Active - Recruiting

  • Layton Medical Centre

    Blackpool, FY3 7EN
    United Kingdom

    Active - Recruiting

  • Waterloo Medical Centre

    Blackpool, FY4 3AD
    United Kingdom

    Site Not Available

  • Layton Medical Centre

    Blackpool 2655459, FY3 7EN
    United Kingdom

    Active - Recruiting

  • Waterloo Medical Centre

    Blackpool 2655459, FY4 3AD
    United Kingdom

    Active - Recruiting

  • Southmead Hospital

    Bristol, BS10 5NB
    United Kingdom

    Site Not Available

  • Southmead Hospital

    Bristol 2654675, BS10 5NB
    United Kingdom

    Active - Recruiting

  • Staploe Medical Centre

    Ely, CB7 5JD
    United Kingdom

    Site Not Available

  • Staploe Medical Centre

    Ely 2650023, CB7 5JD
    United Kingdom

    Active - Recruiting

  • FutureMeds Glasgow

    Glasgow, G20 7BE
    United Kingdom

    Site Not Available

  • FutureMeds Glasgow

    Glasgow 2648579, G20 7BE
    United Kingdom

    Active - Recruiting

  • Hull Royal Infirmary

    Hull, HU3 2JZ
    United Kingdom

    Site Not Available

  • Hull Royal Infirmary

    Hull 2645425, HU3 2JZ
    United Kingdom

    Active - Recruiting

  • NIHR Leicestershire & Northamptonshire Commercial Research Delivery Centre

    Leicester, LE5 4PW
    United Kingdom

    Site Not Available

  • NIHR Leicestershire & Northamptonshire Commercial Research Delivery Centre

    Leicester 2644668, LE5 4PW
    United Kingdom

    Active - Recruiting

  • Aintree University Hospital

    Liverpool, L9 7AL
    United Kingdom

    Site Not Available

  • Aintree University Hospital

    Liverpool 2644210, L9 7AL
    United Kingdom

    Active - Recruiting

  • Clifton Medical Centre

    Rotherham, S65 1DA
    United Kingdom

    Site Not Available

  • Clifton Medical Centre

    Rotherham 2639093, S65 1DA
    United Kingdom

    Active - Recruiting

  • Alliance for Multispecialty Research Mobile

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Alliance for Multispecialty Research Mobile

