NCT06858878

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

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,105 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

Interventions

Type	Name	Description
DRUG	Maridebart cafraglutide	Maridebart cafraglutide will be adminstered SC.
DRUG	Placebo	Placebo will be adminstered SC.

Timeline

• Start date: 2025-03-17
• Primary completion: 2027-01-21
• Completion: 2027-04-16
• First posted: 2025-03-05
• Last updated: 2025-12-31

Locations

187 sites across 13 countries: United States, Argentina, Bulgaria, Canada, Czechia, Germany, Hungary, Italy, Japan, Poland, Puerto Rico, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study