AzTrials
AzTrials

ObesityPhase 3MARITIME-1NCT06858839

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

A Phase 3 study testing Maridebart Cafraglutide in people with Obesity, run by Amgen at 243 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Obesity
What is being tested?
Maridebart Cafraglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,853 participants
Where
243 sitesin 17 countries
Study dates
12 Mar 2025to 16 Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

243 sites in 17 countries.

243 sites in 17 countries

United States74 sites

  • Pinnacle Research Group LLC

    Anniston, Alabama, 36207

  • Washington Center for Weight Management and Research, Inc

    Arlington, Virginia, 22206

  • Elligo Clinical Research Center

    Austin, Texas, 78704

  • Velocity Clinical Research - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Pantheon Clinical Research

    Bountiful, Utah, 84010

  • Flourish Research - Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • Clinical Trial Investigator Clinical Research Center

    Cincinnati, Ohio, 45212

  • Velocity Clinical Research - Cincinnati

    Cincinnati, Ohio, 45219

  • Cedar Health Research, LLC

    Dallas, Texas, 75251

  • Alliance For Multispecialty Research - Daphne

    Daphne, Alabama, 36526

  • Epic Medical Research - Texas

    DeSoto, Texas, 75115

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island, 02818

  • Great Lakes Research Institute El Paso Research

    El Paso, Texas, 79936

  • Cedar Health Research, LLC

    Euless, Texas, 76040

  • Prime Health and Wellness Sky Clinical Research Network Group

    Fayette, Mississippi, 39069

  • Ark Clinical Research- Tustin

    Fountain Valley, California, 92708

  • Center for Advanced Research and Education

    Gainesville, Georgia, 30501

  • Tribe Clinical Research LLC Dba Mountain View Clinical Research

    Greenville, South Carolina, 29607

  • Indago Research and Health Center

    Hialeah, Florida, 33012

  • Accellacare of Hickory

    Hickory, North Carolina, 28601

  • East-West Medical Research

    Honolulu, Hawaii, 96814

  • Juno Research LLC

    Houston, Texas, 77040

  • Biopharma Informatic, LLC

    Houston, Texas, 77043

  • Juno Research LLC

    Houston, Texas, 77054

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Clinical Neuroscience Solutions - Jacksonville

    Jacksonville, Florida, 32256

  • Alliance for Multispecialty Research - Kansas City

    Kansas City, Missouri, 64114

  • New Phase Research and Development

    Knoxville, Tennessee, 37909

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

    Knoxville, Tennessee, 37938

  • Palm Research Center Inc

    Las Vegas, Nevada, 89128

  • Vector Clinical Trials

    Las Vegas, Nevada, 89128

  • Alliance for Multispecialty Research Layton Research Center

    Layton, Utah, 84041

  • Long Beach Clinical Trials Services Inc

    Long Beach, California, 90806

  • Ark Clinical Research- Long Beach

    Long Beach, California, 90815

  • Louisville Metabolic and Atherosclerosis Research Center

    Louisville, Kentucky, 40213

  • South Florida Wellness and Clinical Research Institute

    Margate, Florida, 33063

  • Tandem Clinical Research - Marrero

    Marrero, Louisiana, 70072

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • Southern Endocrinology Associates PA

    Mesquite, Texas, 75149

  • Optimus U Corporation

    Miami, Florida, 33135

  • Research Institute of South Florida

    Miami, Florida, 33173

  • Allegiance Research Specialists

    Milwaukee, Wisconsin, 53226

  • Alliance for Multispecialty Research Mobile

    Mobile, Alabama, 36608

  • Catalina Research Institute

    Montclair, California, 91763

  • Yale School of Medicine

    New Haven, Connecticut, 06520

  • Capital Area Research LLC

    Newport, Pennsylvania, 17074

  • Health Research of Hampton Roads

    Newport News, Virginia, 23606

  • Alliance for Multispecialty Research Newton

    Newton, Kansas, 67114

  • Alliance for Multispecialty Research - Norman

    Norman, Oklahoma, 73069

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Clinical Neuroscience Solutions - Orlando

