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Type 2 Diabetes Mellitus (T2DM)Phase 2NCT06660173

A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM)

A Phase 2 study testing Maridebart Cafraglutide in people with Type 2 Diabetes Mellitus (T2DM), run by Amgen at 96 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus (T2DM)
What is being tested?
Maridebart Cafraglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
409 participants
Where
96 sitesin 14 countries
Study dates
7 Nov 2024to 10 Nov 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

96 sites in 14 countries.

96 sites in 14 countries

United States28 sites

  • Anaheim Clinical Trials

    Anaheim, California, 92801

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • Accel Research Site - Birmingham Clinical Research Unit

    Birmingham, Alabama, 35216

  • Hope Clinical Research LLC

    Canoga Park, California, 91303

  • Diabetes and Endocrinology Associates of Stark County Inc

    Canton, Ohio, 44718

  • Charlottesville Medical Research Center

    Charlottesville, Virginia, 22911

  • Cedar Crosse Research and Health Care

    Chicago, Illinois, 60607

  • Velocity Clinical Research - Dallas

    Dallas, Texas, 75230

  • Accel Research Site - Neurostudies

    Decatur, Georgia, 30030

  • Northeast Research Institute - Neri

    Fleming Island, Florida, 32003

  • Physicians East

    Greenville, North Carolina, 27834

  • DM Clinical Research - Cyfair Clinical Research Center

    Houston, Texas, 77065

  • Orange County Research Center

    Lake Forest, California, 92630

  • Manassas Clinical Research Center Inc

    Manassas, Virginia, 20110

  • Tandem Clinical Research - Marrero

    Marrero, Louisiana, 70072

  • Southern Endocrinology Associates PA

    Mesquite, Texas, 75149

  • New Horizon Research Center

    Miami, Florida, 33165

  • Montana Medical Research

    Missoula, Montana, 59808

  • Trial Management Associates - Myrtle Beach

    Myrtle Beach, South Carolina, 29572

  • Alliance for Multispecialty Research

    Norman, Oklahoma, 73069

  • Florida Institute for Clinical Research

    Orlando, Florida, 32825

  • Eastside Research Associates Health Research

    Redmond, Washington, 98052

  • Be Well Clinical Studies

    Round Rock, Texas, 78681

  • Diabetes and Glandular Disease Clinic

    San Antonio, Texas, 78229

  • San Jose Clinical Trials

    San Jose, California, 95128

  • DM Clinical - Detroit

    Southfield, Michigan, 48076

  • DM Clinical Research - Martin Diagnostic Clinic

    Tomball, Texas, 77375

  • Conquest Research - Winter Park

    Winter Park, Florida, 32789

Other trials in United States

Hungary10 sites

  • Lausmed Kft

    Baja, 6500

  • Drug Research Center Kft

    Balatonfüred, 8230

  • Szent Margit Rendelointezet Diabetologiai Ambulancia

    Budapest, 1032

  • Clinexpert Kft

    Budapest, 1033

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036

  • Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft

    Budapest, 1036

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • CRU Hungary Kft

    Encs, 3860

  • Borbanya Praxis Egeszsegugyi Kft

    Nyíregyháza, 4405

  • Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft

    Zalaegerszeg, 8900

Other trials in Hungary

Japan8 sites

  • Kunisaki Makoto Clinic

    Fukuoka, Fukuoka, 819-0168

  • Shiraiwa Medical Clinic

    Kashiwara-shi, Osaka, 582-0005

  • Morinaga Ueno Clinic

    Kumamoto, Kumamoto, 860-0863

  • Yutenji Medical Clinic

    Meguro-ku, Tokyo, 153-0053

  • Nakamoto Medical Clinic

    Mito, Ibaraki, 310-0826

  • Midori Clinic

    Nagasaki, Nagasaki, 852-8034

  • Plumeria DM Clinic

    Shizuoka, Shizuoka, 422-8006

  • Ohishi Naika Clinic

    Tsuchiura-shi, Ibaraki, 300-0835

Other trials in Japan

Poland7 sites

  • Nzoz Specjalistyczny Osrodek Internistyczno-Diabetologiczny Malgorzata Arciszewska

    Bialystok, 15-435

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

    Krakow, 30-688

  • Uniwersytecki Szpital Kliniczny numer 4 Centrum Innowacyjnych Terapii

    Lublin, 20-090

  • Nowe Zdrowie-Ck Kieltucki i Wspolnicy Spolka Jawna

    Staszów, 28-200

  • Nbr Polska Tomasz Klodawski

    Warsaw, 00-710

  • Centrum Badan Klinicznych Piotr Napora lekarze spolka partnerska

    Wroclaw, 51-162

  • Futuremeds spolka z ograniczona odpowiedzialnoscia

    Wroclaw, 53-673

Other trials in Poland

Greece6 sites

  • Laiko General Hospital of Athens

    Athens, 11527

  • Athens Medical Center S.A - Iatriko Amarousiou

    Marousi, 15125

  • Athens Medical Center- Iatriko Paleou Falirou

    Palaió Fáliro, 17562

  • Geniko Nosokomeio Peiraia Tzaneio

    Piraeus, 18536

  • General Hospital of Thessaloniki Ahepa

    Thessaloniki, 54636

  • Thermi Clinic S.A.

