NCT05669599CompletedPhase 2
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
A Phase 2 Randomized, Placebo-controlled, Double-blind, 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
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
The study aims to compare and assess the dose response of 3 selected doses of maridebart cafraglutide compared with placebo, on inducing and maintaining weight loss from baseline at Week 52 in participants with overweight or obesity without diabetes mellitus (Cohort A) and in participants with overweight or obesity with Type 2 diabetes mellitus (Cohort B).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 592 (actual)
- First submitted
- 20 Dec 2022
- Start date
- 18 Jan 2023
- Primary completion date
- 8 Oct 2024
- Lead sponsor
- Amgen
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT05669599
- EU CT number
- 2023-510470-13-00
- EudraCT number
- 2022-002470-86
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 592
- From 18 Jan 2023 to the primary completion date, 8 Oct 2024
- 77 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Change in body weight greater than 5 kg within 3 months prior to screening.
Other illness
- 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.
Who the study is looking for
- Age ≥18 years at the time of signing informed consent.
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (77)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Medical and Analytical eXellence CMAX Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Royal Prince Alfred Hospital (RPAH) Clinic Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Monash Medical Centre Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| St Vincents Hospital Melbourne Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| Austin Health - Heidelberg Repatriation Hospital Coordinator of this site? Confirm its status | Heidelberg Heights | Australia | Unknown status |
| Baker Heart and Diabetes Institute Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Centricity Research Brampton Endocrinology Coordinator of this site? Confirm its status | Brampton | Canada | Unknown status |
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Centricity Research Vaughan Endocrinology Coordinator of this site? Confirm its status | Concord | Canada | Unknown status |
| Clinique des Maladies Lipidiques de Quebec Incorporated Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Institut universitaire de cardiologie et de pneumologie de Québec Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| Institute for Clinical and Experimental Medicine Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| Endokrinologicky ustav Coordinator of this site? Confirm its status | Praha | Czechia | Completed |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Diabeteszentrum Hamburg West (DZHW) Gemeinschaftspraxis Dr. Wendisch, Dr. Dahl und Prof. Dr. Aberle Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Completed |
| Hospital Nisa Sevilla Aljarafe Coordinator of this site? Confirm its status | Castilleja De La Cuesta | Spain | Completed |
| Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Coordinator of this site? Confirm its status | Lleida | Spain | Completed |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Shatin, New Territories | Hong Kong SAR China | Unknown status |
| Budapesti Szent Ferenc Korhaz Coordinator of this site? Confirm its status | Budapest | Hungary | Completed |
| Clinexpert Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Completed |
| CRU Hungary Kft. Coordinator of this site? Confirm its status | Encs | Hungary | Completed |
| University of Pecs Coordinator of this site? Confirm its status | Pécs | Hungary | Completed |
| Mazda Hospital of Mazda Motor Corporation Coordinator of this site? Confirm its status | Aki-gun | Japan | Unknown status |
| Nihonbashi Sakura Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Wellness Tenjin Clinic Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Matsunami Health Promotion Clinic Coordinator of this site? Confirm its status | Hashima-gun | Japan | Unknown status |
| Shiraiwa Medical Clinic Coordinator of this site? Confirm its status | Kashiwara-shi | Japan | Unknown status |
| Mikannohana Clinic, Diabetes, Endocrinology and Metabolism Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Nakakinen clinic Coordinator of this site? Confirm its status | Naka | Japan | Unknown status |
| Nishiyamado Keiwa Hospital Coordinator of this site? Confirm its status | Naka | Japan | Unknown status |
| MIH Clinic Yoyogi Coordinator of this site? Confirm its status | Shibuya-ku | Japan | Unknown status |
| Dongguk University Ilsan Hospital Coordinator of this site? Confirm its status | Goyang-si, Gyeonggi-do | South Korea | Unknown status |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si, Gyeonggi-do | South Korea | Unknown status |
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Athleticomed Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Osrodek Badan Klinicznych Bd Research Sp. z o.o. Coordinator of this site? Confirm its status | Ilawa | Poland | Completed |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Clinical Best Solutions Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Research Innovations LLC dba Internal Medicine Care Inc Coordinator of this site? Confirm its status | Beavercreek | United States | Unknown status |
| PanAmerican Clinical Research LLC Coordinator of this site? Confirm its status | Brownsville | United States | Unknown status |
| Headlands Research - Brownsville Coordinator of this site? Confirm its status | Brownsville | United States | Unknown status |
| Great Lakes Clinical Trials Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| The Christ Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| StudyMetrix Research Coordinator of this site? Confirm its status | City of Saint Peters | United States | Unknown status |
| Alliance for Multispecialty Research Miami Coordinator of this site? Confirm its status | Coral Gables | United States | Unknown status |
| Medical Care, LLC Coordinator of this site? Confirm its status | Elizabethton | United States | Unknown status |
| East-West Medical Research Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Alliance for Multispecialty Research - Kansas City Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Ark Clinical Research - Long Beach Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Louisville Metabolic and Atherosclerosis Research Center Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Tandem Clinical Research - Marrero Coordinator of this site? Confirm its status | Marrero | United States | Unknown status |
| Alliance for Multispecialty Research Mobile Coordinator of this site? Confirm its status | Mobile | United States | Unknown status |
| Lucas Research Coordinator of this site? Confirm its status | Morehead City | United States | Unknown status |
| Alliance for Multispecialty Research Newton Coordinator of this site? Confirm its status | Newton | United States | Unknown status |
| Alliance for Multispecialty Research - Norman Coordinator of this site? Confirm its status | Norman | United States | Unknown status |
| Foothills Research Center Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Progressive Medical Research Coordinator of this site? Confirm its status | Port Orange | United States | Unknown status |
| Pinnacle Clinical Research Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Clinical Trials of Texas Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Diabetes and Glandular Disease Clinic Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Texas Diabetes Institute Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| HonorHealth Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| State University of New York Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| Orange County Research Center Coordinator of this site? Confirm its status | Tustin | United States | Unknown status |
| Ark Clinical Research- Tustin Coordinator of this site? Confirm its status | Tustin | United States | Unknown status |
| Diablo Clinical Research Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.