    Orlando, Florida, 32801

  • Combined Research Orlando Phase I IV

    Orlando, Florida, 32807

  • Florida Institute for Clinical Research

    Orlando, Florida, 32825

  • Great Lakes Research Institute - McAllen Research

    Pharr, Texas, 78557

  • Avacare Foothills Research Center

    Phoenix, Arizona, 85044

  • Artemis Institute for Clinical Research

    Riverside, California, 92503

  • Rochester Clinical Research

    Rochester, New York, 14609

  • Clinical Trials of Texas

    San Antonio, Texas, 78229

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Apex Clinical Research

    San Diego, California, 92120

  • Southern California Clinical Research

    Santa Ana, California, 92701

  • Carolina Research Center Inc

    Shelby, North Carolina, 28150

  • Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie

    Skokie, Illinois, 60077

  • Evanston Premier Healthcare Research LLC

    Skokie, Illinois, 60077

  • Headlands Research - Detroit

    Southfield, Michigan, 48034

  • Chrysalis Clinical Research, LLC

    St. George, Utah, 84770

  • Sugar Lakes Family Practice

    Sugar Land, Texas, 77479

  • Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group

    Union City, Georgia, 30291

  • Velocity Clinical Research- Binghamton

    Vestal, New York, 13850

  • Diablo Clinical Research

    Walnut Creek, California, 94598

  • Chase Medical Research LLC

    Waterbury, Connecticut, 06708

  • Encore Medical Research of Weston LLC

    Weston, Florida, 33331

  • Selma Medical Associates

    Winchester, Virginia, 22601

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany30 sites

  • Universitaetsklinikum Aachen

    Aachen, 52074

  • Kardiologische Praxis Dr med Wolfgang Jungmair

    Bad Homburg, 61348

  • Universitaets-Herzzentrum Freiburg - Bad Krozingen

    Bad Krozingen, 79189

  • Diabetespraxis Bad Mergentheim

    Bad Mergentheim, 97980

  • Universitaetsklinikum der Ruhr-Universitaet Bochum

    Bad Oeynhausen, 32545

  • Charite - Universitaetsmedizin Berlin, Campus Mitte

    Berlin, 10117

  • Velocity Clinical Research GmbH

    Berlin, 10787

  • Diabetespraxis Dr. Hermann Braun

    Berlin, 13187

  • Mvz am Bahnhof Spandau

    Berlin, 13597

  • Universitaetsklinikum Dresden

    Dresden, 01307

  • Zentrum fuer Klinische Studien Suedbrandenburg GmbH

    Elsterwerda, 04190

  • InnoDiab Forschung

    Essen, 45136

  • Praxis am Markt Dr. Bernd Becker

    Essen, 45355

  • Schwerpunktpraxis fuer Diabetes, Gefaess- & Ernaehrungsmedizin

    Falkensee, 14612

  • ClinPhenomics CVC GmbH

    Frankfurt am Main, 60596

  • Diabeteszentrum Hamburg West

    Hamburg, 22607

  • Endokrinologikum Hamburg

    Hamburg, 22767

  • Diabetologische Schwerpunktpraxis Hohenmoelsen

    Hohenmölsen, 06679

  • Braun Ambulantes Herzzentrum Kassel

    Kassel, 34121

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

  • AmBeNet GmbH

    Leipzig, 04107

  • Universitaetsklinikum Schleswig-Holstein - Luebeck

    Lübeck, 23538

  • Marienhaus Klinikum Mainz

    Mainz, 55131

  • Kardiologische Praxis Doktor Jens Taggeselle

    Markkleeberg, 04416

  • Centrum für Diagnostik und Gesundheit

    München, 80809

  • Zentrum fuer Diabtes und Gefaesskrankheiten im Franziskus Carré Muenster

    Münster, 48145

  • Praxis Segner - Dr. Braun - Kirsch

    Oberwürzbach, 66386

  • Red-Institut GmbH

    Oldenburg, 23758

  • Gemeinschaftspraxis Prof Jacob/ Dr Jacob

    Villingen-Schwenningen, 78048

  • Zentrum fuer klinische Forschung Allgaeu Oberschwaben

    Wangen, 88239

Other trials in Germany

South Korea19 sites

  • Korea University Ansan Hospital

    Ansan-si, Gyeonggi-do, 15355

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do, 14068

  • The Catholic University of Korea Bucheon St Marys Hospital

    Bucheon, Gyeonggi-do, 14647

  • Dong-A University Hospital

    Busan, 49201

  • Kyungpook National University Hospital

    Daegu, 41944

  • Yeungnam University Medical Center

    Daegu, 42415

  • Daejeon Eulji Medical Center, Eulji University

    Daejeon, 35233

  • Konyang University Hospital

    Daejeon, 35365

  • Dongguk University Ilsan Hospital

    Goyang-si, Gyeonggi-do, 10326

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • KyungHee University Gangdong Hospital