    Mobile 4076598, Alabama 4829764 36608
    United States

    Active - Recruiting

  • Gilbert Center for Family Medicine

    Gilbert, Arizona 85296
    United States

    Site Not Available

  • Desert Clinical Research

    Mesa, Arizona 85213
    United States

    Site Not Available

  • Avacare Foothills Research Center

    Phoenix, Arizona 85044
    United States

    Site Not Available

  • Gilbert Center for Family Medicine

    Gilbert 5295903, Arizona 5551752 85296
    United States

    Active - Recruiting

  • Desert Clinical Research

    Mesa 5304391, Arizona 5551752 85213
    United States

    Active - Recruiting

  • Avacare Foothills Research Center

    Phoenix 5308655, Arizona 5551752 85044
    United States

    Active - Recruiting

  • San Fernando Valley Health Institute

    Canoga Park, California 91304
    United States

    Site Not Available

  • Core Healthcare Group

    Cerritos, California 90703
    United States

    Site Not Available

  • Velocity Clinical Research Chula Vista

    Chula Vista, California 91911
    United States

    Site Not Available

  • Headlands Research California

    Escondido, California 92025
    United States

    Site Not Available

  • Paradigm Clinical Research

    Modesto, California 95355
    United States

    Site Not Available

  • Flourish Research

    Northridge, California 91325
    United States

    Site Not Available

  • University of California Irvine

    Orange, California 92868
    United States

    Site Not Available

  • Empire Clinical Research

    Pomona, California 91767
    United States

    Site Not Available

  • Infinity Clinical Trials

    San Diego, California 92108
    United States

    Site Not Available

  • San Fernando Valley Health Institute

    Canoga Park 5333913, California 5332921 91304
    United States

    Active - Recruiting

  • Core Healthcare Group

    Cerritos 5335663, California 5332921 90703
    United States

    Active - Recruiting

  • Velocity Clinical Research Chula Vista

    Chula Vista 5336899, California 5332921 91911
    United States

    Active - Recruiting

  • Headlands Research California

    Escondido 5346827, California 5332921 92025
    United States

    Active - Recruiting

  • Paradigm Clinical Research

    Modesto 5373900, California 5332921 95355
    United States

    Active - Recruiting

  • Flourish Research

    Northridge 5377985, California 5332921 91325
    United States

    Active - Recruiting

  • University of California Irvine

    Orange 5379513, California 5332921 92868
    United States

    Active - Recruiting

  • Empire Clinical Research

    Pomona 5384170, California 5332921 91767
    United States

    Active - Recruiting

  • Infinity Clinical Trials

    San Diego 5391811, California 5332921 92108
    United States

    Active - Recruiting

  • Greenwich Clinical Trials

    Riverside, Connecticut 06878
    United States

    Site Not Available

  • Greenwich Clinical Trials

    Riverside 4841527, Connecticut 4831725 06878
    United States

    Active - Recruiting

  • Indago Research and Health Center

    Hialeah, Florida 33012
    United States

    Site Not Available

  • New Horizon Research Center

    Miami, Florida 33165
    United States

    Site Not Available

  • Optimus U Corporation

    Miami, Florida 33135
    United States

    Active - Recruiting

  • San Marcus Research Clinic Inc

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Florida Institute for Clinical Research

    Orlando, Florida 32825
    United States

    Site Not Available

  • Encore Medical Research of Weston LLC

    Weston, Florida 33331
    United States

    Site Not Available

  • Conquest Research - Winter Park

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Indago Research and Health Center

    Hialeah 4158476, Florida 4155751 33012
    United States

    Active - Recruiting

  • New Horizon Research Center

    Miami 4164138, Florida 4155751 33165
    United States

    Active - Recruiting

  • Optimus U Corporation

    Miami 4164138, Florida 4155751 33135
    United States

    Active - Recruiting

  • San Marcus Research Clinic Inc

    Miami Lakes 4164186, Florida 4155751 33014
    United States

    Active - Recruiting

  • Florida Institute for Clinical Research

    Orlando 4167147, Florida 4155751 32825
    United States

    Active - Recruiting

  • Encore Medical Research of Weston LLC

    Weston 4178003, Florida 4155751 33331
    United States

    Active - Recruiting

  • Conquest Research - Winter Park

    Winter Park 4178560, Florida 4155751 32789
    United States

    Active - Recruiting

  • Alliance For Multispecialty Research - Oak Brook

    Oak Brook, Illinois 60523
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC - Park Ridge

    Park Ridge, Illinois 66068
    United States

    Site Not Available

  • Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Alliance For Multispecialty Research - Oak Brook

    Oak Brook 4904277, Illinois 4896861 60523
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC - Park Ridge

    Park Ridge 4905367, Illinois 4896861 66068
    United States

    Active - Recruiting

  • Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie

    Skokie 4911600, Illinois 4896861 60077
    United States

    Active - Recruiting

  • Indiana Medical Research Institute

    Merrillville, Indiana 46410
    United States

    Site Not Available

  • Indiana Medical Research Institute

    Merrillville 4923482, Indiana 4921868 46410
    United States

    Active - Recruiting

  • Iowa Diabetes Research

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Iowa Diabetes Research

    West Des Moines 4881346, Iowa 4862182 50266
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research Newton

    Newton, Kansas 67114
    United States

    Site Not Available

  • Alliance for Multispecialty Research LLC

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Alliance for Multispecialty Research Newton

    Newton 4276248, Kansas 4273857 67114
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research LLC

    Wichita 4281730, Kansas 4273857 67207
    United States

    Active - Recruiting

  • Advanced Internal Medicine

    Paducah, Kentucky 42001
    United States

    Site Not Available

  • Advanced Internal Medicine

    Paducah 4048662, Kentucky 6254925 42001
    United States

    Active - Recruiting

  • Ima Clinical Research- Monroe

    Monroe, Louisiana 71201
    United States

    Site Not Available

  • Ima Clinical Research- Monroe

    Monroe 4333669, Louisiana 4331987 71201
    United States

    Active - Recruiting

  • Annapolis Internal Medicine, LLC

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Annapolis Internal Medicine, LLC

    Annapolis 4347242, Maryland 4361885 21401
    United States

    Active - Recruiting

  • Brigham and Womens Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Brigham and Womens Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Active - Recruiting

  • International Diabetes Center - HealthPartners Institute

    Minneapolis, Minnesota 55416
    United States

    Site Not Available

  • International Diabetes Center - HealthPartners Institute

    Minneapolis 5037649, Minnesota 5037779 55416
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research - Kansas City

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Alliance for Multispecialty Research - Kansas City

