Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

In brief

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.

Key facts

Study ID

NCT06858878

Run by

Amgen

People needed

1105

Starts

2025-03-17

Expected to finish

2027-04-16

Last updated by the study team

2025-12-31

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years.
• Body mass index ≥ 27 kg/m\^2.
• History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
• Diagnosis of T2DM.

You may not qualify if…

• Type 1 diabetes mellitus.
• Self-reported change in body weight > 5 kg within 90 days before screening.
• Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment.
• Obesity induced by other endocrinologic disorders.
• Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
• History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
• History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
• Lifetime history of suicide attempt.

Where it is running

• Gilbert Center for Family Medicine — Gilbert, Arizona, United States
• Desert Clinical Research — Mesa, Arizona, United States
• Avacare Foothills Research Center — Phoenix, Arizona, United States
• San Fernando Valley Health Institute — Canoga Park, California, United States
• Core Healthcare Group — Cerritos, California, United States
• Velocity Clinical Research Chula Vista — Chula Vista, California, United States
• Headlands Research California — Escondido, California, United States
• Paradigm Clinical Research — Modesto, California, United States
• Flourish Research — Northridge, California, United States
• University of California Irvine — Orange, California, United States
• Empire Clinical Research — Pomona, California, United States
• Infinity Clinical Trials — San Diego, California, United States
• Greenwich Clinical Trials — Riverside, Connecticut, United States
• Indago Research and Health Center — Hialeah, Florida, United States
• Optimus U Corporation — Miami, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• San Marcus Research Clinic Inc — Miami Lakes, Florida, United States
• Florida Institute for Clinical Research — Orlando, Florida, United States
• Encore Medical Research of Weston LLC — Weston, Florida, United States
• Conquest Research - Winter Park — Winter Park, Florida, United States
• Alliance For Multispecialty Research - Oak Brook — Oak Brook, Illinois, United States
• Alliance for Multispecialty Research, LLC - Park Ridge — Park Ridge, Illinois, United States
• Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie — Skokie, Illinois, United States
• Indiana Medical Research Institute — Merrillville, Indiana, United States
• Alliance for Multispecialty Research Mobile — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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