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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

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

RO7204239

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

Group Type EXPERIMENTAL

RO7204239

Intervention Type DRUG

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

Interventions

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Placebo

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

Intervention Type DRUG

RO7204239

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

Intervention Type DRUG

Other Intervention Names

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GYM329

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No