A Study to Compare Different Doses of RO7795081 With a Placebo or Semaglutide in People With Type 2 Diabetes
NCT ID: NCT07112872
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2025-08-19
2027-02-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1: Placebo
Placebo
Placebo will be taken orally QD during the 30-week treatment period.
Arm 2: Semaglutide 14 mg
Semaglutide
Semaglutide 14 mg will be taken orally QD, with up-titration as per label, during the 30-week treatment period.
Arm 3: RO7795081 Dosing Regimen 1
RO7795081
RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
Arm 4: RO7795081 Dosing Regimen 2
RO7795081
RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
Arm 5: RO7795081 Dosing Regimen 3
RO7795081
RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
Arm 6: RO7795081 Dosing Regimen 4
RO7795081
RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
Arm 7: RO7795081 Dosing Regimen 5
RO7795081
RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
Arm 8: RO7795081 Dosing Regimen 6
RO7795081
RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
Arm 9: RO7795081 Dosing Regimen 7
RO7795081
RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Have had 1 or more episodes of Level 3 hypoglycemia or has hypoglycemia unawareness within the 6 months prior to screening
* 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)
* Current treatment or treatment within 3 months of screening with any other anti-hyperglycemic medication except metformin or SGLT-2 inhibitors
* 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 a known, clinically significant gastric emptying abnormality
* Have poorly controlled hypertension at screening, untreated renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Qualiclinic 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
Osrodek Badan Klinicznych Metabolica
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 Clínico San Carlos
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
Countries
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Central Contacts
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Reference Study ID Number: BP45703 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S. Only)
Email: [email protected]
Other Identifiers
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2024-520322-11-00
Identifier Type: CTIS
Identifier Source: secondary_id
BP45703
Identifier Type: -
Identifier Source: org_study_id