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New diabetes drug shows promise in Mid-Stage trial

NCT ID NCT06660173

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This Phase 2 study tests a new injectable drug called maridebart cafraglutide in 409 adults with type 2 diabetes. The main goal is to see if it improves blood sugar control compared to a placebo. Researchers will also check if it helps with weight loss. The trial is active but no longer recruiting.

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 that helps control blood sugar and reduce body weight in people with type 2 diabetes.
What could go wrong
This is a Phase 2 trial, so it's still early. The drug may not work better than placebo, and side effects are possible. Results may not apply to all diabetes patients.

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

409 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

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 years and older

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 screening (or ≥ legal age within the country if it is older than 18 years) * Type 2 diabetes for ≥6 months according to the World Health Organization classification * HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory * Treatment of diabetes with diet and exercise alone, or with a stable dose of metformin, with or without a sodium-glucose cotransporter-2 inhibitor, for at least 3 months prior to screening * Body mass index of 23 to 50 kilograms per square meter Exclusion Criteria: * Type 1 diabetes * Use of any glucose-lowering medication, other than metformin with or without a sodium-glucose cotransporter-2 inhibitor, within 3 months prior to screening * Estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology equation. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy * History of acute or chronic pancreatitis * Malignancy within 5 years before screening, except for nonmelanoma skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer * Myocardial infarction, unstable angina, coronary artery bypass graft surgery or other major cardiovascular surgery, percutaneous coronary intervention, transient ischemic attack, cerebrovascular accident, or decompensated congestive heart failure within 90 days prior to screening, or currently have New York Heart Association Class III or IV heart failure. * Use of medications that affect glucose control or body weight or history of bariatric surgery or procedures.

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Conditions

The condition(s) this trial relates to.

Obesity type 2 diabetes mellitus

As listed by the trial registrant

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

Type 2 diabetes mellitus (T2DM)

Contacts and locations

Locations

  • Accel Research Site - Birmingham Clinical Research Unit

    Birmingham, Alabama, 35216, United States

  • Accel Research Site - Neurostudies

    Decatur, Georgia, 30030, United States

  • Alliance for Multispecialty Research

    Norman, Oklahoma, 73069, United States

  • Anaheim Clinical Trials

    Anaheim, California, 92801, United States

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Athens Medical Center S.A - Iatriko Amarousiou

