NCT07160257

A Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Function in Participants With Type 2 Diabetes Mellitus

A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Function in Participants With Type 2 Diabetes Mellitus

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the effect of maridebart cafraglutide relative to placebo on insulin sensitivity in participants with Type 2 Diabetes Mellitus (T2DM) treated with stable dose of metformin.

Conditions

• Type 2 Diabetes Mellitus

Interventions

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

Timeline

• Start date: 2025-08-05
• Primary completion: 2026-08-26
• Completion: 2026-12-13
• First posted: 2025-09-08
• Last updated: 2025-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study