Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07137585

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung

Homburg, Saarland, 66421, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

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

RO7204239

Drug

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

Other names: GYM329

Primary outcomes

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

    Time frame: Baseline, Week 24

Secondary outcomes

  1. Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 and 24

    Time frame: Baseline, Week 12, Week 24

  2. Change From Baseline in Glucose Metabolism Assessed Using Fasting Glucose Test at Weeks 12 and 24

    Time frame: Baseline, Week 12, Week 24

  3. Change From Baseline in Glucose Metabolism Assessed Using Insulin Test at Weeks 12 and 24

    Time frame: Baseline, Week 12, Week 24

  4. Change From Baseline in Glucose Metabolism Assessed Using C-peptide Test at Weeks 12 and 24

    Time frame: Baseline, Week 12, Week 24

  5. Change From Baseline in Blood Lipid Profiles at Weeks 12 and 24

    Time frame: Baseline, Week 12, Week 24

  6. Change From Baseline in Body Weight at Weeks 12 and 24

    Time frame: Baseline, Week 12, Week 24

  7. Change From Baseline in Waist Circumference at Weeks 12 and 24

    Time frame: Baseline, Week 12, Week 24

  8. Change From Baseline in Waist to Height Ratio at Weeks 12 and 24

    Time frame: Baseline, Week 12, Week 24

  9. Change From Baseline in Total Lean Tissue Volume and Total Adipose Tissue Volume From Abdominal Magnetic Resonance Imaging (MRI) at Weeks 12 and 24

    Time frame: Baseline, Week 12, Week 24

  10. Change From Baseline in Muscle Volume From Thigh Muscle MRI at Weeks 12 and 24

    Time frame: Baseline, Week 12, Week 24

  11. Change From Baseline in Muscle Fat Infiltration From Thigh Muscle MRI at Weeks 12 and 24

    Time frame: Baseline, Week 12, Week 24

  12. Number of Participants With Adverse Events (AEs)

    Time frame: Up to Week 48

  13. Number of Participants With Local and Systemic Injection Reactions

    Time frame: Up to Week 48

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 22, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.