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Clinical Trials in Germany / NCT07137585
Active, not recruiting Phase 1

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

NCT07137585 · tracked via the Priya Life Science Germany tracker
Phase
Phase 1
Started
2025-09-30
Last updated
2026-09-29

Condition(s) studied

Type 2 Diabetes MellitusObesityOverweight

Investigational drug(s) / intervention(s)

PlaceboRO7204239 →

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participants with T2DM for at least 6 months, treated with diet, exercise and/or metformin alone or in combination with either dipeptidyl peptidase 4 (DPP-4) inhibitor or sodium-glucose co-transporter 2 (SGLT2) at stable dose for the last 3 months prior to study entry and with a HbA1c between ≤ 6.5% and ≤ 10% * Body mass index (BMI) within the range of 27.0 to 45.0 kilogram per meter square (kg/m2) * Stable body weight for the 3 months prior to screening * Participants on lipid-lowering or antihypertensive drugs must be on stable doses for at least 3 months Exclusion Criteria: * Type 1 diabetes mellitus (DM), known latent autoimmune diabetes in adults, or people with an episode of ketoacidosis or hyperosmolar state requiring hospitalisation in 6 months prior to screening * Active proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy requiring acute treatment * Uncontrolled comorbid conditions commonly associated with diabetes (for example, hypertension, hyperlipidaemia) * Severe hypoglycaemia within 6 months prior to screening visit * Current autonomic neuropathy as evidenced by neuropathic urinary retention, resting tachycardia, orthostatic hypotension, or diabetic diarrhea * Have evidence of a significant, uncontrolled endocrine abnormality (e.g., thyrotoxicosis and adrenal crises) * Are currently taking a central nervous system stimulant (e.g., Ritalin-SR), with the exception of caffeinated beverage * Have a known allergy, hypersensitivity, or intolerance to any component of the study treatment (i.e., RO7204239 / placebo) formulation * Blood donation of more than 500 milliliters (mL) within the past 3 months or blood transfusion or severe blood loss within 3 months prior to screening

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Profil Institut für Stoffwechselforschung Homburg Saarland

More Hoffmann-La Roche trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07137585 on ClinicalTrials.gov ↗ ← All trials in Germany