Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-1)

October 15, 2025 updated by: Amgen

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

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

Study Overview

Status

Active, not recruiting

Conditions

Obesity

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3853

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- Buenos Aires
  - CABA, Buenos Aires, Argentina, C1426ABP
    - Fundación Respirar
  - CABA, Buenos Aires, Argentina, 1060
    - CEDIC - Centro de Investigacion Clinica
  - CABA, Buenos Aires, Argentina, 1120
    - Centro Medico Viamonte
  - CABA, Buenos Aires, Argentina, C1407GTN
    - Cemedic Centro de Especialidades Medicas
  - CABA, Buenos Aires, Argentina, C1425AGC
    - Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
  - CABA, Buenos Aires, Argentina, C1426ABP
    - Consultorios Medicos Dr Besada
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1056ABI
    - CINME - Centro de Investigaciones Metabolicas
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1061AAT
    - Ciprec - Centro de Investigacion y Prevencion Cardiovascular
Australia
- New South Wales
  - Botany, New South Wales, Australia, 2019
    - Emeritus Research Sydney
  - Charlestown, New South Wales, Australia, 2290
    - Novatrials
  - Miranda, New South Wales, Australia, 2228
    - Canopy Clinical Sutherland
  - St Leonards, New South Wales, Australia, 2065
    - Royal North Shore Hospital
  - Wollongong, New South Wales, Australia, 2500
    - Canopy Clinical Wollongong
- Queensland
  - Meadowbrook, Queensland, Australia, 4131
    - Logan Hospital
- South Australia
  - Norwood, South Australia, Australia, 5067
    - Fusion Clinical Research
  - Oaklands Park, South Australia, Australia, 5046
    - Southern Adelaide Diabetes and Endocrine Services
- Victoria
  - Camberwell, Victoria, Australia, 3124
    - Emeritus Research Camberwell
  - Heidelberg West, Victoria, Australia, 3081
    - Austin Health, Heidelberg Repatriation Hospital
  - North Altona, Victoria, Australia, 3025
    - Canopy Clinical Altona North
Belgium
- - Edegem, Belgium, 2650
    - Universitair Ziekenhuis Antwerpen
  - Ghent, Belgium, 9000
    - Universitair Ziekenhuis Gent
  - Kortrijk, Belgium, 8500
    - Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
  - Leuven, Belgium, 3000
    - Universitair Ziekenhuis Leuven - Campus Gasthuisberg
  - Liège, Belgium, 4000
    - Centre Hospitalier Universitaire de Liege - Sart Tilman
  - Mechelen, Belgium, 2800
    - Algemeen Ziekenhuis Sint-Maarten
  - Mons, Belgium, 7000
    - Centres Hospitaliers Universitaires HELORA - Hôpital de Mons - Site Constantinople
Canada
- British Columbia
  - Surrey, British Columbia, Canada, V3T 2V6
    - TLC Diabetes and Endocrinology
- Ontario
  - Hamilton, Ontario, Canada, L8L 5G8
    - Wharton Medical Clinic
  - North York, Ontario, Canada, M6B 3H7
    - North York Diagnostic and Cardiac Centre
  - Oshawa, Ontario, Canada, L1J 2K9
    - Centricity Research Oshawa Multispecialty
  - Scarborough Village, Ontario, Canada, M1B 4Z8
    - Heart Health Institute Research Incorporated
  - Thunder Bay, Ontario, Canada, P7B 5N3
    - Curans Heart Center
  - Toronto, Ontario, Canada, M6G 1M2
    - Diabetes Heart Research Centre
  - Toronto, Ontario, Canada, M4G 3E8
    - Centricity Research Toronto
- Quebec
  - Chicoutimi, Quebec, Canada, G7H 7K9
    - Ecogene-21
  - Québec, Quebec, Canada, G1V 4G5
    - Institut Universitaire De Cardiologie Et De Pneumologie De Québec
  - Saint-Jean-sur-Richelieu, Quebec, Canada, J3A 1J2
