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

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes Mellitus; Obesity; Overweight
• Interventions: Drug: Placebo; Drug: RO7204239

• Registration Number: NCT07137585
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-14
• Study First Submitted: 2025-08-15
• Study First Submitted QC: 2025-08-15
• Last Update Submitted: 2025-08-15
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive RO7204239 matching placebo, every 4 weeks (Q4W), as a subcutaneous (SC) injection for 24 weeks.
RO7204239	RO7204239	Participants will receive RO7204239, Q4W, as a SC injection for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in M-value in a Hyperinsulinemic Euglycemic Glucose Clamp (HEC) at Week 24	Baseline, Week 24

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 and 24	Baseline, Week 12, Week 24
Change From Baseline in Glucose Metabolism Assessed Using Fasting Glucose Test at Weeks 12 and 24	Baseline, Week 12, Week 24
Change From Baseline in Glucose Metabolism Assessed Using Insulin Test at Weeks 12 and 24	Baseline, Week 12, Week 24
Change From Baseline in Glucose Metabolism Assessed Using C-peptide Test at Weeks 12 and 24	Baseline, Week 12, Week 24
Change From Baseline in Blood Lipid Profiles at Weeks 12 and 24	Baseline, Week 12, Week 24
Change From Baseline in Body Weight at Weeks 12 and 24	Baseline, Week 12, Week 24
Change From Baseline in Waist Circumference at Weeks 12 and 24	Baseline, Week 12, Week 24
Change From Baseline in Waist to Height Ratio at Weeks 12 and 24	Baseline, Week 12, Week 24
Change From Baseline in Total Lean Tissue Volume and Total Adipose Tissue Volume From Abdominal Magnetic Resonance Imaging (MRI) at Weeks 12 and 24	Baseline, Week 12, Week 24
Change From Baseline in Muscle Volume From Thigh Muscle MRI at Weeks 12 and 24	Baseline, Week 12, Week 24
Change From Baseline in Muscle Fat Infiltration From Thigh Muscle MRI at Weeks 12 and 24	Baseline, Week 12, Week 24
Number of Participants With Adverse Events (AEs)	Up to Week 48
Number of Participants With Local and Systemic Injection Reactions	Up to Week 48