A Study to Compare Different Doses of RO7795081 With a Placebo or Semaglutide in People With Type 2 Diabetes

Launched by HOFFMANN-LA ROCHE · Aug 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called RO7795081 to see how well it helps control blood sugar in adults with Type 2 diabetes. The study will compare different doses of this medicine to a placebo (a pill with no active drug) and to another diabetes medicine called semaglutide. The main goal is to find out if RO7795081 is safe, tolerable, and effective at lowering blood sugar levels.

Adults aged 18 to 74 with Type 2 diabetes for at least six months may be eligible if their blood sugar levels are moderately high (measured by a test called HbA1c between 7% and 10.5%) and if they manage their diabetes through diet and exercise or with certain common diabetes medicines like metformin or SGLT-2 inhibitors. People with other types of diabetes, serious eye or kidney problems, recent heart issues, or certain other health conditions won’t be able to join. Participants can expect to be randomly assigned to receive either RO7795081, semaglutide, or a placebo, and the study will carefully monitor their blood sugar, overall health, and any side effects. This trial is not yet recruiting, but it aims to help find better treatment options for people living with Type 2 diabetes.

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Eligibility criteria

• Inclusion Criteria:
• • Have a diagnosis of Type 2 diabetes mellitus (T2D) for at least 6 months before screening
• • Have an HbA1c ≥7% and ≤10.5% at screening
• • Management of T2D with diet and exercise alone or with either a stable dose of metformin or/and sodium-glucose cotransporter-2 (SGLT-2) inhibitors
• • Body mass index (BMI) ≥23.0 kg/m\^2 at screening
• • A stable body weight within 3 months prior to screening (maximum 5% self-reported body weight gain and/or loss)
• Exclusion Criteria:
• • Have Type 1 diabetes (T1D), history of ketosis or hyperosmolar state/coma, or any other types of diabetes except T2D
• • Have had 1 or more episodes of Level 3 hypoglycemia or has hypoglycemia unawareness within the 6 months prior to screening
• • History or presence of proliferative diabetic retinopathy, diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment
• • Evidence of clinically significant/active nephropathy or neuropathy (including resting tachycardia, orthostatic hypotension, and diabetic diarrhea)
• • Current treatment or treatment within 3 months of screening with any other anti-hyperglycemic medication except metformin or SGLT-2 inhibitors
• • Have obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin-4 receptor deficiency or Prader-Willi Syndrome)
• • Have a known, clinically significant gastric emptying abnormality
• • Have poorly controlled hypertension at screening, untreated renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension
• • Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure