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

Launched by HOFFMANN-LA ROCHE · Aug 15, 2025

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ClinConnect Summary

This clinical trial is studying a new medicine called RO7204239 to see if it can help improve how the body uses insulin, a hormone that controls blood sugar, in people who have type 2 diabetes and are overweight or obese. The study will compare this medicine to a placebo, which is a harmless pill with no active medicine, to understand if RO7204239 works better. It is an early-phase trial, meaning researchers are mainly checking if the medicine is safe and how it affects the body.

People who might be eligible to join are adults aged 65 to 74 who have had type 2 diabetes for at least six months and are managing it with diet, exercise, and certain diabetes medicines like metformin. They also need to have a body weight that fits within a specific range (a body mass index between 27 and 45) and have stable weight and medication doses for a few months before joining. Participants should not have serious diabetes complications or other major health problems. If you join, you can expect to take either the new medicine or a placebo while doctors monitor your insulin sensitivity and muscle health to see if the treatment makes a difference. The study is not yet recruiting, so if you or a family member fit these criteria and are interested, you may want to keep an eye out for when it opens.

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Eligibility criteria

• 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