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: Recruiting
Location: See all (46) 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
RECRUITING
Tucson
California
Orange County Research Center
RECRUITING
Lake Forest
Prospective Research Innovations Inc.
RECRUITING
Rancho Cucamonga
Encompass Clinical Research
RECRUITING
Spring Valley
Connecticut
Chase Medical Research
RECRUITING
Waterbury
Washington, D.c.
Emerson Clinical Research Institute
RECRUITING
Washington D.c.
Florida
K2 Medical Research South Orlando, LLC
RECRUITING
Orlando
Center for Diabetes, Obesity and Metabolism Inc
RECRUITING
Pembroke Pines
Georgia
Rophe Adult and Pediatric Medicine/SKYCRNG
RECRUITING
Union City
Illinois
Accellacare of Duly Health and Care
RECRUITING
Oak Lawn
Montana
Mercury Street Medical Group, PLLC
RECRUITING
Butte
North Carolina
Accellacare of Piedmont Healthcare
RECRUITING
Statesville
Accellacare of Wilmington, LLC
RECRUITING
Wilmington
New York
Neurobehavioral Research, Inc.
RECRUITING
Cedarhurst
Ohio
NexGen Research
RECRUITING
Lima
Pennsylvania
Tristar Clinical Investigations
RECRUITING
Philadelphia
Tennessee
Alliance for Multispecialty Research. LLC
RECRUITING
Knoxville
Clinical Research Associates
RECRUITING
Nashville
Texas
Texas Diabetes & Endocrinology, P.A.
RECRUITING
Austin
Apex Mobile Clinical Research
RECRUITING
Bellaire
Velocity Clinical Research
RECRUITING
Dallas
Velocity Clinical Research (Impact Research Institute)
RECRUITING
Waco
Utah
Chrysalis Clinical Research
RECRUITING
St. George
Virginia
Manassas Clinical Research Center
RECRUITING
Manassas
Other Locations
Poland
Centrum Medyczne INTERCOR Sp. z o.o.
RECRUITING
Bydgoszcz
Centrum Badan Klinicznych PI-House sp. z o.o.
RECRUITING
Gdansk
Pro Familia Altera Sp z o.o.
RECRUITING
Katowice
Ekamed sp. z o.o.
RECRUITING
Lublin
ETG Lublin
RECRUITING
Lublin
Osrodek Badan Klinicznych Metabolica
RECRUITING
Tarnów
ETG Warszawa
RECRUITING
Warsaw
Centrum Badan Klinicznych
RECRUITING
Wroclaw
ETG Zamosc
RECRUITING
Zamość
Spain
Hospital Universitario A Coruna
RECRUITING
A Coruña
centro Medico Teknon
RECRUITING
Barcelona
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Hospital Vithas Nisa Sevilla
RECRUITING
Castilleja De La Cuesta
Complexo Hospitalario Universitario de Ferrol (CHUF)
RECRUITING
Ferrol
Hospital Regional Universitario de Malaga
RECRUITING
Malaga
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Instituto De Investigacion Marques De Valdecilla (IDIVAL)
RECRUITING
Santander
Hospital Quironsalud Infanta Luisa
RECRUITING
Seville
Nuevas Tecnologias en Diabetes y Endocrinologia
RECRUITING
Seville
Universidad de Sevilla - Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria INCLIVA)
RECRUITING
Valencia
Contact Information
Primary
Reference Study ID Number: BP45703 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date: 2025-08-19
Estimated Completion Date: 2027-02-08
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