    Kansas City 4393217, Missouri 4398678 64114
    United States

    Active - Recruiting

  • Palm Research Center Inc

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Vector Clinical Trials

    Sparks, Nevada 89436
    United States

    Site Not Available

  • Palm Research Center Inc

    Las Vegas 5506956, Nevada 5509151 89128
    United States

    Active - Recruiting

  • Vector Clinical Trials

    Sparks 5512862, Nevada 5509151 89436
    United States

    Active - Recruiting

  • Premier Research

    Trenton, New Jersey 08611
    United States

    Site Not Available

  • Premier Research

    Trenton 5105496, New Jersey 5101760 08611
    United States

    Active - Recruiting

  • Albany Medical College

    Albany, New York 12203
    United States

    Site Not Available

  • Albany Medical College

    Albany 5106834, New York 5128638 12203
    United States

    Terminated

  • Asheville Clinical Research

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Physicians East

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Carteret Medical Group

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • West Clinical Research

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • Asheville Clinical Research

    Asheville 4453066, North Carolina 4482348 28803
    United States

    Active - Recruiting

  • Physicians East

    Greenville 4469160, North Carolina 4482348 27834
    United States

    Active - Recruiting

  • Carteret Medical Group

    Morehead City 4480153, North Carolina 4482348 28557
    United States

    Active - Recruiting

  • West Clinical Research

    Morehead City 4480153, North Carolina 4482348 28557
    United States

    Active - Recruiting

  • Velocity Clinical Research - Cincinnati

    Blue Ash, Ohio 45242
    United States

    Site Not Available

  • Velocity Clinical Research - Springdale

    Cincinnati, Ohio 45246
    United States

    Site Not Available

  • Velocity Clinical Research - Cincinnati

    Blue Ash 4506754, Ohio 5165418 45242
    United States

    Active - Recruiting

  • Velocity Clinical Research - Springdale

    Cincinnati 4508722, Ohio 5165418 45246
    United States

    Active - Recruiting

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island 02818
    United States

    Site Not Available

  • Velocity Clinical Research - Providence

    East Greenwich 5221875, Rhode Island 5224323 02818
    United States

    Active - Recruiting

  • Medical Care LLC

    Elizabethton, Tennessee 37643
    United States

    Site Not Available

  • Medical Care LLC

    Elizabethton 4620634, Tennessee 4662168 37643
    United States

    Active - Recruiting

  • Elligo Clinical Research Center

    Austin, Texas 78704
    United States

    Site Not Available

  • Osvaldo A Brusco MD PA

    Corpus Christi, Texas 78414
    United States

    Site Not Available

  • Cedar Health Research, LLC

    Dallas, Texas 75251
    United States

    Site Not Available

  • Soma Clinical Trials, LLC

    Denison, Texas 75020
    United States

    Site Not Available

  • Cedar Health Research

    Euless, Texas 76040
    United States

    Active - Recruiting

  • Cedar Health Research, LLC

    Euless, Texas 76040
    United States

    Site Not Available

  • Juno Research LLC

    Houston, Texas 77040
    United States

    Site Not Available

  • Tekton Research

    McKinney, Texas 75069
    United States

    Site Not Available

  • Northeast Clinical Research of San Antonio LLC

    San Antonio, Texas 78233
    United States

    Site Not Available

  • Elligo Clinical Research Center

    Austin 4671654, Texas 4736286 78701
    United States

    Active - Recruiting

  • Osvaldo A Brusco MD PA

    Corpus Christi 4683416, Texas 4736286 78414
    United States

    Active - Recruiting

  • Cedar Health Research, LLC

    Dallas 4684888, Texas 4736286 75251
    United States

    Active - Recruiting

  • Soma Clinical Trials, LLC

    Denison 4685892, Texas 4736286 75020
    United States

    Active - Recruiting

  • Cedar Health Research, LLC

    Euless 4689550, Texas 4736286 76040
    United States

    Active - Recruiting

  • Juno Research LLC

    Houston 4699066, Texas 4736286 77054
    United States

    Active - Recruiting

  • Tekton Research

    McKinney 4710178, Texas 4736286 75069
    United States

    Active - Recruiting

  • Northeast Clinical Research of San Antonio LLC

    San Antonio 4726206, Texas 4736286 78233
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research - Layton

    Layton, Utah 84041
    United States

    Site Not Available

  • Alliance for Multispecialty Research - Layton

    Layton 5777107, Utah 5549030 84041
    United States

    Active - Recruiting

  • Manassas Clinical Research Center Inc

    Manassas, Virginia 20110
    United States

    Site Not Available

  • Manassas Clinical Research Center Inc

    Manassas 4771401, Virginia 6254928 20110
    United States

    Active - Recruiting

  • VA Puget Sound Healthcare System

    Seattle, Washington 98108
    United States

    Site Not Available

  • VA Puget Sound Healthcare System

    Seattle 5809844, Washington 5815135 98108
    United States

    Active - Recruiting

  • Ima Clinical Research - West Virginia

    Morgantown, West Virginia 26505
    United States

    Site Not Available

  • Ima Clinical Research - West Virginia

    Morgantown 4815352, West Virginia 4826850 26505
    United States

    Active - Recruiting

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