RecruitingPhase 2NCT07112872

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

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

Sponsor

Hoffmann-La Roche

Enrollment

240 participants

Start Date

Aug 19, 2025

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes Mellitus

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing different doses of RO7795081 — a new experimental diabetes drug — compared to a placebo and to semaglutide (a well-known GLP-1 drug like Ozempic) in people with type 2 diabetes. Researchers want to find the right dose and assess how well the new drug lowers blood sugar and body weight. **You may be eligible if...** - You have had type 2 diabetes for at least 6 months - Your HbA1c is between 7% and 10.5% - You are managing your diabetes with diet and exercise alone, or with stable doses of metformin and/or SGLT-2 inhibitors - Your BMI is 23 or above - Your weight has been stable for the past 3 months (within 5%) **You may NOT be eligible if...** - You have type 1 diabetes or any other diabetes type besides type 2 - You have had severe low blood sugar episodes (level 3 hypoglycemia) or cannot feel when your blood sugar is low - You have advanced diabetic eye, kidney, or nerve complications - You are on other diabetes medications (besides metformin and SGLT-2 inhibitors) - You have obesity-related conditions requiring specific medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRO7795081

RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.

DRUGSemaglutide

Semaglutide 14 mg will be taken orally QD, with up-titration as per label, during the 30-week treatment period.

DRUGPlacebo

Placebo will be taken orally QD during the 30-week treatment period.

Locations(51)

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

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

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NCT07112872

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