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Clinical Trials in the USA / NCT07112872
Active, not recruiting Phase 2

A Study to Compare Different Doses of RO7795081 With a Placebo or Semaglutide in People With Type 2 Diabetes

NCT07112872 · tracked via the Priya Life Science USA tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Started
2025-08-19
Last updated
2026-07-07

Condition(s) studied

Type 2 Diabetes Mellitus

Investigational drug(s) / intervention(s)

RO7795081SemaglutidePlacebo

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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) Exclusion Criteria: * Have Type 1 diabetes (T1D), history of ketosis or hyperosmolar state/coma, or any other types of diabetes except T2D * 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

Primary outcome measure(s)

Trial sites (50)

FacilityCityRegionStatus
Arizona Liver Health - Tucson Tucson Arizona
Orange County Research Center Lake Forest California
Prospective Research Innovations Inc. Rancho Cucamonga California
Encompass Clinical Research Spring Valley California
Chase Medical Research Waterbury Connecticut
Emerson Clinical Research Institute Washington D.C. District of Columbia
K2 Medical Research South Orlando, LLC Clermont Florida
Center for Diabetes, Obesity and Metabolism Inc Pembroke Pines Florida
Rophe Adult and Pediatric Medicine/SKYCRNG Union City Georgia
Accellacare of Duly Health and Care Oak Lawn Illinois
Mercury Street Medical Group, PLLC Butte Montana
Neurobehavioral Research, Inc. Cedarhurst New York
Accellacare of Piedmont Healthcare Statesville North Carolina
Accellacare of Wilmington, LLC Wilmington North Carolina
NexGen Research Lima Ohio
Tristar Clinical Investigations Philadelphia Pennsylvania
Alliance for Multispecialty Research. LLC Knoxville Tennessee
Clinical Research Associates Nashville Tennessee
Texas Diabetes & Endocrinology, P.A. Austin Texas
Apex Mobile Clinical Research Bellaire Texas
Velocity Clinical Research Dallas Texas
Velocity Clinical Research (Impact Research Institute) Waco Texas
Chrysalis Clinical Research St. George Utah
Manassas Clinical Research Center Manassas Virginia
Obudai Egeszsegugyi Centrum Kft. Budapest Hungary
NZOZ Osteo-Medic s.c. A. Racewicz, J.Supronik Bialystok Podlaskie Voivodeship
Centrum Badan Klinicznych PI-House sp. z o.o. Gdansk Pomeranian Voivodeship
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
Instituto De Investigacion Marques De Valdecilla (IDIVAL) Santander Cantabria
Hospital Vithas Nisa Sevilla Castilleja de la Cuesta Granada
Hospital Universitario A Coruna A Coruña LA Coruna
Complexo Hospitalario Universitario de Ferrol (CHUF) Ferrol LA Coruna

+ 10 more sites — see the full list on the official registry below.

On this site

📄 Ozempic (semaglutide) drug profile →

More Hoffmann-La Roche trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07112872 on ClinicalTrials.gov ↗ ← All trials in the USA