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

NCT06660173 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 202301432024-513539-25-00
• Study Type: interventional
• Target: 409
• Locations: 14 countries
• Sites: 96

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Obesity; AMG 133; T2DM; Hemoglobin A1C (HbA1c)

Outcome Measures

Primary Outcomes (1)

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

  Baseline to Week 24

Secondary Outcomes (21)

• Percent Change From Baseline to Week 24 in Body Weight

  Baseline to Week 24

• Number of Participants Achieving HbA1c < 7.0% at Week 24

  Week 24

• Number of Participants Achieving HbA1c ≤ 6.5% at Week 24

  Week 24

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

  Week 24

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

  Week 24

Study Arms (2)

Maridebart Cafraglutide

EXPERIMENTAL

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.

Drug: Maridebart Cafraglutide

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Maridebart Cafraglutide DRUG

Solution for subcutaneous injection.

Also known as: AMG 133

Maridebart Cafraglutide

Placebo DRUG

Solution for subcutaneous injection.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (96)

Accel Research Site - Birmingham Clinical Research Unit

Birmingham, Alabama, 35216, United States

Location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Hope Clinical Research LLC

Canoga Park, California, 91303, United States

Location

Orange County Research Center

Lake Forest, California, 92630, United States

Location

San Jose Clinical Trials

San Jose, California, 95128, United States

Location

Northeast Research Institute - Neri

Fleming Island, Florida, 32003, United States

Location

New Horizon Research Center

Miami, Florida, 33165, United States

Location

Florida Institute for Clinical Research

Orlando, Florida, 32825, United States

Location

Conquest Research - Winter Park

Winter Park, Florida, 32789, United States

Location

Accel Research Site - Neurostudies

Decatur, Georgia, 30030, United States

Location

Cedar Crosse Research and Health Care

Chicago, Illinois, 60607, United States

Location

Tandem Clinical Research - Marrero

Marrero, Louisiana, 70072, United States

Location

DM Clinical - Detroit

Southfield, Michigan, 48076, United States

Location

Montana Medical Research

Missoula, Montana, 59808, United States

Location

Physicians East

Greenville, North Carolina, 27834, United States

Location

Diabetes and Endocrinology Associates of Stark County Inc

Canton, Ohio, 44718, United States

Location

Alliance for Multispecialty Research

Norman, Oklahoma, 73069, United States

Location

Trial Management Associates - Myrtle Beach

Myrtle Beach, South Carolina, 29572, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

Velocity Clinical Research - Dallas

Dallas, Texas, 75230, United States

Location

DM Clinical Research - Cyfair Clinical Research Center

Houston, Texas, 77065, United States

Location

Southern Endocrinology Associates PA

Mesquite, Texas, 75149, United States

Location

Be Well Clinical Studies

Round Rock, Texas, 78681, United States

Location

Diabetes and Glandular Disease Clinic

San Antonio, Texas, 78229, United States

Location

DM Clinical Research - Martin Diagnostic Clinic

Tomball, Texas, 77375, United States

Location

Charlottesville Medical Research Center

Charlottesville, Virginia, 22911, United States

Location

Manassas Clinical Research Center Inc

Manassas, Virginia, 20110, United States

Location

Eastside Research Associates Health Research

Redmond, Washington, 98052, United States

Location

Medizinische Universitaet Graz

Graz, 8036, Austria

Location

Krankenhaus der Barmherzigen Brueder Linz

Linz, 4021, Austria

Location

Universitaetsklinikum Allgemeines Krankenhaus Wien

Vienna, 1090, Austria

Location

Klinik Hietzing

Vienna, 1130, Austria

Location

Laiko General Hospital of Athens

Athens, 11527, Greece

Location

Athens Medical Center S.A - Iatriko Amarousiou

Marousi, 15125, Greece

Location

Athens Medical Center- Iatriko Paleou Falirou

Palaió Fáliro, 17562, Greece

Location

Geniko Nosokomeio Peiraia Tzaneio

Piraeus, 18536, Greece

Location

General Hospital of Thessaloniki Ahepa

Thessaloniki, 54636, Greece

Location

Thermi Clinic S.A.

