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
Status: Active_not_recruiting
Location: See all (50) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
United States
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
Washington, D.c.
Emerson Clinical Research Institute
Washington D.c.
Florida
K2 Medical Research South Orlando, LLC
Clermont
Center for Diabetes, Obesity and Metabolism Inc
Pembroke Pines
Georgia
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City
Illinois
Accellacare of Duly Health and Care
Oak Lawn
Montana
Mercury Street Medical Group, PLLC
Butte
North Carolina
Accellacare of Piedmont Healthcare
Statesville
Accellacare of Wilmington, LLC
Wilmington
New York
Neurobehavioral Research, Inc.
Cedarhurst
Ohio
NexGen Research
Lima
Pennsylvania
Tristar Clinical Investigations
Philadelphia
Tennessee
Alliance for Multispecialty Research. LLC
Knoxville
Clinical Research Associates
Nashville
Texas
Texas Diabetes & Endocrinology, P.A.
Austin
Apex Mobile Clinical Research
Bellaire
Velocity Clinical Research
Dallas
Velocity Clinical Research (Impact Research Institute)
Waco
Utah
Chrysalis Clinical Research
St. George
Virginia
Manassas Clinical Research Center
Manassas
Other Locations
Hungary
Obudai Egeszsegugyi Centrum Kft.
Budapest
Poland
NZOZ Osteo-Medic s.c. A. Racewicz, J.Supronik
Bialystok
Centrum Medyczne INTERCOR Sp. z o.o.
Bydgoszcz
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk
Pro Familia Altera Sp z o.o.
Katowice
Ekamed sp. z o.o.
Lublin
ETG Lublin
Lublin
NZOZ METABOLICA O?rodek Bada? Klinicznych
Tarnów
ETG Warszawa
Warsaw
Centrum Badan Klinicznych
Wroclaw
ETG Zamosc
Zamość
Spain
Hospital Universitario A Coruna
A Coruña
centro Medico Teknon
Barcelona
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
Hospital Vithas Nisa Sevilla
Castilleja De La Cuesta
Complexo Hospitalario Universitario de Ferrol (CHUF)
Ferrol
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid
Hospital Universitario Fundación Jimenez Díaz
Madrid
Hospital Regional Universitario de Malaga
Malaga
Hospital Universitario Virgen de la Victoria
Málaga
Instituto De Investigacion Marques De Valdecilla (IDIVAL)
Santander
Hospital Quironsalud Infanta Luisa
Seville
Nuevas Tecnologias en Diabetes y Endocrinologia
Seville
Universidad de Sevilla - Hospital Universitario Virgen Macarena
Seville
Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria INCLIVA)
Valencia
Time Frame
Start Date: 2025-08-19
Completion Date: 2026-11-27
Participants
Target number of participants: 240
Treatments
Placebo_comparator: Arm 1: Placebo
Active_comparator: Arm 2: Semaglutide 14 mg
Experimental: Arm 3: RO7795081 Dosing Regimen 1
Experimental: Arm 4: RO7795081 Dosing Regimen 2
Experimental: Arm 5: RO7795081 Dosing Regimen 3
Experimental: Arm 6: RO7795081 Dosing Regimen 4
Experimental: Arm 7: RO7795081 Dosing Regimen 5
Experimental: Arm 8: RO7795081 Dosing Regimen 6
Experimental: Arm 9: RO7795081 Dosing Regimen 7
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche