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Type 2 Diabetes MellitusPhase 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

A Phase 1 study testing RO7204239 in people with Type 2 Diabetes Mellitus and Obesity, run by Hoffmann-La Roche at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus, Obesity, Overweight
What is being tested?
RO7204239
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteGermany
Study dates
30 Sep 2025to 28 Feb 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Profil Institut für Stoffwechselforschung

    Homburg, Saarland, 66421

Other trials in Germany

About this study

Official 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

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.

Being tested
Placebo, RO7204239
Medical subject headings
Diabetes Mellitus, Type 2, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

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

  • RO7204239Drug

    Also called GYM329

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

Study groups in NCT07137585
Study groupRoleWhat they receive
PlaceboExperimentalParticipants will receive RO7204239 matching placebo, every 4 weeks (Q4W), as a subcutaneous (SC) injection for 24 weeks.
Receives: Drug: Placebo
RO7204239ExperimentalParticipants will receive RO7204239, Q4W, as a SC injection for 24 weeks.
Receives: Drug: RO7204239

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline, Week 24

Secondary outcomes (13)

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

    Measured: Baseline, Week 12, Week 24

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

    Measured: Baseline, Week 12, Week 24

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

    Measured: Baseline, Week 12, Week 24

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

    Measured: Baseline, Week 12, Week 24

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

    Measured: Baseline, Week 12, Week 24

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

    Measured: Baseline, Week 12, Week 24

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

    Measured: Baseline, Week 12, Week 24

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

    Measured: 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

    Measured: Baseline, Week 12, Week 24

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

    Measured: Baseline, Week 12, Week 24

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

    Measured: Baseline, Week 12, Week 24

  12. Number of Participants With Adverse Events (AEs)

    Measured: Up to Week 48

  13. Number of Participants With Local and Systemic Injection Reactions

    Measured: Up to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2025
  2. Study start30 Sep 2025
  3. Primary completion14 Sep 2026
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07137585
Sponsor's protocol ID
BP45980
Other IDs
2025-521401-41-00, 2025
Status last verified
Sep 2026
First submitted
15 Aug 2025
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RO7204239 in people with Type 2 Diabetes Mellitus and Obesity, run by Hoffmann-La Roche at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in M-value in a Hyperinsulinemic Euglycemic Glucose Clamp (HEC) at Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07137585.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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