Thessaloniki, 57001, Greece

Location

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Location

Lausmed Kft

Baja, 6500, Hungary

Location

Drug Research Center Kft

Balatonfüred, 8230, Hungary

Location

Szent Margit Rendelointezet Diabetologiai Ambulancia

Budapest, 1032, Hungary

Location

Clinexpert Kft

Budapest, 1033, Hungary

Location

Obudai Egeszsegugyi Centrum Kft

Budapest, 1036, Hungary

Location

Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft

Budapest, 1036, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

CRU Hungary Kft

Encs, 3860, Hungary

Location

Borbanya Praxis Egeszsegugyi Kft

Nyíregyháza, 4405, Hungary

Location

Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft

Zalaegerszeg, 8900, Hungary

Location

Azienda Universitaria Ospedaliera Consorziale Policlinico Bari

Bari, 70124, Italy

Location

IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola

Bologna, 40138, Italy

Location

Universita degli Studi Gabriele D Annunzio di Chieti e Pescara

Chieti, 66100, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco

Milan, 20157, Italy

Location

Kunisaki Makoto Clinic

Fukuoka, Fukuoka, 819-0168, Japan

Location

Nakamoto Medical Clinic

Mito, Ibaraki, 310-0826, Japan

Location

Ohishi Naika Clinic

Tsuchiura-shi, Ibaraki, 300-0835, Japan

Location

Morinaga Ueno Clinic

Kumamoto, Kumamoto, 860-0863, Japan

Location

Midori Clinic

Nagasaki, Nagasaki, 852-8034, Japan

Location

Shiraiwa Medical Clinic

Kashiwara-shi, Osaka, 582-0005, Japan

Location

Plumeria DM Clinic

Shizuoka, Shizuoka, 422-8006, Japan

Location

Yutenji Medical Clinic

Meguro-ku, Tokyo, 153-0053, Japan

Location

Nzoz Specjalistyczny Osrodek Internistyczno-Diabetologiczny Malgorzata Arciszewska

Bialystok, 15-435, Poland

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

Location

Uniwersytecki Szpital Kliniczny numer 4 Centrum Innowacyjnych Terapii

Lublin, 20-090, Poland

Location

Nowe Zdrowie-Ck Kieltucki i Wspolnicy Spolka Jawna

Staszów, 28-200, Poland

Location

Nbr Polska Tomasz Klodawski

Warsaw, 00-710, Poland

Location

Centrum Badan Klinicznych Piotr Napora lekarze spolka partnerska

Wroclaw, 51-162, Poland

Location

Futuremeds spolka z ograniczona odpowiedzialnoscia

Wroclaw, 53-673, Poland

Location

Latin Clinical Trial Center

San Juan, 00909, Puerto Rico

Location

Mariodiab Clinic SRL

Brasov, 500101, Romania

Location

Centrul pentru Studiul Metabolismului - Hightech Medical Services SRL

Bucharest, 011052, Romania

Location

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

Bucharest, 030167, Romania

Location

Consultmed SRL

Iași, 700544, Romania

Location

Clinica Korall

Satu Mare, 440055, Romania

Location

Seoul National University Bundang Hospital

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

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591, South Korea

Location

Hospital Vithas Sevilla

Castilleja de la Cuesta, Andalusia, 41950, Spain

Location

Hospital Clinico Universitario Virgen de la Victoria

Málaga, Andalusia, 29010, Spain

Location

Hospital Universitario Arnau de Vilanova Lleida

Lleida, Catalonia, 25198, Spain

Location

Complexo Hospitalario Universitario A Coruña

A Coruña, Galicia, 15006, Spain

Location

Hospital Universitario de La Ribera

Alzira, Valencia, 46600, Spain

Location

Ostra Sjukhuset

Gothenburg, 416 85, Sweden

Location

Skanes universitetssjukhus

Lund, 222 42, Sweden

Location

Universitetssjukhuset Orebro

Örebro, 703 62, Sweden

Location

Sabbatsbergs Sjukhus

Stockholm, 113 61, Sweden

Location

Sodersjukhuset

Stockholm, 118 83, Sweden

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 28, 2024
• Study Start: November 7, 2024
• Primary Completion: October 6, 2025
• Study Completion (Estimated): November 10, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

SE (5); TW (4); JP (8); AU (4); IT (6); HK (1); PR (1); US (28); PL (7); HU (10); RO (5); GR (6); KR (6); ES (5)