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
Inclusion Criteria4
- 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 Criteria9
- 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
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07137585
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