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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
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

Full criteria on ClinicalTrials.gov

Sites (77)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Clinical Medical and Analytical eXellence CMAX
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AdelaideAustraliaUnknown status
Royal Prince Alfred Hospital (RPAH) Clinic
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CamperdownAustraliaUnknown status
Monash Medical Centre
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ClaytonAustraliaUnknown status
St Vincents Hospital Melbourne
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FitzroyAustraliaUnknown status
Austin Health - Heidelberg Repatriation Hospital
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Heidelberg HeightsAustraliaUnknown status
Baker Heart and Diabetes Institute
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MelbourneAustraliaUnknown status
Centricity Research Brampton Endocrinology
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BramptonCanadaUnknown status
University Of Calgary
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CalgaryCanadaUnknown status
Centricity Research Vaughan Endocrinology
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ConcordCanadaUnknown status
Clinique des Maladies Lipidiques de Quebec Incorporated
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QuébecCanadaUnknown status
Institut universitaire de cardiologie et de pneumologie de Québec
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QuébecCanadaUnknown status
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaCompleted
Institute for Clinical and Experimental Medicine
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PragueCzechiaCompleted
Endokrinologicky ustav
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PrahaCzechiaCompleted
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
Diabeteszentrum Hamburg West (DZHW) Gemeinschaftspraxis Dr. Wendisch, Dr. Dahl und Prof. Dr. Aberle
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HamburgGermanyCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainCompleted
Hospital Nisa Sevilla Aljarafe
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Castilleja De La CuestaSpainCompleted
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
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LleidaSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
Prince of Wales Hospital
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Shatin, New TerritoriesHong Kong SAR ChinaUnknown status
Budapesti Szent Ferenc Korhaz
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BudapestHungaryCompleted
Clinexpert Kft.
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Budapest IIIHungaryCompleted
CRU Hungary Kft.
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EncsHungaryCompleted
University of Pecs
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PécsHungaryCompleted
Mazda Hospital of Mazda Motor Corporation
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Aki-gunJapanUnknown status
Nihonbashi Sakura Clinic
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Chuo-kuJapanUnknown status
Wellness Tenjin Clinic
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FukuokaJapanUnknown status
Matsunami Health Promotion Clinic
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Hashima-gunJapanUnknown status
Shiraiwa Medical Clinic
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Kashiwara-shiJapanUnknown status
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
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MatsuyamaJapanUnknown status
Nakakinen clinic
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NakaJapanUnknown status
Nishiyamado Keiwa Hospital
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NakaJapanUnknown status
MIH Clinic Yoyogi
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Shibuya-kuJapanUnknown status
Dongguk University Ilsan Hospital
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Goyang-si, Gyeonggi-doSouth KoreaUnknown status
Gachon University Gil Medical Center
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IncheonSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Seongnam-si, Gyeonggi-doSouth KoreaUnknown status
Kangbuk Samsung Hospital
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SeoulSouth KoreaUnknown status
Athleticomed Sp. z o.o.
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BydgoszczPolandCompleted
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandCompleted
Osrodek Badan Klinicznych Bd Research Sp. z o.o.
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IlawaPolandCompleted
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
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LodzPolandCompleted
Clinical Best Solutions Sp. z o.o. S.K.
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LublinPolandCompleted
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
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WroclawPolandCompleted
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Research Innovations LLC dba Internal Medicine Care Inc
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BeavercreekUnited StatesUnknown status
PanAmerican Clinical Research LLC
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BrownsvilleUnited StatesUnknown status
Headlands Research - Brownsville
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BrownsvilleUnited StatesUnknown status
Great Lakes Clinical Trials
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ChicagoUnited StatesUnknown status
University of Chicago
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ChicagoUnited StatesUnknown status
The Christ Hospital
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CincinnatiUnited StatesUnknown status
StudyMetrix Research
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City of Saint PetersUnited StatesUnknown status
Alliance for Multispecialty Research Miami
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Coral GablesUnited StatesUnknown status
Medical Care, LLC
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ElizabethtonUnited StatesUnknown status
East-West Medical Research
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HonoluluUnited StatesUnknown status
Alliance for Multispecialty Research - Kansas City
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Kansas CityUnited StatesUnknown status
Ark Clinical Research - Long Beach
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Long BeachUnited StatesUnknown status
Louisville Metabolic and Atherosclerosis Research Center
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LouisvilleUnited StatesUnknown status
Tandem Clinical Research - Marrero
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MarreroUnited StatesUnknown status
Alliance for Multispecialty Research Mobile
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MobileUnited StatesUnknown status
Lucas Research
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Morehead CityUnited StatesUnknown status
Alliance for Multispecialty Research Newton
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NewtonUnited StatesUnknown status
Alliance for Multispecialty Research - Norman
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NormanUnited StatesUnknown status
Foothills Research Center
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PhoenixUnited StatesUnknown status
Progressive Medical Research
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Port OrangeUnited StatesUnknown status
Pinnacle Clinical Research
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San AntonioUnited StatesUnknown status
Clinical Trials of Texas
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San AntonioUnited StatesUnknown status
Diabetes and Glandular Disease Clinic
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San AntonioUnited StatesUnknown status
Texas Diabetes Institute
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San AntonioUnited StatesUnknown status
HonorHealth
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ScottsdaleUnited StatesUnknown status
State University of New York Upstate Medical University
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SyracuseUnited StatesUnknown status
Orange County Research Center
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TustinUnited StatesUnknown status
Ark Clinical Research- Tustin
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TustinUnited StatesUnknown status
Diablo Clinical Research
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Walnut CreekUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.