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New drug aims to boost insulin sensitivity and muscle health in diabetes

NCT ID NCT07137585

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This early-stage trial tests whether a drug called RO7204239 can improve how the body uses insulin and affects muscle composition in 30 adults with type 2 diabetes who are overweight or obese. Participants will receive either the drug or a placebo, and researchers will measure changes in insulin sensitivity and blood sugar control over 24 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RO7204239 (also called GYM329)
What this could lead to
If it works, this could point toward a new treatment that helps control blood sugar and improve muscle function in people with type 2 diabetes.
What could go wrong
This is a very early Phase 1 trial with only 30 participants, so results may not apply to everyone. The drug may not improve insulin sensitivity or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity Overweight Type 2 diabetes mellitus

Contacts and locations

Locations

  • Profil Institut für Stoffwechselforschung

    Homburg, Saarland, 66421, Germany

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