RecruitingPhase 1NCT07160257

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


Sponsor

Amgen

Enrollment

70 participants

Start Date

Aug 5, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether maridebart cafraglutide — a new medication that combines GLP-1 and GIP hormone activity (similar to drugs like tirzepatide) — can improve insulin sensitivity and the functioning of insulin-producing cells (beta cells) in people with Type 2 diabetes. **You may be eligible if...** - You are between 18 and 70 years old - You have a BMI between 27 and 45 kg/m² - You have had Type 2 diabetes for at least 6 months - You are managing your diabetes with diet, exercise, and a stable dose of metformin (with or without one other diabetes medication) **You may NOT be eligible if...** - You have Type 1 diabetes or a history of diabetic ketoacidosis - You have had a severe hypoglycemic episode (requiring someone else's help) in the past 6 months - You have diabetic eye disease requiring urgent treatment - You have a history of pancreatitis or thyroid cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMaridebart cafraglutide

Maridebart cafraglutide will be administered SC.

DRUGPlacebo

Placebo will be administered SC.


Locations(1)

ProSciento, Inc. - Main Clinic

Chula Vista, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07160257


Related Trials