RecruitingPhase 1NCT07137585

A Study to Evaluate the Effect of RO7204239 on Insulin Sensitivity and Muscle Composition in Participants With Type 2 Diabetes Mellitus (T2DM) and Overweight or Obesity

Effects of RO7204239 on Insulin Sensitivity, Muscle Composition and Function in Participants Living With Type 2 Diabetes Mellitus and Overweight or Obesity: A Double-blind, Randomized, Placebo-controlled Study


Sponsor

Hoffmann-La Roche

Enrollment

30 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The main purpose of this study is to assess the effect of RO7204239 on insulin sensitivity versus placebo in participants with T2DM and obesity or overweight.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a new drug called RO7204239 can improve how well the body responds to insulin and help preserve muscle in people with type 2 diabetes who are overweight or obese. It aims to address both blood sugar control and muscle loss, which often occur together. **You may be eligible if...** - You have had type 2 diabetes for at least 6 months - You are managing it with diet/exercise alone, metformin, or certain other oral diabetes medications at a stable dose - Your HbA1c (a measure of blood sugar control over time) is between 6.5% and 10% - Your BMI is between 27 and 45 - Your weight has been stable for the past 3 months **You may NOT be eligible if...** - You have type 1 diabetes or a history of diabetic ketoacidosis - You take insulin or other injectable diabetes medications - You have significant heart, kidney, or liver disease - You are pregnant or planning to become pregnant - You have a history of certain cancers or muscle disorders 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.

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Interventions

DRUGPlacebo

RO7204239 matching placebo will be administered as per the schedule specified in the treatment arm.

DRUGRO7204239

RO7204239 will be administered as per the schedule specified in the treatment arm.


Locations(1)

Profil Institut für Stoffwechselforschung

Neuss, North Rhine-Westphalia, Germany

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NCT07137585


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