A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM)
NCT ID: NCT06660173
Last Updated: 2025-11-25
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
409 participants
INTERVENTIONAL
2024-11-07
2026-11-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Tolerability, and Efficacy Study of MB07803 Administered to Patients With Type 2 Diabetes Mellitus
NCT00458016
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002)
NCT01640873
Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes
NCT02057172
A Study to Evaluate Safety and Efficacy of TTP273 for 12 Weeks in Subjects With Type 2 Diabetes
NCT02653599
A Study to Assess the Safety and Efficacy of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control (MK-3102-011)
NCT01717313
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Maridebart Cafraglutide
Participants will be randomized to receive maridebart cafraglutide at varying dose levels, or placebo, for up to 24 weeks. Participants who complete the 24-week Part 1 treatment period and meet specific criteria will have the option to begin an exploratory part 2 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks. Participants who complete the 24-week Part 2 treatment period and meet specific criteria will have the option to begin an exploratory part 3 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks.
Maridebart Cafraglutide
Solution for subcutaneous injection.
Placebo
Participants will be randomized to receive maridebart cafraglutide at varying dose levels, or placebo, for up to 24 weeks. Participants who complete the 24-week Part 1 treatment period and meet specific criteria will have the option to begin an exploratory part 2 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks. Participants who complete the 24-week Part 2 treatment period and meet specific criteria will have the option to begin an exploratory part 3 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks.
Placebo
Solution for subcutaneous injection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Maridebart Cafraglutide
Solution for subcutaneous injection.
Placebo
Solution for subcutaneous injection.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MD
Role: STUDY_DIRECTOR
Amgen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Accel Research Site - Birmingham Clinical Research Unit
Birmingham, Alabama, United States
Anaheim Clinical Trials
Anaheim, California, United States
Hope Clinical Research LLC
Canoga Park, California, United States
Orange County Research Center
Lake Forest, California, United States
San Jose Clinical Trials
San Jose, California, United States
Northeast Research Institute - Neri
Fleming Island, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Florida Institute for Clinical Research
Orlando, Florida, United States
Conquest Research - Winter Park
Winter Park, Florida, United States
Accel Research Site - Neurostudies
Decatur, Georgia, United States
Cedar Crosse Research and Health Care
Chicago, Illinois, United States
Tandem Clinical Research - Marrero
Marrero, Louisiana, United States
DM Clinical - Detroit
Southfield, Michigan, United States
Montana Medical Research
Missoula, Montana, United States
Physicians East
Greenville, North Carolina, United States
Diabetes and Endocrinology Associates of Stark County Inc
Canton, Ohio, United States
Alliance for Multispecialty Research
Norman, Oklahoma, United States
Trial Management Associates - Myrtle Beach
Myrtle Beach, South Carolina, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Velocity Clinical Research - Dallas
Dallas, Texas, United States
DM Clinical Research - Cyfair Clinical Research Center
Houston, Texas, United States
Southern Endocrinology Associates PA
Mesquite, Texas, United States
Be Well Clinical Studies
Round Rock, Texas, United States
Diabetes and Glandular Disease Clinic
San Antonio, Texas, United States
DM Clinical Research - Martin Diagnostic Clinic
Tomball, Texas, United States
Charlottesville Medical Research Center
Charlottesville, Virginia, United States
Manassas Clinical Research Center Inc
Manassas, Virginia, United States
Eastside Research Associates Health Research
Redmond, Washington, United States
Medizinische Universitaet Graz
Graz, , Austria
Krankenhaus der Barmherzigen Brueder Linz
Linz, , Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, , Austria
Klinik Hietzing
Vienna, , Austria
Laiko General Hospital of Athens
Athens, , Greece
Athens Medical Center S.A - Iatriko Amarousiou
Marousi, , Greece
Athens Medical Center- Iatriko Paleou Falirou
Palaió Fáliro, , Greece
Geniko Nosokomeio Peiraia Tzaneio
Piraeus, , Greece
General Hospital of Thessaloniki Ahepa
Thessaloniki, , Greece
Thermi Clinic S.A.
Thessaloniki, , Greece
Queen Mary Hospital, The University of Hong Kong
Hong Kong, , Hong Kong
Lausmed Kft
Baja, , Hungary
Drug Research Center Kft
Balatonfüred, , Hungary
Szent Margit Rendelointezet Diabetologiai Ambulancia
Budapest, , Hungary
Clinexpert Kft
Budapest, , Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest, , Hungary
Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
CRU Hungary Kft
Encs, , Hungary
Borbanya Praxis Egeszsegugyi Kft
Nyíregyháza, , Hungary
Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft
Zalaegerszeg, , Hungary
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Bari, , Italy
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola
Bologna, , Italy
Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
Chieti, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco
Milan, , Italy
Kunisaki Makoto Clinic
Fukuoka, Fukuoka, Japan
Nakamoto Medical Clinic
Mito, Ibaraki, Japan
Ohishi Naika Clinic
Tsuchiura-shi, Ibaraki, Japan
Morinaga Ueno Clinic
Kumamoto, Kumamoto, Japan
Midori Clinic
Nagasaki, Nagasaki, Japan
Shiraiwa Medical Clinic
Kashiwara-shi, Osaka, Japan
Plumeria DM Clinic
Shizuoka, Shizuoka, Japan
Yutenji Medical Clinic
Meguro-ku, Tokyo, Japan
Nzoz Specjalistyczny Osrodek Internistyczno-Diabetologiczny Malgorzata Arciszewska
Bialystok, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Uniwersytecki Szpital Kliniczny numer 4 Centrum Innowacyjnych Terapii
Lublin, , Poland
Nowe Zdrowie-Ck Kieltucki i Wspolnicy Spolka Jawna
Staszów, , Poland
Nbr Polska Tomasz Klodawski
Warsaw, , Poland
Centrum Badan Klinicznych Piotr Napora lekarze spolka partnerska
Wroclaw, , Poland
Futuremeds spolka z ograniczona odpowiedzialnoscia
Wroclaw, , Poland
Latin Clinical Trial Center
San Juan, , Puerto Rico
Mariodiab Clinic SRL
Brasov, , Romania
Centrul pentru Studiul Metabolismului - Hightech Medical Services SRL
Bucharest, , Romania
Institutul National de Diabet si Nutritie si Boli Metabolice N C Paulescu
Bucharest, , Romania
Consultmed SRL
Iași, , Romania
Clinica Korall
Satu Mare, , Romania
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
The Catholic University of Korea Seoul St Marys 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
Hospital Universitario de La Ribera
Alzira, Valencia, Spain
Ostra Sjukhuset
Gothenburg, , Sweden
Skanes universitetssjukhus
Lund, , Sweden
Universitetssjukhuset Orebro
Örebro, , Sweden
Sabbatsbergs Sjukhus
Stockholm, , Sweden
Sodersjukhuset
Stockholm, , Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
AmgenTrials clinical trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-513539-25-00
Identifier Type: CTIS
Identifier Source: secondary_id
20230143
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.