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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus (T2DM)

In brief

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

Key facts

Study ID

NCT06660173

Run by

Amgen

People needed

409

Starts

2024-11-07

Expected to finish

2026-11-10

Last updated by the study team

2025-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• Accel Research Site - Birmingham Clinical Research Unit — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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