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

Last updated: March 10, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Diabetes Prevention

Treatment

Placebo

Semaglutide

RO7795081

Clinical Study ID

NCT07112872
BP45703
2024-520322-11-00
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of Type 2 diabetes mellitus (T2D) for at least 6 months beforescreening

  • Have an HbA1c ≥7% and ≤10.5% at screening

  • Management of T2D with diet and exercise alone or with either a stable dose ofmetformin 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-reportedbody weight gain and/or loss)

Exclusion

Exclusion Criteria:

  • Have Type 1 diabetes (T1D), history of ketosis or hyperosmolar state/coma, or anyother types of diabetes except T2D

  • Have had 1 or more episodes of Level 3 hypoglycemia or has hypoglycemia unawarenesswithin 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 (includingresting tachycardia, orthostatic hypotension, and diabetic diarrhea)

  • Current treatment or treatment within 3 months of screening with any otheranti-hyperglycemic medication except metformin or SGLT-2 inhibitors

  • Have obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) ordiagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin-4 receptordeficiency 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 toscreening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transientischemic attack; Unstable angina; Hospitalization due to congestive heart failure

Study Design

Total Participants: 240
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 2
Study Start date:
August 19, 2025
Estimated Completion Date:
February 08, 2027

Connect with a study center

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 1036
    Hungary

    Active - Recruiting

  • Qualiclinic Kft.

    Budapest, 1036
    Hungary

    Active - Recruiting

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest 3054643, 1036
    Hungary

    Active - Recruiting

  • Qualiclinic Kft.

    Budapest 3054643, 1036
    Hungary

    Site Not Available

  • NZOZ Osteo-Medic s.c. A. Racewicz, J.Supronik

    Bialystok, Podlaskie Voivodeship 15-351
    Poland

    Active - Recruiting

  • NZOZ Osteo-Medic s.c. A. Racewicz, J.Supronik

    Bialystok 776069, Podlaskie Voivodeship 858789 15-351
    Poland

    Site Not Available

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk, Pomeranian Voivodeship 80-546
    Poland

    Active - Recruiting

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk 3099434, Pomeranian Voivodeship 3337496 80-546
    Poland

    Site Not Available

  • Centrum Medyczne INTERCOR Sp. z o.o.

    Bydgoszcz, 85-605
    Poland

    Active - Recruiting

  • Centrum Medyczne INTERCOR Sp. z o.o.

    Bydgoszcz 3102014, 85-605
    Poland

    Site Not Available

  • Pro Familia Altera Sp z o.o.

    Katowice, 40-648
    Poland

    Active - Recruiting

  • Pro Familia Altera Sp z o.o.

    Katowice 3096472, 40-648
    Poland

    Site Not Available

  • ETG Lublin

    Lublin, 20-412
    Poland

    Active - Recruiting

  • Ekamed sp. z o.o.

    Lublin, 20-718
    Poland

    Active - Recruiting

  • ETG Lublin

    Lublin 765876, 20-412
    Poland

    Active - Recruiting

  • Ekamed sp. z o.o.

