Clinical trial
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
Active, not recruiting · Phase 1 · 1 countries · Registry ID NCT07137585
Active, not recruitingPhase 1Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes Mellitus, Obesity, Overweight
Full registry criteria
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
Treatments and study arms
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.
Primary outcomes
Change From Baseline in M-value in a Hyperinsulinemic Euglycemic Glucose Clamp (HEC) at Week 24Baseline, Week 24
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Profil Institut für Stoffwechselforschung🇩🇪 Homburg, Saarland, Germany