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

Summary

This multicenter, randomized, double-blind, placebo- and open-label active comparator-controlled, parallel-group, dose-range-finding, Phase II study aims to evaluate the efficacy, tolerability, and safety of RO7795081 for glycemic control in adult participants with Type 2 diabetes mellitus (T2D).

Eligibility

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

Conditions2

Interventions2

Locations24 sites

Find trials near these locations

Related trials

• A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver — Boehringer Ingelheim
• A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia — BrightGene Bio-Medical Technology Co., Ltd.
• A Study of the Effect of (S)-Pindolol Benzoate (ACM-001.1) on Lean Body Mass (LBM) in Obese Patents During (PROACT 1), and Post-semaglutide Therapy (PROACT 2) — Actimed Therapeutics Ltd
• A Study to Evaluate the Effect of Retatrutide on Insulin Secretion and Insulin Sensitivity in Adult Participants With Type 2 Diabetes Mellitus — Eli Lilly and Company
• COMMETS- Combination MCI Metabolic Syndrome — Rutgers, The State University of New Jersey
• Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes — Mostafa Bahaa
• GLP1-RAs Effects on Inflammatory and Endothelial Biomarkers in T2DM — Federico II University
• Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes — Steno Diabetes Center Copenhagen

Browse More Trials