    - CardioVasc HR Incorporated
  - Terrebonne, Quebec, Canada, J6X 4P7
    - Centre de Medecine Metabolique de Lanaudiere
Czechia
- - Brandýs nad Labem, Czechia, 250 01
    - Medicus Services sro
  - Brno, Czechia, 625 00
    - Fakultni Nemocnice Brno
  - Havířov, Czechia, 736 01
    - Endohope Havirov sro
  - Olomouc, Czechia, 779 00
    - PreventaMed sro
  - Ostrava, Czechia, 702 00
    - CCR Ostrava sro
  - Prague, Czechia, 128 08
    - Vseobecna fakultni nemocnice v Praze
  - Prague, Czechia, 140 21
    - Institut klinicke a experimentalni mediciny
  - Prague, Czechia, 100 34
    - Fakultni nemocnice Kralovske Vinohrady
  - Prague, Czechia, 130 00
    - Ob klinika as
  - Prague, Czechia, 150 00
    - Endohope klinika sro
  - Prague, Czechia, 198 00
    - Endokrinologie Cerny Most sro
Denmark
- - Gandrup, Denmark, 9362
    - Sanos Gandrup
  - Hellerup, Denmark, 2900
    - Gentofte Hospital
  - Herlev, Denmark, 2730
    - Sanos Clinic
  - Herlev, Denmark, 2730
    - Steno Diabetes Center Copenhagen
  - Herning, Denmark, 7400
    - Regionshospitalet Godstrup
  - Hvidovre, Denmark, 2650
    - Hvidovre Hospital
Finland
- - Helsinki, Finland, 02290
    - Obesity Research Unit
  - Kuopio, Finland, 70211
    - Health Step Finland
  - Oulu, Finland, 90220
    - Oulu University Hospital
Germany
- - Aachen, Germany, 52074
    - Universitaetsklinikum Aachen
  - Bad Homburg, Germany, 61348
    - Kardiologische Praxis Dr med Wolfgang Jungmair
  - Bad Krozingen, Germany, 79189
    - Universitaets-Herzzentrum Freiburg - Bad Krozingen
  - Bad Mergentheim, Germany, 97980
    - Diabetespraxis Bad Mergentheim
  - Bad Oeynhausen, Germany, 32545
    - Universitaetsklinikum der Ruhr-Universitaet Bochum
  - Berlin, Germany, 13597
    - Mvz am Bahnhof Spandau
  - Berlin, Germany, 13187
    - Diabetespraxis Dr. Hermann Braun
  - Berlin, Germany, 10117
    - Charite - Universitaetsmedizin Berlin, Campus Mitte
  - Berlin, Germany, 10787
    - Velocity Clinical Research GmbH
  - Dresden, Germany, 01307
    - Universitaetsklinikum Dresden
  - Elsterwerda, Germany, 04190
    - Zentrum fuer Klinische Studien Suedbrandenburg GmbH
  - Essen, Germany, 45136
    - InnoDiab Forschung
  - Essen, Germany, 45355
    - Praxis am Markt Dr. Bernd Becker
  - Falkensee, Germany, 14612
    - Schwerpunktpraxis fuer Diabetes, Gefaess- & Ernaehrungsmedizin
  - Frankfurt am Main, Germany, 60596
    - ClinPhenomics CVC GmbH
  - Hamburg, Germany, 22607
    - Diabeteszentrum Hamburg West
  - Hamburg, Germany, 22767
    - Endokrinologikum Hamburg
  - Hohenmölsen, Germany, 06679
    - Diabetologische Schwerpunktpraxis Hohenmoelsen
  - Kassel, Germany, 34121
    - Braun Ambulantes Herzzentrum Kassel
  - Leipzig, Germany, 04103
    - Universitaetsklinikum Leipzig
  - Leipzig, Germany, 04107
    - AmBeNet GmbH
  - Lübeck, Germany, 23538
    - Universitaetsklinikum Schleswig-Holstein - Luebeck
  - Mainz, Germany, 55131
    - Marienhaus Klinikum Mainz
  - Markkleeberg, Germany, 04416
    - Kardiologische Praxis Doktor Jens Taggeselle
  - München, Germany, 80809
    - Centrum für Diagnostik und Gesundheit
  - Münster, Germany, 48145
    - Zentrum fuer Diabtes und Gefaesskrankheiten im Franziskus Carré Muenster
  - Oberwürzbach, Germany, 66386
    - Praxis Segner - Dr. Braun - Kirsch
  - Oldenburg, Germany, 23758
    - RED-Institut GmbH
  - Villingen-Schwenningen, Germany, 78048
    - Gemeinschaftspraxis Prof Jacob/ Dr Jacob
  - Wangen, Germany, 88239
    - Zentrum fuer klinische Forschung Allgaeu Oberschwaben
Italy
- - Bologna, Italy, 40138
    - IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola
  - Chieti, Italy, 66100
    - Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
  - Florence, Italy, 50134
    - Azienda Ospedaliero Universitaria Careggi
  - Milan, Italy, 20138
    - IRCCS Centro Cardiologico Monzino
  - Milan, Italy, 20157
    - Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco
  - Palermo, Italy, 90127
    - Ospedale Civico, Di Cristina e Benfratelli
  - Pisa, Italy, 56126
    - Azienda Ospedaliero Universitaria Pisana
  - Roma, Italy, 00133
    - Fondazione Policlinico Tor Vergata
Japan
- Kanagawa
  - Yokohama, Kanagawa, Japan, 231-0023
    - Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
- Tokyo
  - Chiyoda-ku, Tokyo, Japan, 101-0041
    - Doujin Memorial Foundation, Meiwa Hospital
  - Chuo-ku, Tokyo, Japan, 104-0031
    - Tokyo Asbo Clinic
  - Hachioji-shi, Tokyo, Japan, 192-0046
    - Medical Corp Seikoukai New Medical Research System Clinic
  - Minato-ku, Tokyo, Japan, 108-0075
    - Medical Corporation AOT Shinagawa Strings Clinic
  - Shinjuku-ku, Tokyo, Japan, 160-0004
    - Clinical Research Hospital Tokyo
  - Suginami-ku, Tokyo, Japan, 166-0003
    - Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic
Poland
- - Bialystok, Poland, 15-281
    - Gabinet Leczenia Otylosci i Chorob Dietozaleznych dr hab n med Lucyna Ostrowska
  - Bialystok, Poland, 15-481
    - Kresmed Spolka z Ograniczona Odpowiedzialnoscia
  - Dębica, Poland, 39-200
    - Etg Lublin Spzoo
  - Gdynia, Poland, 81-384
    - Futuremeds spolka z ograniczona odpowiedzialnoscia
  - Katowice, Poland, 40-752
    - Uniwersyteckie Centrum Kliniczne im Prof K Gibinskiego Slaskiego UM w Katowicach
  - Katowice, Poland, 40-772
    - Salvia-Lekston i Madej Spolka Jawna
  - Lodz, Poland, 90-338
    - Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
  - Lublin, Poland, 20-718
    - Ekamed Spolka z Ograniczona Odpowiedzialnoscia
  - Poznan, Poland, 60-589
    - Centrum Zdrowia Metabolicznego Pawel Bogdanski
  - Poznan, Poland, 61-731
    - Clinical Research Center Spzoo Medic-R Spolka Komandytowa
  - Warsaw, Poland, 00-215
    - Futuremeds spolka z ograniczona odpowiedzialnoscia
  - Warsaw, Poland, 00-710
    - Clinical Best Solutions Sp zoo Spolka komandytowa
Puerto Rico
- - Ponce, Puerto Rico, 00717
    - Puerto Rico Medical Research Inc.
  - Ponce, Puerto Rico, 00716
    - Ponce Medical School Foundation Inc
  - San Juan, Puerto Rico, 00909
    - Latin Clinical Trial Center
  - Vega Baja, Puerto Rico, 00694
    - Wellness clinical Research Vega Baja
South Korea
- - Ansan-si, Gyeonggi-do, South Korea, 15355
    - Korea University Ansan Hospital
  - Anyang-si, Gyeonggi-do, South Korea, 14068
    - Hallym University Sacred Heart Hospital
  - Bucheon, Gyeonggi-do, South Korea, 14647
    - The Catholic University of Korea Bucheon St Marys Hospital
  - Busan, South Korea, 49201
    - Dong-A University Hospital
  - Daegu, South Korea, 42415
    - Yeungnam University Medical Center
  - Daegu, South Korea, 41944
    - Kyungpook National University Hospital
  - Daejeon, South Korea, 35233
    - Daejeon Eulji Medical Center, Eulji University
  - Daejeon, South Korea, 35365
    - Konyang University Hospital
  - Goyang-si, Gyeonggi-do, South Korea, 10326
    - Dongguk University Ilsan Hospital
  - Incheon, South Korea, 21565
    - Gachon University Gil Medical Center
  - Seongnam-si, Gyeonggi-do, South Korea, 13620
    - Seoul National University Bundang Hospital
  - Seoul, South Korea, 03080
    - Seoul National University Hospital
  - Seoul, South Korea, 03722
    - Severance Hospital Yonsei University Health System
  - Seoul, South Korea, 03181
    - Kangbuk Samsung Hospital
  - Seoul, South Korea, 07061
    - Seoul Metropolitan Government Seoul National University Boramae Medical Center
  - Seoul, South Korea, 05278
    - KyungHee University Gangdong Hospital
  - Seoul, South Korea, 07345
    - The Catholic University of Korea Yeouido St Marys Hospital
  - Suwon-si Gyeonggi-do, South Korea, 16499
    - Ajou University Hospital
  - Yangsan-si, Gyeongsangnam-do, South Korea, 50612
    - Pusan National University Yangsan Hospital
Spain
- - Palma, Spain, 07014
    - Clínica Juaneda
  - Valencia, Spain, 46017
    - Hospital Universitario Doctor Peset
- Andalusia
  - Almería, Andalusia, Spain, 04009
    - Centro Periferico De Especialidades Bola Azul
  - Castilleja de la Cuesta, Andalusia, Spain, 41950
    - Hospital Vithas Sevilla
  - Huelva, Andalusia, Spain, 21007
    - Hospital Infanta Elena
  - Sanlúcar de Barrameda, Andalusia, Spain, 11540
    - Hospital Virgen del Camino
  - Seville, Andalusia, Spain, 41003
    - Nuevas Tecnologias en Diabetes y Endocrinologia
  - Seville, Andalusia, Spain, 41010
    - Hospital Quironsalud Infanta Luisa
- Galicia
  - A Coruña, Galicia, Spain, 15006
    - Hospital Medico Quirurgico San Rafael
- Madrid
  - Pozuelo de Alarcón, Madrid, Spain, 28223
    - Clinica Ruber SA
- Navarre
  - Pamplona, Navarre, Spain, 31008
    - Clinica Universidad de Navarra
Switzerland
- - Basel, Switzerland, 4031
    - Universitaetsspital Basel
  - Geneva, Switzerland, 1211
    - Hôpitaux universitaires de Genève
  - Sankt Gallen, Switzerland, 9007
    - Kantonsspital Sankt Gallen
  - Sankt Gallen, Switzerland, 9016
    - Stoffwechselzentrum Sankt Gallen
  - Zurich, Switzerland, 8091
    - Universitaetsspital Zuerich
United Kingdom
- - Belfast, United Kingdom, BT28BG
    - Ormeau Clinical Trials Ltd
  - Birmingham, United Kingdom, B21 9RY
    - FutureMeds Birmingham
  - Blackpool, United Kingdom, FY4 3AD
    - Waterloo Medical Centre
  - Blackpool, United Kingdom, FY3 7EN
    - Layton Medical Centre
  - Bristol, United Kingdom, BS10 5NB
    - Southmead Hospital
  - Cornwall, United Kingdom, PL11 2TB
    - The Rame Group Practice
  - Ely, United Kingdom, CB7 5JD
    - Staploe Medical Centre
  - Glasgow, United Kingdom, G20 7BE
    - FutureMeds Glasgow
  - Hull, United Kingdom, HU3 2JZ
    - Hull Royal Infirmary
  - Leicester, United Kingdom, LE5 4PW
    - NIHR Leicestershire & Northamptonshire Commercial Research Delivery Centre
  - Liverpool, United Kingdom, L9 7AL
    - Aintree University Hospital
  - Newcastle upon Tyne, United Kingdom, NE6 1SG
    - FutureMeds Newcastle
  - Penzance, United Kingdom, TR183DX
    - Atlantic Medical Group
  - Rotherham, United Kingdom, S65 1DA
    - Clifton Medical Centre
  - Sandbach, United Kingdom, CW11 1EQ
    - Ashfields Primary Care Centre
United States
- Alabama
  - Anniston, Alabama, United States, 36207
    - Pinnacle Research Group Llc
  - Daphne, Alabama, United States, 36526
    - Alliance For Multispecialty Research - Daphne
  - Mobile, Alabama, United States, 36608
    - Alliance for Multispecialty Research Mobile
- Arizona
  - Phoenix, Arizona, United States, 85044
    - Avacare Foothills Research Center
- California
  - Fountain Valley, California, United States, 92708
    - Ark Clinical Research- Tustin
  - Long Beach, California, United States, 90806
    - Long Beach Clinical Trials Services Inc
  - Long Beach, California, United States, 90815
    - Ark Clinical Research- Long Beach
  - Montclair, California, United States, 91763
    - Catalina Research Institute
