A Study to Compare Different Doses of Tifeglipron (RO7795081) With Placebo or Semaglutide in People With Type 2 Diabetes
Key facts
- Where
- Budapest, Budapest III, Debrecen, Nyíregyháza, Szeged, and Szolnok, HungarySee the 7 sites
- Phase
- Phase 2
Where in Hungary
- Qualiclinic Kft.Budapest, HungaryNo longer taking part
- Clinexpert Kft.Budapest III, HungaryNo longer taking part
- Obudai Egeszseguegyi Centrum Kft.Budapest III, HungaryNo longer taking part
- University of DebrecenDebrecen, HungaryNo longer taking part
- Borbanya Praxis Egeszsegugyi KftNyíregyháza, HungaryNo longer taking part
- University of SzegedSzeged, HungaryNo longer taking part
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-RendelointézetSzolnok, HungaryNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT07112872EU 2024-520322-11-00
- Record updated
- 12 November 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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: Have had 1 or more episodes of Level 3 hypoglycemia or has hypoglycemia unawareness within the 6 months prior to screening; Current treatment or treatment within 3 months of screening with any other anti-hyperglycemic medication except metformin or SGLT-2 inhibitors; 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; Have Type 1 diabetes (T1D), history of ketosis or hyperosmolar state/coma, or any other types of diabetes except T2D; 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 poorly controlled hypertension at screening, untreated renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension; 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); Have a known, clinically significant gastric emptying abnormality.