    Marousi, 15125, Greece

  • Athens Medical Center- Iatriko Paleou Falirou

    Palaió Fáliro, 17562, Greece

  • Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco

    Milan, 20157, Italy

  • Azienda Universitaria Ospedaliera Consorziale Policlinico Bari

    Bari, 70124, Italy

  • Be Well Clinical Studies

    Round Rock, Texas, 78681, United States

  • Borbanya Praxis Egeszsegugyi Kft

    Nyíregyháza, 4405, Hungary

  • CRU Hungary Kft

    Encs, 3860, Hungary

  • Cedar Crosse Research and Health Care

    Chicago, Illinois, 60607, United States

  • Centrul pentru Studiul Metabolismului - Hightech Medical Services SRL

    Bucharest, 011052, Romania

  • Centrum Badan Klinicznych Piotr Napora lekarze spolka partnerska

    Wroclaw, 51-162, Poland

  • Charlottesville Medical Research Center

    Charlottesville, Virginia, 22911, United States

  • Clinexpert Kft

    Budapest, 1033, Hungary

  • Clinica Korall

    Satu Mare, 440055, Romania

  • Complexo Hospitalario Universitario A Coruña

    A Coruña, Galicia, 15006, Spain

  • Conquest Research - Winter Park

    Winter Park, Florida, 32789, United States

  • Consultmed SRL

    Iași, 700544, Romania

  • DM Clinical - Detroit

    Southfield, Michigan, 48076, United States

  • DM Clinical Research - Cyfair Clinical Research Center

    Houston, Texas, 77065, United States

  • DM Clinical Research - Martin Diagnostic Clinic

    Tomball, Texas, 77375, United States

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032, Hungary

  • Diabetes and Endocrinology Associates of Stark County Inc

    Canton, Ohio, 44718, United States

  • Diabetes and Glandular Disease Clinic

    San Antonio, Texas, 78229, United States

  • Drug Research Center Kft

    Balatonfüred, 8230, Hungary

  • Eastside Research Associates Health Research

    Redmond, Washington, 98052, United States

  • Florida Institute for Clinical Research

    Orlando, Florida, 32825, United States

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731, United States

  • Futuremeds spolka z ograniczona odpowiedzialnoscia

    Wroclaw, 53-673, Poland

  • General Hospital of Thessaloniki Ahepa

    Thessaloniki, 54636, Greece

  • Geniko Nosokomeio Peiraia Tzaneio

    Piraeus, 18536, Greece

  • Hope Clinical Research LLC

    Canoga Park, California, 91303, United States

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, Andalusia, 29010, Spain

  • Hospital Universitario Arnau de Vilanova Lleida

    Lleida, Catalonia, 25198, Spain

  • Hospital Universitario de La Ribera

    Alzira, Valencia, 46600, Spain

  • Hospital Vithas Sevilla

    Castilleja de la Cuesta, Andalusia, 41950, Spain

  • IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola

    Bologna, 40138, Italy

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • Institutul National de Diabet si Nutritie si Boli Metabolice N C Paulescu

    Bucharest, 030167, Romania

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Klinik Hietzing

    Vienna, 1130, Austria

  • Krankenhaus der Barmherzigen Brueder Linz

    Linz, 4021, Austria

  • Kunisaki Makoto Clinic

    Fukuoka, Fukuoka, 819-0168, Japan

  • Laiko General Hospital of Athens

    Athens, 11527, Greece

  • Latin Clinical Trial Center

    San Juan, 00909, Puerto Rico

  • Lausmed Kft

    Baja, 6500, Hungary

  • Manassas Clinical Research Center Inc

    Manassas, Virginia, 20110, United States

  • Mariodiab Clinic SRL

    Brasov, 500101, Romania

  • Medizinische Universitaet Graz

    Graz, 8036, Austria

  • Midori Clinic

    Nagasaki, Nagasaki, 852-8034, Japan

  • Montana Medical Research

    Missoula, Montana, 59808, United States

  • Morinaga Ueno Clinic

    Kumamoto, Kumamoto, 860-0863, Japan

  • Nakamoto Medical Clinic

    Mito, Ibaraki, 310-0826, Japan

  • National Cheng Kung University Hospital

    Tainan, 70403, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Nbr Polska Tomasz Klodawski

    Warsaw, 00-710, Poland

  • New Horizon Research Center

    Miami, Florida, 33165, United States

  • Northeast Research Institute - Neri

    Fleming Island, Florida, 32003, United States

  • Nowe Zdrowie-Ck Kieltucki i Wspolnicy Spolka Jawna

    Staszów, 28-200, Poland

  • Nzoz Specjalistyczny Osrodek Internistyczno-Diabetologiczny Malgorzata Arciszewska

    Bialystok, 15-435, Poland

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036, Hungary

  • Ohishi Naika Clinic

    Tsuchiura-shi, Ibaraki, 300-0835, Japan

  • Orange County Research Center

    Lake Forest, California, 92630, United States

  • Ostra Sjukhuset

    Gothenburg, 416 85, Sweden

  • Physicians East

    Greenville, North Carolina, 27834, United States

  • Plumeria DM Clinic

    Shizuoka, Shizuoka, 422-8006, Japan

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong, Hong Kong

  • Sabbatsbergs Sjukhus

    Stockholm, 113 61, Sweden

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

    Krakow, 30-688, Poland

  • San Jose Clinical Trials

    San Jose, California, 95128, United States

  • Seoul National University Bundang Hospital

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

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Shiraiwa Medical Clinic

    Kashiwara-shi, Osaka, 582-0005, Japan

  • Skanes universitetssjukhus

    Lund, 222 42, Sweden

  • Sodersjukhuset

    Stockholm, 118 83, Sweden

  • Southern Endocrinology Associates PA

    Mesquite, Texas, 75149, United States

  • Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft

    Budapest, 1036, Hungary

  • Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft

    Zalaegerszeg, 8900, Hungary

  • Szent Margit Rendelointezet Diabetologiai Ambulancia

    Budapest, 1032, Hungary

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tandem Clinical Research - Marrero

    Marrero, Louisiana, 70072, United States

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591, South Korea

  • Thermi Clinic S.A.

    Thessaloniki, 57001, Greece

  • Trial Management Associates - Myrtle Beach

    Myrtle Beach, South Carolina, 29572, United States

  • Universita degli Studi Gabriele D Annunzio di Chieti e Pescara

    Chieti, 66100, Italy

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Vienna, 1090, Austria

  • Universitetssjukhuset Orebro

    Örebro, 703 62, Sweden

  • Uniwersytecki Szpital Kliniczny numer 4 Centrum Innowacyjnych Terapii

    Lublin, 20-090, Poland

  • Velocity Clinical Research - Dallas

    Dallas, Texas, 75230, United States

  • Yutenji Medical Clinic

    Meguro-ku, Tokyo, 153-0053, Japan

More trials for these conditions

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