  - Riverside, California, United States, 92503
    - Artemis Institute for Clinical Research
  - San Diego, California, United States, 92103
    - Artemis Institute for Clinical Research
  - San Diego, California, United States, 92120
    - Apex Clinical Research
  - Santa Ana, California, United States, 92701
    - Southern California Clinical Research
  - Walnut Creek, California, United States, 94598
    - Diablo Clinical Research
- Connecticut
  - New Haven, Connecticut, United States, 06520
    - Yale School of Medicine
  - Waterbury, Connecticut, United States, 06708
    - Chase Medical Research LLC
- Florida
  - Hialeah, Florida, United States, 33012
    - Indago Research and Health Center
  - Jacksonville, Florida, United States, 32216
    - Jacksonville Center for Clinical Research
  - Jacksonville, Florida, United States, 32256
    - Clinical Neuroscience Solutions - Jacksonville
  - Margate, Florida, United States, 33063
    - South Florida Wellness and Clinical Research Institute
  - Miami, Florida, United States, 33135
    - Optimus U Corporation
  - Miami, Florida, United States, 33173
    - Research Institute of South Florida
  - Ocala, Florida, United States, 34470
    - Renstar Medical Research
  - Orlando, Florida, United States, 32825
    - Florida Institute for Clinical Research
  - Orlando, Florida, United States, 32801
    - Clinical Neuroscience Solutions - Orlando
  - Orlando, Florida, United States, 32807
    - Combined Research Orlando Phase I IV
  - Weston, Florida, United States, 33331
    - Encore Medical Research of Weston LLC
- Georgia
  - Gainesville, Georgia, United States, 30501
    - Center for Advanced Research and Education
  - Union City, Georgia, United States, 30291
    - Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
- Hawaii
  - Honolulu, Hawaii, United States, 96814
    - East-West Medical Research
- Idaho
  - Meridian, Idaho, United States, 83646
    - Solaris Clinical Research
- Illinois
  - Chicago, Illinois, United States, 60640
    - Flourish Research - Great Lakes Clinical Trials
  - Skokie, Illinois, United States, 60077
    - Evanston Premier Healthcare Research LLC
  - Skokie, Illinois, United States, 60077
    - Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie
- Kansas
  - Newton, Kansas, United States, 67114
    - Alliance for Multispecialty Research Newton
- Kentucky
  - Louisville, Kentucky, United States, 40213
    - Louisville Metabolic and Atherosclerosis Research Center
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Velocity Clinical Research - Baton Rouge
  - Marrero, Louisiana, United States, 70072
    - Tandem Clinical Research - Marrero
- Michigan
  - Southfield, Michigan, United States, 48034
    - Headlands Research - Detroit
- Mississippi
  - Fayette, Mississippi, United States, 39069
    - Prime Health and Wellness Sky Clinical Research Network Group
- Missouri
  - Kansas City, Missouri, United States, 64114
    - Alliance for Multispecialty Research - Kansas City
- Nevada
  - Las Vegas, Nevada, United States, 89128
    - Palm Research Center Inc
  - Las Vegas, Nevada, United States, 89128
    - Vector Clinical Trials
- New York
  - Rochester, New York, United States, 14609
    - Rochester Clinical Research
  - Vestal, New York, United States, 13850
    - Velocity Clinical Research- Binghamton
- North Carolina
  - Hickory, North Carolina, United States, 28601
    - Accellacare of Hickory
  - Shelby, North Carolina, United States, 28150
    - Carolina Research Center Inc
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University Health Sciences
- Ohio
  - Cincinnati, Ohio, United States, 45212
    - Clinical Trial Investigator Clinical Research Center
  - Cincinnati, Ohio, United States, 45219
    - Velocity Clinical Research - Cincinnati
- Oklahoma
  - Norman, Oklahoma, United States, 73069
    - Alliance for Multispecialty Research - Norman
- Pennsylvania
  - Newport, Pennsylvania, United States, 17074
    - Capital Area Research LLC
- Rhode Island
  - East Greenwich, Rhode Island, United States, 02818
    - Velocity Clinical Research - Providence
- South Carolina
  - Greenville, South Carolina, United States, 29607
    - Tribe Clinical Research LLC DBA Mountain View Clinical Research
- Tennessee
  - Knoxville, Tennessee, United States, 37909
    - New Phase Research And Development
  - Knoxville, Tennessee, United States, 37938
    - Accellacare US Inc., d/b/a Accellacare of Knoxville
- Texas
  - Austin, Texas, United States, 78704
    - Elligo Clinical Research Center
  - Dallas, Texas, United States, 75251
    - Cedar Health Research, LLC
  - DeSoto, Texas, United States, 75115
    - Epic Medical Research - Texas
  - El Paso, Texas, United States, 79936
    - Great Lakes Research Institute El Paso Research
  - Euless, Texas, United States, 76040
    - Cedar Health Research, LLC
  - Houston, Texas, United States, 77043
    - Biopharma Informatic, LLC
  - Houston, Texas, United States, 77054
    - Juno Research LLC
  - Houston, Texas, United States, 77040
    - Juno Research LLC
  - Mesquite, Texas, United States, 75149
    - Southern Endocrinology Associates PA
  - Pharr, Texas, United States, 78557
    - Great Lakes Research Institute - McAllen Research
  - San Antonio, Texas, United States, 78229
    - Clinical Trials of Texas
  - Sugar Land, Texas, United States, 77479
    - Sugar Lakes Family Practice
- Utah
  - Bountiful, Utah, United States, 84010
    - Pantheon Clinical Research
  - Layton, Utah, United States, 84041
    - Alliance for Multispecialty Research Layton Research Center
  - St. George, Utah, United States, 84770
    - Chrysalis Clinical Research, LLC
- Virginia
  - Arlington, Virginia, United States, 22206
    - Washington Center for Weight Management and Research, Inc
  - Newport News, Virginia, United States, 23606
    - Health Research of Hampton Roads
  - Winchester, Virginia, United States, 22601
    - Selma Medical Associates
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Allegiance Research Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Age ≥ 18 years.
Body mass index ≥ 30 kg/m2 or ≥27 kg/m² to < 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH).
History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maridebart Cafraglutide High Dose Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.	Drug: Maridebart Cafraglutide Maridebart cafraglutide will be administered SC. Other Names: AMG 133 MariTide
Experimental: Maridebart Cafraglutide Medium Dose Participants will receive maridebart cafraglutide medium dose SC for 72 weeks.	Drug: Maridebart Cafraglutide Maridebart cafraglutide will be administered SC. Other Names: AMG 133 MariTide
Experimental: Maridebart Cafraglutide Low Dose Participants will receive maridebart cafraglutide low dose SC for 72 weeks.	Drug: Maridebart Cafraglutide Maridebart cafraglutide will be administered SC. Other Names: AMG 133 MariTide
Placebo Comparator: Placebo Participants will receive placebo SC for 72 weeks.	Drug: Placebo Placebo will be administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change From Baseline in Body Weight at Week 72 Time Frame: Baseline and Week 72	Baseline and Week 72

