NCT07112872Active, not recruitingPhase 2
A Study to Compare Different Doses of 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
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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 RO7795081 for glycemic control in adult participants with Type 2 diabetes mellitus (T2D).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 330 (estimated)
- First submitted
- 1 Aug 2025
- Start date
- 19 Aug 2025
- Primary completion date
- 5 Feb 2028
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Type 2 diabetes
- NCT number
- NCT07112872
- EU CT number
- 2024-520322-11-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 330
- From 19 Aug 2025 to the primary completion date, 5 Feb 2028
- 53 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (53)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Centro Medico Teknon - Grupo Quironsalud Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Nisa Sevilla Aljarafe Coordinator of this site? Confirm its status | Castilleja De La Cuesta | Spain | Active, not recruiting |
| Area Sanitaria De Ferrol Coordinator of this site? Confirm its status | Ferrol | Spain | Active, not recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Quironsalud Infanta Luisa Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Qualiclinic Kft. Coordinator of this site? Confirm its status | Budapest | Hungary | Active, not recruiting |
| Clinexpert Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Active, not recruiting |
| Obudai Egeszseguegyi Centrum Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Active, not recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Active, not recruiting |
| Borbanya Praxis Egeszsegugyi Kft Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Active, not recruiting |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Active, not recruiting |
| Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointézet Coordinator of this site? Confirm its status | Szolnok | Hungary | Active, not recruiting |
| Osteo Medic s.c. Artur Racewicz, Jerzy Supronik Coordinator of this site? Confirm its status | Białystok | Poland | Active, not recruiting |
| Centrum Medyczne INTERCOR Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Active, not recruiting |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Pro Familia Altera Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Active, not recruiting |
| EKAMED sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| ETG Lublin Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Metabolica Sp. z o.o. Coordinator of this site? Confirm its status | Tarnów | Poland | Active, not recruiting |
| Etg Warszawa Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p. Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Etg Zamosc Sp. z o.o. Coordinator of this site? Confirm its status | Zamość | Poland | Active, not recruiting |
| Texas Diabetes & Endocrinology, P.A. Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Apex Mobile Clinical Research Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Neurobehavioral Research, Inc. Coordinator of this site? Confirm its status | Cedarhurst | United States | Unknown status |
| K2 Medical Research South Orlando, LLC Coordinator of this site? Confirm its status | Clermont | United States | Unknown status |
| Velocity Clinical Research Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Orange County Research Center Coordinator of this site? Confirm its status | Lake Forest | United States | Unknown status |
| NexGen Research Coordinator of this site? Confirm its status | Lima | United States | Unknown status |
| Manassas Clinical Research Center Coordinator of this site? Confirm its status | Manassas | United States | Unknown status |
| Clinical Research Associates Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Accellacare of Duly Health and Care Coordinator of this site? Confirm its status | Oak Lawn | United States | Unknown status |
| Center for Diabetes, Obesity and Metabolism Inc Coordinator of this site? Confirm its status | Pembroke Pines | United States | Unknown status |
| Tristar Clinical Investigations Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Prospective Research Innovations Inc Coordinator of this site? Confirm its status | Rancho Cucamonga | United States | Unknown status |
| Encompass Clinical Research Coordinator of this site? Confirm its status | Spring Valley | United States | Unknown status |
| Accellacare of Piedmont HealthCare Coordinator of this site? Confirm its status | Statesville | United States | Unknown status |
| Chrysalis Clinical Research Coordinator of this site? Confirm its status | St. George | United States | Unknown status |
| Arizona Liver Health - Tucson Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Rophe Adult and Pediatric Medicine/SKYCRNG Coordinator of this site? Confirm its status | Union City | United States | Unknown status |
| Emerson Clinical Research Institute Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Chase Medical Research Coordinator of this site? Confirm its status | Waterbury | United States | Unknown status |
| Accellacare of Wilmington, LLC Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.