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A Study to Compare Different Doses of RO7795081 With a Placebo or Semaglutide in People With Type 2 Diabetes
Sponsor: Hoffmann-La Roche
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2025-08-19
Completion Date
2026-11-27
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
RO7795081
RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
Semaglutide
Semaglutide 14 mg will be taken orally QD, with up-titration as per label, during the 30-week treatment period.
Placebo
Placebo will be taken orally QD during the 30-week treatment period.
Locations (50)
Arizona Liver Health - Tucson
Tucson, Arizona, United States
Orange County Research Center
Lake Forest, California, United States
Prospective Research Innovations Inc.
Rancho Cucamonga, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Chase Medical Research
Waterbury, Connecticut, United States
Emerson Clinical Research Institute
Washington D.C., District of Columbia, United States
K2 Medical Research South Orlando, LLC
Clermont, Florida, United States
Center for Diabetes, Obesity and Metabolism Inc
Pembroke Pines, Florida, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States
Accellacare of Duly Health and Care
Oak Lawn, Illinois, United States
Mercury Street Medical Group, PLLC
Butte, Montana, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
Accellacare of Piedmont Healthcare
Statesville, North Carolina, United States
Accellacare of Wilmington, LLC
Wilmington, North Carolina, United States
NexGen Research
Lima, Ohio, United States
Tristar Clinical Investigations
Philadelphia, Pennsylvania, United States
Alliance for Multispecialty Research. LLC
Knoxville, Tennessee, United States
Clinical Research Associates
Nashville, Tennessee, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, United States
Apex Mobile Clinical Research
Bellaire, Texas, United States
Velocity Clinical Research
Dallas, Texas, United States
Velocity Clinical Research (Impact Research Institute)
Waco, Texas, United States
Chrysalis Clinical Research
St. George, Utah, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Obudai Egeszsegugyi Centrum Kft.
Budapest, Hungary
NZOZ Osteo-Medic s.c. A. Racewicz, J.Supronik
Bialystok, Podlaskie Voivodeship, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland
Centrum Medyczne INTERCOR Sp. z o.o.
Bydgoszcz, Poland
Pro Familia Altera Sp z o.o.
Katowice, Poland
ETG Lublin
Lublin, Poland
Ekamed sp. z o.o.
Lublin, Poland
NZOZ METABOLICA O?rodek Bada? Klinicznych
Tarnów, Poland
ETG Warszawa
Warsaw, Poland
Centrum Badan Klinicznych
Wroclaw, Poland
ETG Zamosc
Zamość, Poland
Universidad de Sevilla - Hospital Universitario Virgen Macarena
Seville, Barcelona, Spain
Instituto De Investigacion Marques De Valdecilla (IDIVAL)
Santander, Cantabria, Spain
Hospital Vithas Nisa Sevilla
Castilleja de la Cuesta, Granada, Spain
Hospital Universitario A Coruna
A Coruña, LA Coruna, Spain
Complexo Hospitalario Universitario de Ferrol (CHUF)
Ferrol, LA Coruna, Spain
Hospital Regional Universitario de Malaga
Malaga, Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Malaga, Spain
centro Medico Teknon
Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona, Spain
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, Spain
Hospital Universitario Fundación Jimenez Díaz
Madrid, Spain
Nuevas Tecnologias en Diabetes y Endocrinologia
Seville, Spain
Hospital Quironsalud Infanta Luisa
Seville, Spain
Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria INCLIVA)
Valencia, Spain