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of Maridebart Cafraglutide at Week 72 Time Frame: Week 72		Week 72
Change From Baseline in Waist Circumference at Week 72 Time Frame: Baseline and Week 72		Baseline and Week 72
Change From Baseline in Systolic Blood Pressure (SBP) at Week 72 Time Frame: Baseline and Week 72		Baseline and Week 72
Percent Change From Baseline in Fasting Triglycerides at Week 72 Time Frame: Baseline and Week 72		Baseline and Week 72
Change From Baseline in Fasting Glucose at Week 72 Time Frame: Baseline and Week 72		Baseline and Week 72
Change From Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72 Time Frame: Baseline and Week 72	The IWQOL-Lite-CT is a 20-item questionnaire designed to assess the impact of weight on quality of life in clinical trials. Items are scored on a 5-point Likert scale, with raw scores transformed to a 0-100 scale, where higher scores indicate better quality of life and less weight-related impact.	Baseline and Week 72
Change From Baseline in Body Weight at Week 72 Time Frame: Baseline and Week 72		Baseline and Week 72
Change From Baseline in Body Mass Index (BMI) at Week 72 Time Frame: Baseline and Week 72		Baseline and Week 72
Change From Baseline in Hemoglobin A1c at Week 72 Time Frame: Baseline and Week 72		Baseline and Week 72
Percent Change From Baseline in Fasting Insulin at Week 72 Time Frame: Baseline and Week 72		Baseline and Week 72
Change From Baseline in Glycemic Status at Week 72 Time Frame: Baseline and Week 72		Baseline and Week 72
Percent Change From Baseline in Fasting Lipid Parameters at Week 72 Time Frame: Baseline and Week 72	Lipid parameters include: total cholesterol, non-high-density lipoprotein cholesterol (non-HDL-C), low-density lipoprotein cholesterol (LDL-C), very-low-density lipoprotein cholesterol (VLDL-C), and high-density lipoprotein cholesterol (HDL-C).	Baseline and Week 72
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 72 Time Frame: Baseline and Week 72		Baseline and Week 72
Percent Change From Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72 Time Frame: Baseline and Week 72		Baseline and Week 72
Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72 Time Frame: Baseline and Week 72	The SF-36v2 Acute Physical Function domain score measures an individual's ability to perform daily physical activities, such as walking and climbing stairs, over the past week. It includes 10 items scored on a 3-point Likert scale, with raw scores transformed to a 0-100 scale. Higher scores indicate better physical functioning and fewer limitations due to physical health.	Baseline and Week 72
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Time Frame: Up to approximately 88 weeks		Up to approximately 88 weeks
Participant achieving ≥ 5% reduction in body weight from baseline at week 72 Time Frame: Week 72		Week 72
Participant achieving ≥ 10% reduction in body weight from baseline at week 72 Time Frame: Week 72		Week 72
Participant achieving ≥ 15% reduction in body weight from baseline at week 72 Time Frame: Week 72		Week 72
Participant achieving ≥ 20% reduction in body weight from baseline at week 72 Time Frame: Week 72		Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

AmgenTrials clinical trials website

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2025

Primary Completion (Estimated)

January 21, 2027

Study Completion (Estimated)

April 16, 2027

Study Registration Dates

First Submitted

February 28, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 5, 2025

Study Record Updates

Last Update Posted (Actual)

October 20, 2025

Last Update Submitted That Met QC Criteria

October 15, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

20210181
2024-515524-36 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
ICF
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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