Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

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

Conditions studied: Obesity

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

NCT06858839

Run by

Amgen

People needed

3853

Starts

2025-03-12

Expected to finish

2027-04-16

Last updated by the study team

2025-10-20

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 ≥ 30 kg/m2 or ≥27 kg/m² to < 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH).
• History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.

You may not qualify if…

• Type 1 or Typ2 diabetes mellitus.
• Obesity induced by other endocrinologic disorders.
• Self-reported change in body weight > 5 kg within 90 days before screening.
• 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

• Alliance For Multispecialty Research - Daphne — Daphne, Alabama, United States
• Alliance for Multispecialty Research Mobile — Mobile, Alabama, United States
• Avacare Foothills Research Center — Phoenix, Arizona, United States
• Ark Clinical Research- Tustin — Fountain Valley, California, United States
• Long Beach Clinical Trials Services Inc — Long Beach, California, United States
• Ark Clinical Research- Long Beach — Long Beach, California, United States
• Catalina Research Institute — Montclair, California, United States
• Artemis Institute for Clinical Research — Riverside, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Apex Clinical Research — San Diego, California, United States
• Southern California Clinical Research — Santa Ana, California, United States
• Diablo Clinical Research — Walnut Creek, California, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Chase Medical Research LLC — Waterbury, Connecticut, United States
• Indago Research and Health Center — Hialeah, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Clinical Neuroscience Solutions - Jacksonville — Jacksonville, Florida, United States
• South Florida Wellness and Clinical Research Institute — Margate, Florida, United States
• Optimus U Corporation — Miami, Florida, United States
• Research Institute of South Florida — Miami, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Clinical Neuroscience Solutions - Orlando — Orlando, Florida, United States
• Combined Research Orlando Phase I IV — Orlando, Florida, United States
• Florida Institute for Clinical Research — Orlando, Florida, United States
• Pinnacle Research Group LLC — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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