NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07137585

Active Not RecruitingPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Type 2 Diabetes Mellitus, Obesity, Overweight

Interventions: Placebo, RO7204239

Countries: Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Homburg, Saarland, Germany