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New shot shows promise for major weight loss in obesity and diabetes trial

NCT ID NCT05669599

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 study tested three different doses of a new injectable drug called maridebart cafraglutide (AMG 133) against a placebo in 592 adults who were overweight or obese, some with type 2 diabetes. The main goal was to see how much weight participants lost over 52 weeks. The study also tracked how many people achieved 5%, 10%, 15%, or 20% weight loss.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
maridebart cafraglutide (AMG 133)
What this could lead to
If successful, this could lead to a new injectable medication for significant and sustained weight loss in people with obesity or overweight, including those with type 2 diabetes.
What could go wrong
This is a phase 2 dose-ranging study, so it is still early. The drug may not prove effective enough or could have side effects that limit its use. Results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

592 people

The number who actually took part.

Started

Jan 2023

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * Change in body weight greater than 5 kg within 3 months prior to screening. * 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.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity Overweight Type 2 diabetes mellitus

Contacts and locations

Locations

  • Alliance for Multispecialty Research Kansas City

    Kansas City, Missouri, 64114, United States

  • Alliance for Multispecialty Research Miami

    Coral Gables, Florida, 33134, United States

  • Alliance for Multispecialty Research Mobile

    Mobile, Alabama, 36608, United States

  • Alliance for Multispecialty Research Newton

    Newton, Kansas, 67114, United States

  • Alliance for Multispecialty Research Norman

    Norman, Oklahoma, 73069, United States

  • AppleTreeClinics Network Spzoo

    Lodz, 90-349, Poland

  • Ark Clinical Research- Long Beach

    Long Beach, California, 90815, United States

  • Ark Clinical Research- Tustin

    Tustin, California, 92780, United States

  • AthleticoMed

    Bydgoszcz, 85-752, Poland

  • Austin Health, Heidelberg Repatriation Hospital

    Heidelberg Heights, Victoria, 3081, Australia

  • Baker Heart and Diabetes Institute

    Melbourne, Victoria, 3004, Australia

  • Budapesti Szent Ferenc Korhaz

    Budapest, 1021, Hungary

  • CRU Hungary Kft

    Encs, 3860, Hungary

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario, L6S 0C6, Canada

  • Centricity Research Vaughan Endocrinology

    Concord, Ontario, L4K 4M2, Canada

  • Centrum Badan Klinicznych PI-House Spzoo

    Gdansk, 80-546, Poland

  • Centrum Terapii Wspolczesnej

    Lodz, 90-338, Poland

  • Charite - Universitaetsmedizin Berlin, Campus Mitte

    Berlin, 10117, Germany

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Clinexpert Kft

    Budapest, 1033, Hungary

  • Clinical Best Solutions Sp zoo Spolka Komandytowa

    Lublin, 20-078, Poland

  • Clinical Medical and Analytical eXellence CMAX

    Adelaide, South Australia, 5000, Australia

  • Clinical Trials of Texas

    San Antonio, Texas, 78229, United States

  • Clinique des Maladies Lipidiques de Quebec Incorporated

    Québec, Quebec, G1V 4W2, Canada

  • Complexo Hospitalario Universitario A Coruña

    A Coruña, Galicia, 15006, Spain

  • Diabetes and Glandular Disease Clinic

    San Antonio, Texas, 78229, United States

  • Diabeteszentrum Hamburg West

    Hamburg, 22607, Germany

  • Diablo Clinical Research

    Walnut Creek, California, 94598, United States

  • Dongguk University Ilsan Hospital

    Goyang-si, Gyeonggi-do, 10326, South Korea

  • East-West Medical Research

    Honolulu, Hawaii, 96814, United States

  • Endokrinologicky ustav

    Prague, 116 94, Czechia

  • Foothills Research Center

    Phoenix, Arizona, 85044, United States

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640, United States

  • Headlands Research Brownsville

    Brownsville, Texas, 78526, United States

  • HonorHealth

    Scottsdale, Arizona, 85258, United States

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, Andalusia, 29010, Spain

  • Hospital Universitario Arnau de Vilanova Lleida

    Lleida, Catalonia, 25198, Spain

  • Hospital Vithas Sevilla

    Castilleja de la Cuesta, Andalusia, 41950, Spain

  • Institut Universitaire de cardiologie et de pneumologie de Quebec

    Québec, Quebec, G1V 4G5, Canada

  • Institut klinicke a experimentalni mediciny

    Prague, 140 21, Czechia

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Louisville Metabolic and Atherosclerosis Research Center

    Louisville, Kentucky, 40213, United States

  • Lucas Research

    Morehead City, North Carolina, 28557, United States

  • MIH Clinic Yoyogi

    Shibuya-ku, Tokyo, 151-0051, Japan

  • Matsunami Health Promotion Clinic

    Hashima-gun, Gifu, 501-6061, Japan

  • Mazda Hospital of Mazda Motor Corporation

    Aki-gun, Hiroshima, 735-8585, Japan

  • Medical Care LLC

    Elizabethton, Tennessee, 37643, United States

  • Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

    Wroclaw, 52-210, Poland

  • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism

    Matsuyama, Ehime, 790-0034, Japan

  • Monash Medical Centre

    Clayton, Victoria, 3146, Australia

  • Nakakinen Clinic

    Naka, Ibaraki, 311-0113, Japan

  • National Cheng Kung University Hospital

    Tainan, 70403, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Nihonbashi Sakura Clinic

    Chuo-ku, Tokyo, 103-0025, Japan

  • Nishiyamado Keiwa Hospital

    Naka, Ibaraki, 311-0133, Japan

  • Orange County Research Center

    Tustin, California, 92780, United States

  • PanAmerican Clinical Research LLC

    Brownsville, Texas, 78520, United States

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7624, Hungary

  • Pinnacle Clinical Research

    San Antonio, Texas, 78229, United States

  • Prince of Wales Hospital

    Shatin, New Territories, Hong Kong

  • Progressive Medical Research

    Port Orange, Florida, 32127, United States

  • Research Innovations LLC dba Internal Medicine Care Inc

    Beavercreek, Ohio, 45431, United States

  • Royal Prince Alfred Hospital (RPAH) Clinic

    Camperdown, New South Wales, 2006, Australia

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Shiraiwa Medical Clinic

    Kashiwara-shi, Osaka, 582-0005, Japan

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, 3065, Australia

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210, United States

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303, United States

  • Tandem Clinical Research - Marrero

    Marrero, Louisiana, 70072, United States

  • Texas Diabetes Institute

    San Antonio, Texas, 78284, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • Universitaetsmedizin Leipzig

    Leipzig, 04103, Germany

  • University of Calgary

    Calgary, Alberta, T2T 5C7, Canada

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08, Czechia

  • Wellness Tenjin Clinic

    Fukuoka, Fukuoka, 810-0001, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.