    Lublin 765876, 20-718
    Poland

    Site Not Available

  • NZOZ METABOLICA O?rodek Bada? Klinicznych

    Tarnów, 33-100
    Poland

    Active - Recruiting

  • NZOZ METABOLICA O?rodek Bada? Klinicznych

    Tarnów 757026, 33-100
    Poland

    Site Not Available

  • Osrodek Badan Klinicznych Metabolica

    Tarnów 757026, 33-100
    Poland

    Active - Recruiting

  • ETG Warszawa

    Warsaw, 02-677
    Poland

    Active - Recruiting

  • ETG Warszawa

    Warsaw 756135, 02-677
    Poland

    Site Not Available

  • Centrum Bada? Klinicznych

    Wroc?aw, 51-162
    Poland

    Site Not Available

  • Centrum Badan Klinicznych

    Wroclaw, 51-162
    Poland

    Active - Recruiting

  • Centrum Badan Klinicznych

    Wroclaw 3081368, 51-162
    Poland

    Site Not Available

  • ETG Zamosc

    Zamo??, 22-400
    Poland

    Site Not Available

  • ETG Zamosc

    Zamość, 22-400
    Poland

    Active - Recruiting

  • ETG Zamosc

    Zamość 753866, 22-400
    Poland

    Site Not Available

  • Universidad de Sevilla - Hospital Universitario Virgen Macarena

    Seville, Barcelona 41009
    Spain

    Active - Recruiting

  • Universidad de Sevilla - Hospital Universitario Virgen Macarena

    Seville 2510911, Barcelona 41009
    Spain

    Active - Recruiting

  • Instituto De Investigacion Marques De Valdecilla (IDIVAL)

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Instituto De Investigacion Marques De Valdecilla (IDIVAL)

    Santander 3109718, Cantabria 3336898 39008
    Spain

    Site Not Available

  • Hospital Vithas Nisa Sevilla

    Castilleja de la Cuesta, Granada 41950
    Spain

    Active - Recruiting

  • Hospital Vithas Nisa Sevilla

    Castilleja de la Cuesta 2519738, Granada 41950
    Spain

    Site Not Available

  • Hospital Universitario A Coruna

    A Coruña, LA Coruna 15006
    Spain

    Active - Recruiting

  • Hospital Universitario A Coruna

    A Coruña 3119841, LA Coruna 15006
    Spain

    Site Not Available

  • Complexo Hospitalario Universitario de Ferrol (CHUF)

    Ferrol, LA Coruna 15405
    Spain

    Active - Recruiting

  • Complexo Hospitalario Universitario de Ferrol (CHUF)

    Ferrol 3123493, LA Coruna 15405
    Spain

    Site Not Available

  • Hospital Regional Universitario de Malaga

    Malaga, Madrid 29011
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, Malaga 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga 2514256, Malaga 29010
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • centro Medico Teknon

    Barcelona, 08022
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

    Barcelona 3128760, 08036
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • centro Medico Teknon

    Barcelona 3128760, 08022
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Maranon (HGUGM)

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Jimenez Díaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Clínico San Carlos

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Maranon (HGUGM)

    Madrid 3117735, 28007
    Spain

    Site Not Available

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010
    Spain

    Active - Recruiting

  • Nuevas Tecnologias en Diabetes y Endocrinologia

    Seville, 41003
    Spain

    Active - Recruiting

  • Hospital Quironsalud Infanta Luisa

    Seville 2510911, 41010
    Spain

    Active - Recruiting

  • Nuevas Tecnologias en Diabetes y Endocrinologia

    Seville 2510911, 41003
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria INCLIVA)

    Valencia, 46010
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria INCLIVA)

    Valencia 2509954, 46010
    Spain

    Site Not Available

  • Arizona Liver Health - Tucson

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • Arizona Liver Health - Tucson

    Tucson 5318313, Arizona 5551752 85712
    United States

    Site Not Available

  • Orange County Research Center

    Lake Forest, California 92630
    United States

    Active - Recruiting

  • Prospective Research Innovations Inc.

    Rancho Cucamonga, California 91730
    United States

    Active - Recruiting

  • Encompass Clinical Research

    Spring Valley, California 91978
    United States

    Active - Recruiting

  • Orange County Research Center

    Lake Forest 5364514, California 5332921 92630
    United States

    Site Not Available

  • Prospective Research Innovations Inc.