    Seoul, 05278

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul, 07061

  • The Catholic University of Korea Yeouido St Marys Hospital

    Seoul, 07345

  • Ajou University Hospital

    Suwon-si Gyeonggi-do, 16499

  • Pusan National University Yangsan Hospital

    Yangsan-si, Gyeongsangnam-do, 50612

Other trials in South Korea

United Kingdom15 sites

  • Ormeau Clinical Trials Ltd

    Belfast, BT28BG

  • FutureMeds Birmingham

    Birmingham, B21 9RY

  • Layton Medical Centre

    Blackpool, FY3 7EN

  • Waterloo Medical Centre

    Blackpool, FY4 3AD

  • Southmead Hospital

    Bristol, BS10 5NB

  • The Rame Group Practice

    Cornwall, PL11 2TB

  • Staploe Medical Centre

    Ely, CB7 5JD

  • FutureMeds Glasgow

    Glasgow, G20 7BE

  • Hull Royal Infirmary

    Hull, HU3 2JZ

  • NIHR Leicestershire & Northamptonshire Commercial Research Delivery Centre

    Leicester, LE5 4PW

  • Aintree University Hospital

    Liverpool, L9 7AL

  • FutureMeds Newcastle

    Newcastle upon Tyne, NE6 1SG

  • Atlantic Medical Group

    Penzance, TR183DX

  • Clifton Medical Centre

    Rotherham, S65 1DA

  • Ashfields Primary Care Centre

    Sandbach, CW11 1EQ

Other trials in United Kingdom

Canada12 sites

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9

  • Wharton Medical Clinic

    Hamilton, Ontario, L8L 5G8

  • North York Diagnostic and Cardiac Centre

    North York, Ontario, M6B 3H7

  • Centricity Research Oshawa Multispecialty

    Oshawa, Ontario, L1J 2K9

  • Institut Universitaire de cardiologie et de pneumologie de Quebec

    Québec, Quebec, G1V 4G5

  • CardioVasc HR Incorporated

    Saint-Jean-sur-Richelieu, Quebec, J3A 1J2

  • Heart Health Institute Research Incorporated

    Scarborough Village, Ontario, M1B 4Z8

  • tlc Diabetes and Endocrinology

    Surrey, British Columbia, V3T 2V6

  • Centre de Medecine Metabolique de Lanaudiere

    Terrebonne, Quebec, J6X 4P7

  • Curans Heart Center

    Thunder Bay, Ontario, P7B 5N3

  • Centricity Research Toronto

    Toronto, Ontario, M4G 3E8

  • Diabetes Heart Research Centre

    Toronto, Ontario, M6G 1M2

Other trials in Canada

Poland12 sites

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

    Bialystok, 15-281

  • Kresmed Spolka z Ograniczona Odpowiedzialnoscia

    Bialystok, 15-481

  • Etg Lublin Spzoo

    Dębica, 39-200

  • Futuremeds Spolka z ograniczona odpowiedzialnoscia

    Gdynia, 81-384

  • Uniwersyteckie Centrum Kliniczne im Prof K Gibinskiego Slaskiego UM w Katowicach

