Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus
NCT ID: NCT05669599
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
592 participants
INTERVENTIONAL
2023-01-18
2025-12-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort A: Maridebart Cafraglutide
Part 1: Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 7 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts.
Maridebart Cafraglutide
Participants will receive maridebart cafraglutide by subcutaneous (SC) injection.
Placebo
Participants will receive placebo by SC injection.
Cohort A: Placebo
Part 1: Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 7 dose cohorts . Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts.
Maridebart Cafraglutide
Participants will receive maridebart cafraglutide by subcutaneous (SC) injection.
Placebo
Participants will receive placebo by SC injection.
Cohort B: Maridebart Cafraglutide
Part 1: Cohort B will consist of participants with a diagnosis of type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 4 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts.
Maridebart Cafraglutide
Participants will receive maridebart cafraglutide by subcutaneous (SC) injection.
Placebo
Participants will receive placebo by SC injection.
Cohort B: Placebo
Part 1: Cohort B will consist of participants with a diagnosis of type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 4 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts.
Maridebart Cafraglutide
Participants will receive maridebart cafraglutide by subcutaneous (SC) injection.
Placebo
Participants will receive placebo by SC injection.
Interventions
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Maridebart Cafraglutide
Participants will receive maridebart cafraglutide by subcutaneous (SC) injection.
Placebo
Participants will receive placebo by SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI ≥30 kg/m\^2, or ≥27 kg/m\^2 and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease.
* For participants in cohort B only, HbA1c ≥ 7% and ≤ 10% (53 to 86 mmol/mol) at screening with an established diagnosis of type 2 diabetes mellitus for ≥ 180 days prior to screening and either treated with diet and exercise alone or on stable (at least 90 days prior to screening) treatment with metformin, a sulfonylurea, or a sodium-glucose cotransporter 2 (SGLT2) inhibitor as monotherapy or combination therapy, per approved local label.
* History of at least one unsuccessful dietary effort to lose body weight.
Exclusion Criteria
* Obesity induced by other endocrinologic disorders.
* History of pancreatitis.
* Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2).
* History of major depressive disorder within the last 2 years.
* Any lifetime history of other major psychiatric disorder or suicide attempt.
18 Years
99 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Alliance for Multispecialty Research Mobile
Mobile, Alabama, United States
Foothills Research Center
Phoenix, Arizona, United States
HonorHealth
Scottsdale, Arizona, United States
Ark Clinical Research- Long Beach
Long Beach, California, United States
Ark Clinical Research- Tustin
Tustin, California, United States
Orange County Research Center
Tustin, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Alliance for Multispecialty Research Miami
Coral Gables, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
East-West Medical Research
Honolulu, Hawaii, United States
University of Chicago
Chicago, Illinois, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Alliance for Multispecialty Research Newton
Newton, Kansas, United States
Louisville Metabolic and Atherosclerosis Research Center
Louisville, Kentucky, United States
Tandem Clinical Research - Marrero
Marrero, Louisiana, United States
StudyMetrix Research
City of Saint Peters, Missouri, United States
Alliance for Multispecialty Research Kansas City
Kansas City, Missouri, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Lucas Research
Morehead City, North Carolina, United States
Research Innovations LLC dba Internal Medicine Care Inc
Beavercreek, Ohio, United States
The Christ Hospital
Cincinnati, Ohio, United States
Alliance for Multispecialty Research Norman
Norman, Oklahoma, United States
Medical Care LLC
Elizabethton, Tennessee, United States
PanAmerican Clinical Research LLC
Brownsville, Texas, United States
Headlands Research Brownsville
Brownsville, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Diabetes and Glandular Disease Clinic
San Antonio, Texas, United States
Pinnacle Clinical Research
San Antonio, Texas, United States
Texas Diabetes Institute
San Antonio, Texas, United States
Royal Prince Alfred Hospital (RPAH) Clinic
Camperdown, New South Wales, Australia
Clinical Medical and Analytical eXellence CMAX
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Austin Health, Heidelberg Repatriation Hospital
Heidelberg Heights, Victoria, Australia
Baker Heart and Diabetes Institute
Melbourne, Victoria, Australia
University of Calgary
Calgary, Alberta, Canada
Centricity Research Brampton Endocrinology
Brampton, Ontario, Canada
Centricity Research Vaughan Endocrinology
Concord, Ontario, Canada
Institut Universitaire de cardiologie et de pneumologie de Quebec
Québec, Quebec, Canada
Clinique des Maladies Lipidiques de Quebec Incorporated
Québec, Quebec, Canada
Endokrinologicky ustav
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Institut klinicke a experimentalni mediciny
Prague, , Czechia
Charite - Universitaetsmedizin Berlin, Campus Mitte
Berlin, , Germany
Diabeteszentrum Hamburg West
Hamburg, , Germany
Universitaetsmedizin Leipzig
Leipzig, , Germany
Prince of Wales Hospital
Shatin, New Territories, , Hong Kong
Budapesti Szent Ferenc Korhaz
Budapest, , Hungary
Clinexpert Kft
Budapest, , Hungary
CRU Hungary Kft
Encs, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, , Hungary
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
Matsuyama, Ehime, Japan
Wellness Tenjin Clinic
Fukuoka, Fukuoka, Japan
Matsunami Health Promotion Clinic
Hashima-gun, Gifu, Japan
Mazda Hospital of Mazda Motor Corporation
Aki-gun, Hiroshima, Japan
Nakakinen Clinic
Naka, Ibaraki, Japan
Nishiyamado Keiwa Hospital
Naka, Ibaraki, Japan
Shiraiwa Medical Clinic
Kashiwara-shi, Osaka, Japan
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo, Japan
MIH Clinic Yoyogi
Shibuya-ku, Tokyo, Japan
AthleticoMed
Bydgoszcz, , Poland
Centrum Badan Klinicznych PI-House Spzoo
Gdansk, , Poland
Centrum Terapii Wspolczesnej
Lodz, , Poland
AppleTreeClinics Network Spzoo
Lodz, , Poland
Clinical Best Solutions Sp zoo Spolka Komandytowa
Lublin, , Poland
Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, , Poland
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Hospital Vithas Sevilla
Castilleja de la Cuesta, Andalusia, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Andalusia, Spain
Hospital Universitario Arnau de Vilanova Lleida
Lleida, Catalonia, Spain
Complexo Hospitalario Universitario A Coruña
A Coruña, Galicia, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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References
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Jastreboff AM, Ryan DH, Bays HE, Ebeling PR, Mackowski MG, Philipose N, Ross L, Liu Y, Burns CE, Abbasi SA, Pannacciulli N; MariTide Phase 2 Obesity Trial Investigators. Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity - A Phase 2 Trial. N Engl J Med. 2025 Sep 4;393(9):843-857. doi: 10.1056/NEJMoa2504214. Epub 2025 Jun 23.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2023-510470-13-00
Identifier Type: CTIS
Identifier Source: secondary_id
20190218
Identifier Type: -
Identifier Source: org_study_id
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