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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• Informed consent before initiation of any study-specific activities/procedures.

• Male or female participants aged ≥ 18 and ≤ 70 years at the time of signing informed consent.

• Body mass index 27 ≥ and ≤ 45 kg/m\^2 at screening.

• Diagnosis of T2DM at least 6 months before screening based on the WHO classification.

• Treatment of T2DM for at least 3 months prior to screening with diet and exercise and a stable dose of metformin (either immediate release or extended release), with or without a stable dose of 1 additional OAM other than metformin.

Locations
United States
California
ProSciento
RECRUITING
Chula Vista
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2025-08-05
Estimated Completion Date: 2026-12-13
Participants
Target number of participants: 70
Treatments
Experimental: Maridebart cafraglutide
Participants will receive maridebart cafraglutide subcutaneously (SC).
Placebo_comparator: Placebo
Participants will receive placebo SC.
Related Therapeutic Areas
Sponsors
Leads: Amgen

This content was sourced from clinicaltrials.gov