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 | Active Not Recruiting Phase 1

• 2 other identifiers: BP459802025-521401-41-00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Type 2 Diabetes Mellitus; Overweight

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in M-value in a Hyperinsulinemic Euglycemic Glucose Clamp (HEC) at Week 24

  Baseline, Week 24

Secondary Outcomes (13)

• 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

Study Arms (2)

Placebo

EXPERIMENTAL

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

Drug: Placebo

RO7204239

EXPERIMENTAL

Participants will receive RO7204239, Q4W, as a SC injection for 24 weeks.

Drug: RO7204239

Interventions

Placebo DRUG

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

Placebo

RO7204239 DRUG

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

Also known as: GYM329

RO7204239

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung

Homburg, Saarland, 66421, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Overweight

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 13, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)