    Thessaloniki, 57001

Other trials in Greece

Italy6 sites

  • Azienda Universitaria Ospedaliera Consorziale Policlinico Bari

    Bari, 70124

  • IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola

    Bologna, 40138

  • Universita degli Studi Gabriele D Annunzio di Chieti e Pescara

    Chieti, 66100

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco

    Milan, 20157

Other trials in Italy

South Korea6 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

Other trials in South Korea

Romania5 sites

  • Mariodiab Clinic SRL

    Brasov, 500101

  • Centrul pentru Studiul Metabolismului - Hightech Medical Services SRL

    Bucharest, 011052

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

    Bucharest, 030167

  • Consultmed SRL

    Iași, 700544

  • Clinica Korall

    Satu Mare, 440055

Other trials in Romania

Spain5 sites

  • Complexo Hospitalario Universitario A Coruña

    A Coruña, Galicia, 15006

  • Hospital Universitario de La Ribera

    Alzira, Valencia, 46600

  • Hospital Vithas Sevilla

    Castilleja de la Cuesta, Andalusia, 41950

  • Hospital Universitario Arnau de Vilanova Lleida

    Lleida, Catalonia, 25198

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, Andalusia, 29010

Other trials in Spain

Sweden5 sites

  • Ostra Sjukhuset

    Gothenburg, 416 85

  • Skanes universitetssjukhus

    Lund, 222 42

  • Universitetssjukhuset Orebro

    Örebro, 703 62

  • Sabbatsbergs Sjukhus

    Stockholm, 113 61

  • Sodersjukhuset

    Stockholm, 118 83

Other trials in Sweden

Austria4 sites

  • Medizinische Universitaet Graz

    Graz, 8036

  • Krankenhaus der Barmherzigen Brueder Linz

    Linz, 4021

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Vienna, 1090

  • Klinik Hietzing

    Vienna, 1130

Other trials in Austria

Taiwan4 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Hong Kong1 site

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

Puerto Rico1 site

  • Latin Clinical Trial Center

    San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: A Study to Evaluate the Efficacy, Safety & Tolerability of Maridebart Cafraglutide in Adults With T2DM

The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.

Being tested
Maridebart Cafraglutide, Placebo
Keywords
Obesity, AMG 133, T2DM, Hemoglobin A1C (HbA1c)
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maridebart CafraglutideDrug

    Also called AMG 133

    Solution for subcutaneous injection.

  • PlaceboDrug

    Solution for subcutaneous injection.

Study groups in NCT06660173
Study groupRoleWhat they receive
Maridebart CafraglutideExperimentalParticipants 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.
Receives: Drug: Maridebart Cafraglutide
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)

    Measured: Baseline to Week 24

Secondary outcomes (21)

  1. Percent Change From Baseline to Week 24 in Body Weight

    Measured: Baseline to Week 24

  2. Number of Participants Achieving HbA1c < 7.0% at Week 24

    Measured: Week 24

  3. Number of Participants Achieving HbA1c ≤ 6.5% at Week 24

    Measured: Week 24

  4. Number of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 24

    Measured: Week 24

  5. Number of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 24

    Measured: Week 24

  6. Change From Baseline to Week 24 in Fasting Glucose

    Measured: Baseline to Week 24

  7. Percent Change From Baseline to Week 24 in Total Cholesterol

    Measured: Baseline to Week 24

  8. Percent Change From Baseline to Week 24 in Low-density Lipoprotein Cholesterol (LDL-C)

    Measured: Baseline to Week 24

  9. Percent Change From Baseline to Week 24 in High-density Lipoprotein Cholesterol (HDL-C)

    Measured: Baseline to Week 24

  10. Percent Change From Baseline to Week 24 in Non-high Density Lipoprotein Cholesterol (non-HDL-C)

    Measured: Baseline to Week 24

  11. Percent Change From Baseline to Week 24 in Very-low-density Lipoprotein Cholesterol (VLDL-C)

    Measured: Baseline to Week 24

  12. Percent Change From Baseline to Week 24 in Triglycerides

    Measured: Baseline to Week 24

  13. Percent Change From Baseline to Week 24 in Free Fatty Acids (FFA)

    Measured: Baseline and Week 24

  14. Change From Baseline to Week 24 in Systolic Blood Pressure

    Measured: Baseline and Week 24

  15. Change From Baseline to Week 24 in Diastolic Blood Pressure

    Measured: Baseline and Week 24

  16. Change from Baseline to Week 24 in High-sensitivity C-reactive Protein

    Measured: Baseline and Week 24

  17. Pre-dose Plasma Concentration of Maridebart Cafraglutide at Week 20

    Measured: Week 20

  18. Maximum Observed Plasma Concentration of Maridebart Cafraglutide at Week 20

    Measured: Week 20

  19. Number of Participants with Treatment Emergent Adverse Events

    Measured: Up to 24 Weeks

  20. Number of Participants with Serious Adverse Events

    Measured: Up to 24 Weeks

  21. Number of Participants with Anti-maridebart Cafraglutide Antibody Formation

    Measured: Up to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2024
  2. Study start7 Nov 2024
  3. Primary completion6 Oct 2025
  4. Study completion10 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
409 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06660173
Sponsor's protocol ID
20230143
Other IDs
2024-513539-25-00
Status last verified
Sep 2026
First submitted
18 Oct 2024
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Maridebart Cafraglutide in people with Type 2 Diabetes Mellitus (T2DM), run by Amgen at 96 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States, Hungary, Japan, Poland, Greece and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06660173.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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