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

RecruitingPhase 2

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

Sponsor: Hoffmann-La Roche · Participants: 330 · Started: Aug 19, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07112872

Locations in the U.S.

ArizonaArizona Liver Health - Tucson, Tucson
CaliforniaOrange County Research Center, Lake Forest
Prospective Research Innovations Inc., Rancho Cucamonga
Encompass Clinical Research, Spring Valley
ConnecticutChase Medical Research, Waterbury
District of ColumbiaEmerson Clinical Research Institute, Washington D.C.
North CarolinaAccellacare of Piedmont Healthcare, Statesville
Accellacare of Wilmington, LLC, Wilmington
PennsylvaniaTristar Clinical Investigations, Philadelphia
VirginiaManassas 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.