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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-520322-11-00 | EU Trial (CTIS) Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Placebo | Placebo Comparator |
| |
| Arm 2: Semaglutide 14 mg | Active Comparator |
| |
| Arm 3: RO7795081 Dosing Regimen 1 | Experimental |
| |
| Arm 4: RO7795081 Dosing Regimen 2 | Experimental |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7795081 | Drug | RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| RO7795081 vs. Placebo: Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 30 | Baseline to Week 30 |
| Measure | Description | Time Frame |
|---|---|---|
| RO7795081 vs. Semaglutide: Change in HbA1c from Baseline at Week 30 | Baseline to Week 30 | |
| Percentage of Participants with HbA1c <5.7%, ≤6.5%, and <7.0% at Week 30 | Week 30 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Liver Health - Tucson | Tucson | Arizona | 85712 | United States | ||
| Orange County Research Center |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Experimental |
|
| Arm 9: RO7795081 Dosing Regimen 7 | Experimental |
|
|
| Semaglutide | Drug | Semaglutide 14 mg will be taken orally QD, with up-titration as per label, during the 30-week treatment period. |
|
| Placebo | Drug | Placebo will be taken orally QD during the 30-week treatment period. |
|
| Change in Fasting Plasma Glucose from Baseline at Week 30 |
| Baseline to Week 30 |
| Percent Change in Body Weight from Baseline at Week 30 | Baseline to Week 30 |
| Absolute Change in Body Weight (kg) from Baseline at Week 30 | Baseline to Week 30 |
| Percentage of Participants Who Achieve ≥5%, ≥10%, or ≥15% Body Weight Reduction from Baseline at Week 30 | Baseline and Week 30 |
| Incidence of Adverse Events (AEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) | From first dose until 28 days after the final dose of study treatment (34 weeks) |
| Number of Participants with Documented Hypoglycemia (Level 1, 2, or 3 per American Diabetes Association 2025) | From first dose until 28 days after the final dose of study treatment (34 weeks) |
| Plasma Concentrations of RO7795081 at Prespecified Timepoints | Predose on Day 1 and at prespecified timepoints until Week 30 |
| Lake Forest |
| California |
| 92630 |
| United States |
| Prospective Research Innovations Inc. | Rancho Cucamonga | California | 91730 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Chase Medical Research | Waterbury | Connecticut | 06708-3346 | United States |
| Emerson Clinical Research Institute | Washington D.C. | District of Columbia | 20009 | United States |
| K2 Medical Research South Orlando, LLC | Clermont | Florida | 34711 | United States |
| Center for Diabetes, Obesity and Metabolism Inc | Pembroke Pines | Florida | 33024 | United States |
| Rophe Adult and Pediatric Medicine/SKYCRNG | Union City | Georgia | 30291 | United States |
| Accellacare of Duly Health and Care | Oak Lawn | Illinois | 60453 | United States |
| Mercury Street Medical Group, PLLC | Butte | Montana | 59701 | United States |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | United States |
| Accellacare of Piedmont Healthcare | Statesville | North Carolina | 28625 | United States |
| Accellacare of Wilmington, LLC | Wilmington | North Carolina | 28401 | United States |
| NexGen Research | Lima | Ohio | 45801 | United States |
| Tristar Clinical Investigations | Philadelphia | Pennsylvania | 19114 | United States |
| Alliance for Multispecialty Research. LLC | Knoxville | Tennessee | 37909 | United States |
| Clinical Research Associates | Nashville | Tennessee | 37203 | United States |
| Texas Diabetes & Endocrinology, P.A. | Austin | Texas | 78731 | United States |
| Apex Mobile Clinical Research | Bellaire | Texas | 77401 | United States |
| Velocity Clinical Research | Dallas | Texas | 75230 | United States |
| Velocity Clinical Research (Impact Research Institute) | Waco | Texas | 76710 | United States |
| Chrysalis Clinical Research | St. George | Utah | 84790 | United States |
| Manassas Clinical Research Center | Manassas | Virginia | 20110 | United States |
| Obudai Egeszsegugyi Centrum Kft. | Budapest | 1036 | Hungary |
| NZOZ Osteo-Medic s.c. A. Racewicz, J.Supronik | Bialystok | Podlaskie Voivodeship | 15-351 | Poland |
| Centrum Badan Klinicznych PI-House sp. z o.o. | Gdansk | Pomeranian Voivodeship | 80-546 | Poland |
| Centrum Medyczne INTERCOR Sp. z o.o. | Bydgoszcz | 85-605 | Poland |
| Pro Familia Altera Sp z o.o. | Katowice | 40-648 | Poland |
| ETG Lublin | Lublin | 20-412 | Poland |
| Ekamed sp. z o.o. | Lublin | 20-718 | Poland |
| NZOZ METABOLICA O?rodek Bada? Klinicznych | Tarnów | 33-100 | Poland |
| ETG Warszawa | Warsaw | 02-677 | Poland |
| Centrum Badan Klinicznych | Wroclaw | 51-162 | Poland |
| ETG Zamosc | Zamość | 22-400 | Poland |
| Universidad de Sevilla - Hospital Universitario Virgen Macarena | Seville | Barcelona | 41009 | Spain |
| Instituto De Investigacion Marques De Valdecilla (IDIVAL) | Santander | Cantabria | 39008 | Spain |
| Hospital Vithas Nisa Sevilla | Castilleja de la Cuesta | Granada | 41950 | Spain |
| Hospital Universitario A Coruna | A Coruña | LA Coruna | 15006 | Spain |
| Complexo Hospitalario Universitario de Ferrol (CHUF) | Ferrol | LA Coruna | 15405 | Spain |
| Hospital Regional Universitario de Malaga | Malaga | Madrid | 29011 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | Malaga | 29010 | Spain |
| Centro Medico Teknon | Barcelona | 08022 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona (Hospital Clinic i Provincial) | Barcelona | 08036 | Spain |
| Hospital General Universitario Gregorio Maranon (HGUGM) | Madrid | 28007 | Spain |
| Hospital Universitario Fundación Jimenez Díaz | Madrid | 28040 | Spain |
| Nuevas Tecnologias en Diabetes y Endocrinologia | Seville | 41003 | Spain |
| Hospital Quironsalud Infanta Luisa | Seville | 41010 | Spain |
| Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria INCLIVA) | Valencia | 46010 | Spain |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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