    Rancho Cucamonga 5385955, California 5332921 91730
    United States

    Site Not Available

  • Encompass Clinical Research

    Spring Valley 5398277, California 5332921 91978
    United States

    Site Not Available

  • Chase Medical Research

    Waterbury, Connecticut 06708-3346
    United States

    Active - Recruiting

  • Chase Medical Research

    Waterbury 4845193, Connecticut 4831725 06708-3346
    United States

    Site Not Available

  • Emerson Clinical Research Institute

    Washington, District of Columbia 20009
    United States

    Site Not Available

  • Emerson Clinical Research Institute

    Washington D.C., District of Columbia 20009
    United States

    Active - Recruiting

  • Emerson Clinical Research Institute

    Washington D.C. 4140963, District of Columbia 4138106 20009
    United States

    Site Not Available

  • K2 Medical Research South Orlando, LLC

    Clermont, Florida 34711
    United States

    Active - Recruiting

  • Center for Diabetes, Obesity and Metabolism Inc

    Pembroke Pines, Florida 33024
    United States

    Active - Recruiting

  • K2 Medical Research South Orlando, LLC

    Clermont 4151352, Florida 4155751 34711
    United States

    Site Not Available

  • K2 Medical Research South Orlando, LLC

    Orlando 4167147, Florida 4155751 32806
    United States

    Site Not Available

  • Center for Diabetes, Obesity and Metabolism Inc

    Pembroke Pines 4168139, Florida 4155751 33024
    United States

    Site Not Available

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia 30291
    United States

    Active - Recruiting

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City 4227777, Georgia 4197000 30291
    United States

    Site Not Available

  • Accellacare of Duly Health and Care

    Oak Lawn, Illinois 60453
    United States

    Active - Recruiting

  • Accellacare of Duly Health and Care

    Oak Lawn 4904365, Illinois 4896861 60453
    United States

    Site Not Available

  • Mercury Street Medical Group, PLLC

    Butte, Montana 59701
    United States

    Active - Recruiting

  • Mercury Street Medical Group, PLLC

    Butte 5642934, Montana 5667009 59701
    United States

    Site Not Available

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York 11516
    United States

    Active - Recruiting

  • Neurobehavioral Research, Inc.

    Cedarhurst 5111974, New York 5128638 11516
    United States

    Site Not Available

  • Accellacare of Piedmont Healthcare

    Statesville, North Carolina 28625
    United States

    Active - Recruiting

  • Accellacare of Wilmington, LLC

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

  • Accellacare of Piedmont Healthcare

    Statesville 4493316, North Carolina 4482348 28625
    United States

    Site Not Available

  • Accellacare of Wilmington, LLC

    Wilmington 4499379, North Carolina 4482348 28401
    United States

    Site Not Available

  • NexGen Research

    Lima, Ohio 45801
    United States

    Active - Recruiting

  • NexGen Research

    Lima 5160783, Ohio 5165418 45801
    United States

    Site Not Available

  • Tristar Clinical Investigations

    Philadelphia, Pennsylvania 19114
    United States

    Active - Recruiting

  • Tristar Clinical Investigations

    Philadelphia 4560349, Pennsylvania 6254927 19114
    United States

    Site Not Available

  • Alliance for Multispecialty Research. LLC

    Knoxville, Tennessee 37909
    United States

    Active - Recruiting

  • Clinical Research Associates

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research. LLC

    Knoxville 4634946, Tennessee 4662168 37909
    United States

    Site Not Available

  • Clinical Research Associates

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas 78731
    United States

    Active - Recruiting

  • Apex Mobile Clinical Research

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Velocity Clinical Research (Impact Research Institute)

    Waco, Texas 76710
    United States

    Active - Recruiting

  • Texas Diabetes & Endocrinology, P.A.

    Austin 4671654, Texas 4736286 78731
    United States

    Site Not Available

  • Apex Mobile Clinical Research

    Bellaire 4673353, Texas 4736286 77401
    United States

    Site Not Available

  • Velocity Clinical Research

    Dallas 4684888, Texas 4736286 75230
    United States

    Site Not Available

  • Velocity Clinical Research (Impact Research Institute)

    Waco 4739526, Texas 4736286 76710
    United States

    Site Not Available

  • Chrysalis Clinical Research

    St. George, Utah 84790
    United States

    Active - Recruiting

  • Chrysalis Clinical Research

    St. George 5546220, Utah 5549030 84790
    United States

    Site Not Available

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Active - Recruiting

  • Manassas Clinical Research Center

    Manassas 4771401, Virginia 6254928 20110
    United States

    Site Not Available

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