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A Study to Compare Different Doses of Tifeglipron (RO7795081) With Placebo or Semaglutide in People With Type 2 Diabetes
A Randomized, Double-Blind, Placebo- and Open-Label Active Comparator- Controlled, Parallel-Group, Multi-Center Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Daily RO7795081 Administered for 30 Weeks to Participants With Type 2 Diabetes Mellitus
Who can join
Ages 18 and older · All sexes
Full 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
About the study
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 different doses of tifeglipron for glycemic control in adult participants with Type 2 diabetes mellitus (T2D).
What is being tested
- Tifeglipron (drug)
- Semaglutide (drug)
- Placebo (drug)
Sponsor: Hoffmann-La Roche · Participants: 330 · Started: Aug 19, 2025
Contact the study team
- Reference Study ID Number: BP45703 https://forpatients.roche.com/ No attachments to email below. · Phone: 888-662-6728 (U.S. Only)
Official record on ClinicalTrials.gov — NCT07112872
Locations in the U.S.
| Arizona | Arizona Liver Health - Tucson, Tucson |
| California | Orange County Research Center, Lake Forest Prospective Research Innovations Inc., Rancho Cucamonga Encompass Clinical Research, Spring Valley |
| Connecticut | Chase Medical Research, Waterbury |
| District of Columbia | Emerson Clinical Research Institute, Washington D.C. |
| North Carolina | Accellacare of Piedmont Healthcare, Statesville Accellacare of Wilmington, LLC, Wilmington |
| Pennsylvania | Tristar Clinical Investigations, Philadelphia |
| Virginia | Manassas Clinical Research Center, Manassas |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.