    Katowice, 40-752

  • Salvia-Lekston i Madej Spolka Jawna

    Katowice, 40-772

  • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

    Lodz, 90-338

  • Ekamed Spolka z Ograniczona Odpowiedzialnoscia

    Lublin, 20-718

  • Centrum Zdrowia Metabolicznego Pawel Bogdanski

    Poznan, 60-589

  • Clinical Research Center Spzoo Medic-R Spolka Komandytowa

    Poznan, 61-731

  • Futuremeds Spolka z ograniczona odpowiedzialnoscia

    Warsaw, 00-215

  • Clinical Best Solutions Sp zoo Spolka komandytowa

    Warsaw, 00-710

Other trials in Poland

Australia11 sites

  • Emeritus Research Sydney

    Botany, New South Wales, 2019

  • Emeritus Research Camberwell

    Camberwell, Victoria, 3124

  • Novatrials

    Charlestown, New South Wales, 2290

  • Austin Health, Heidelberg Repatriation Hospital

    Heidelberg West, Victoria, 3081

  • Logan Hospital

    Meadowbrook, Queensland, 4131

  • Canopy Clinical Sutherland

    Miranda, New South Wales, 2228

  • Canopy Clinical Altona North

    North Altona, Victoria, 3025

  • Fusion Clinical Research

    Norwood, South Australia, 5067

  • Southern Adelaide Diabetes and Endocrine Services

    Oaklands Park, South Australia, 5046

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Canopy Clinical Wollongong

    Wollongong, New South Wales, 2500

Other trials in Australia

Czechia11 sites

  • Medicus Services sro

    Brandýs nad Labem, 250 01

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Endohope Havirov sro

    Havířov, 736 01

  • PreventaMed sro

    Olomouc, 779 00

  • CCR Ostrava sro

    Ostrava, 702 00

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

  • Ob klinika as

    Prague, 130 00

  • Institut klinicke a experimentalni mediciny

    Prague, 140 21

  • Endohope klinika sro

    Prague, 150 00

  • Endokrinologie Cerny Most sro

    Prague, 198 00

Other trials in Czechia

Spain11 sites

  • Hospital Medico Quirurgico San Rafael

    A Coruña, Galicia, 15006

  • Centro Periferico de Especialidades Bola Azul

    Almería, Andalusia, 04009

  • Hospital Vithas Sevilla

    Castilleja de la Cuesta, Andalusia, 41950

  • Hospital Infanta Elena

    Huelva, Andalusia, 21007

  • Clinica Juaneda

    Palma, 07014

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Clinica Ruber SA

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Virgen del Camino

    Sanlúcar de Barrameda, Andalusia, 11540

  • Nuevas Tecnologias en Diabetes y Endocrinologia

    Seville, Andalusia, 41003

  • Hospital Quironsalud Infanta Luisa

    Seville, Andalusia, 41010

  • Hospital Universitario Doctor Peset

    Valencia, 46017

Other trials in Spain

Argentina8 sites

  • Cedic - Centro de Investigacion Clinica

    CABA, Buenos Aires, 1060

  • Centro Medico Viamonte

    CABA, Buenos Aires, 1120

  • Cemedic Centro de Especialidades Medicas

    CABA, Buenos Aires, C1407GTN

  • Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

    CABA, Buenos Aires, C1425AGC

  • Consultorios Medicos Dr Besada

    CABA, Buenos Aires, C1426ABP

  • Fundacion Respirar

    CABA, Buenos Aires, C1426ABP

  • Cinme - Centro de Investigaciones Metabolicas

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1056ABI

  • Ciprec - Centro de Investigacion y Prevencion Cardiovascular

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1061AAT

Other trials in Argentina

Italy8 sites

  • IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola

    Bologna, 40138

  • Universita degli Studi Gabriele D Annunzio di Chieti e Pescara

    Chieti, 66100

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134

  • IRCCS Centro Cardiologico Monzino

    Milan, 20138

  • Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco

    Milan, 20157

  • Ospedale Civico, Di Cristina e Benfratelli

    Palermo, 90127

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Fondazione Policlinico Tor Vergata

    Roma, 00133

Other trials in Italy

Belgium7 sites

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Algemeen Ziekenhuis Groeninge - Campus Kennedylaan

    Kortrijk, 8500

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 4000

  • Algemeen Ziekenhuis Sint-Maarten

    Mechelen, 2800

  • Centres Hospitaliers Universitaires HELORA - Hôpital de Mons - Site Constantinople

    Mons, 7000

Other trials in Belgium

Japan7 sites

  • Doujin Memorial Foundation, Meiwa Hospital

    Chiyoda-ku, Tokyo, 101-0041

  • Tokyo Asbo Clinic

    Chuo-ku, Tokyo, 104-0031

  • Medical Corp Seikoukai New Medical Research System Clinic

    Hachioji-shi, Tokyo, 192-0046

  • Medical Corporation AOT Shinagawa Strings Clinic

    Minato-ku, Tokyo, 108-0075

  • Clinical Research Hospital Tokyo

    Shinjuku-ku, Tokyo, 160-0004

  • Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic

    Suginami-ku, Tokyo, 166-0003

  • Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic

    Yokohama, Kanagawa, 231-0023

Other trials in Japan

Denmark6 sites

  • Sanos Gandrup

    Gandrup, 9362

  • Gentofte Hospital

    Hellerup, 2900

  • Sanos Clinic

    Herlev, 2730

  • Steno Diabetes Center Copenhagen

    Herlev, 2730

  • Regionshospitalet Godstrup

    Herning, 7400

  • Hvidovre Hospital

    Hvidovre, 2650

Other trials in Denmark

Switzerland5 sites

  • Universitaetsspital Basel

    Basel, 4031

  • Hopitaux Universitaires de Geneve

    Geneva, 1211

  • Kantonsspital Sankt Gallen

    Sankt Gallen, 9007

  • Stoffwechselzentrum Sankt Gallen

    Sankt Gallen, 9016

  • Universitaetsspital Zuerich

    Zurich, 8091

Other trials in Switzerland

Puerto Rico4 sites

  • Ponce Medical School Foundation Inc

    Ponce, 00716

  • Puerto Rico Medical Research Inc.

    Ponce, 00717

  • Latin Clinical Trial Center

    San Juan, 00909

  • Wellness Clinical Research Vega Baja

    Vega Baja, 00694

Other trials in Puerto Rico

Finland3 sites

  • Obesity Research Unit

    Helsinki, 02290

  • Health Step Finland

    Kuopio, 70211

  • Oulu University Hospital

    Oulu, 90220

Other trials in Finland

About this study

Official title: 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.

Conditions
Obesity
Being tested
Maridebart Cafraglutide, Placebo
Keywords
Overweight, BMI, Body weight, Maridebart cafraglutide, Chronic weight management, MariTide
Medical subject headings
Obesity, Overweight, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maridebart CafraglutideDrug

    Also called AMG 133, MariTide

    Maridebart cafraglutide will be administered SC.

  • PlaceboDrug

    Placebo will be administered SC.

Study groups in NCT06858839
Study groupRoleWhat they receive
Maridebart Cafraglutide High DoseExperimentalParticipants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.
Receives: Drug: Maridebart Cafraglutide
Maridebart Cafraglutide Medium DoseExperimentalParticipants will receive maridebart cafraglutide medium dose SC for 72 weeks.
Receives: Drug: Maridebart Cafraglutide
Maridebart Cafraglutide Low DoseExperimentalParticipants will receive maridebart cafraglutide low dose SC for 72 weeks.
Receives: Drug: Maridebart Cafraglutide
PlaceboPlacebo comparatorParticipants will receive placebo SC for 72 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline in Body Weight at Week 72

    Measured: Baseline and Week 72

Secondary outcomes (20)

  1. Change From Baseline in Waist Circumference at Week 72

    Measured: Baseline and Week 72

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

    Measured: Week 72

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

    Measured: Week 72

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

    Measured: Week 72

  5. Participant achieving ≥ 20% reduction in body weight from baseline at week 72

    Measured: Week 72

  6. Change From Baseline in Systolic Blood Pressure (SBP) at Week 72

    Measured: Baseline and Week 72

  7. Percent Change From Baseline in Fasting Triglycerides at Week 72

    Measured: Baseline and Week 72

  8. Change From Baseline in Fasting Glucose at Week 72

    Measured: Baseline and Week 72

  9. 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

    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.

    Measured: Baseline and Week 72

  10. Change From Baseline in Body Weight at Week 72

    Measured: Baseline and Week 72

  11. Change From Baseline in Body Mass Index (BMI) at Week 72

    Measured: Baseline and Week 72

  12. Change From Baseline in Hemoglobin A1c at Week 72

    Measured: Baseline and Week 72

  13. Percent Change From Baseline in Fasting Insulin at Week 72

    Measured: Baseline and Week 72

  14. Change From Baseline in Glycemic Status at Week 72

    Measured: Baseline and Week 72

  15. Percent Change From Baseline in Fasting Lipid Parameters at 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).

    Measured: Baseline and Week 72

  16. Change From Baseline in Diastolic Blood Pressure (DBP) at Week 72

    Measured: Baseline and Week 72

  17. Percent Change From Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72

    Measured: Baseline and Week 72

  18. Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at 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.

    Measured: Baseline and Week 72

  19. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Measured: Up to approximately 88 weeks

  20. Plasma Concentration of Maridebart Cafraglutide at Week 72

    Measured: Week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2025
  2. Study start12 Mar 2025
  3. Primary completion21 Jan 2027 (estimated)
  4. Study completion16 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
3,853 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06858839
Sponsor's protocol ID
20210181
Other IDs
2024-515524-36
Acronym
MARITIME-1
Status last verified
Sep 2026
First submitted
28 Feb 2025
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Maridebart Cafraglutide in people with Obesity, run by Amgen at 243 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 243 sites in United States, Germany, South Korea, United Kingdom, Canada and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Body Weight at Week 72 (time frame: Baseline and Week 72). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06858839.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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