> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-compare-different-doses-of-ro7795081-with-placebo-38e034a6-8142-44ae-ad81-e7d56098fb6b > Record changed: 2026-11-04 # A Study to Compare Different Doses of RO7795081 With Placebo or Semaglutide in People With Type 2 Diabetes NCT07112872 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) Participants 330 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) Lead sponsor Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) Start date 2025-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) Number of sites 46 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) ## Title and summary **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 different doses of RO7795081 for glycemic control in adult participants with Type 2 diabetes mellitus (T2D). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **Short title** A Study to Compare Different Doses of RO7795081 With Placebo or Semaglutide in People With Type 2 Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) ## Dates **Completion date** 2028-02-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **First posted** 2025-08-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **Registry last updated** 2026-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **Primary completion date** 2028-02-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **Start date** 2025-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) ## Size and sites **Participants** 330 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **Planned participants** 330 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **Number of sites** 46 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **Lead sponsor** Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) ## Identifiers **Registry ID** NCT07112872 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **ClinicalTrials.gov ID** NCT07112872 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) ## Outcomes ### Primary outcomes 1. RO7795081 vs. Placebo: Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 30 Timeframe: Baseline to Week 30 ### Secondary outcomes 1. RO7795081 vs. Semaglutide (Part A): Change in HbA1c from Baseline at Week 30 Timeframe: Baseline to Week 30 2. Percentage of Participants with HbA1c <5.7%, ≤6.5%, and <7.0% at Week 30 Timeframe: Week 30 3. Change in Fasting Plasma Glucose from Baseline at Week 30 Timeframe: Baseline to Week 30 4. Percent Change in Body Weight from Baseline at Week 30 Timeframe: Baseline to Week 30 5. Absolute Change in Body Weight (kg) from Baseline at Week 30 Timeframe: Baseline to Week 30 6. Percentage of Participants Who Achieve ≥5%, ≥10%, or ≥15% Body Weight Reduction from Baseline at Week 30 Timeframe: Baseline and Week 30 7. Incidence of Adverse Events (AEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) Timeframe: From first dose until 28 days after the final dose of study treatment (34 weeks) 8. Number of Participants with Documented Hypoglycemia (Level 1, 2, or 3 per American Diabetes Association 2025) Timeframe: From first dose until 28 days after the final dose of study treatment (34 weeks) 9. Plasma Concentrations of RO7795081 at Prespecified Timepoints Timeframe: Predose on Day 1 and at prespecified timepoints until Week 30 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) ## Sites - Arizona Liver Health - TucsonTucson, United States - Orange County Research CenterLake Forest, United States - Prospective Research Innovations Inc.Rancho Cucamonga, United States - Encompass Clinical ResearchSpring Valley, United States - Chase Medical ResearchWaterbury, United States - Emerson Clinical Research InstituteWashington D.C., United States - K2 Medical Research South Orlando, LLCClermont, United States - Center for Diabetes, Obesity and Metabolism IncPembroke Pines, United States - Rophe Adult and Pediatric Medicine/SKYCRNGUnion City, United States - Accellacare of Duly Health and CareOak Lawn, United States - Neurobehavioral Research, Inc.Cedarhurst, United States - Accellacare of Piedmont HealthcareStatesville, United States - Accellacare of Wilmington, LLCWilmington, United States - NexGen ResearchLima, United States - Tristar Clinical InvestigationsPhiladelphia, United States - Clinical Research AssociatesNashville, United States - Texas Diabetes & Endocrinology, P.A.Austin, United States - Apex Mobile Clinical ResearchBellaire, United States - Velocity Clinical ResearchDallas, United States - Chrysalis Clinical ResearchSt. George, United States - Manassas Clinical Research CenterManassas, United States - Obudai Egeszsegugyi Centrum Kft.Budapest, Hungary - NZOZ Osteo-Medic s.c. A. Racewicz, J.SupronikBialystok, Poland - Centrum Badan Klinicznych PI-House sp. z o.o.Gdansk, Poland - Centrum Medyczne INTERCOR Sp. z o.o.Bydgoszcz, Poland And 21 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) ## References - Related resource (www.gene.com) Source: [www.gene.com](https://www.gene.com/contact-us/submit-medical-inquiry) ### Other registry identifiers - 2024-520322-11-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112872) ## Related records ### Drugs (1) - [Semaglutide](https://trialight.com/data/asset/semaglutide-0f0980aa-d386-4209-8f14-80da83c40d80.md) ### Lead sponsors (1) - [Hoffmann-La Roche](https://trialight.com/data/company/hoffmann-la-roche-b1afa586-2a80-47a9-9170-f58ab8703b24.md) ### Conditions (1) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Primary condition ### Targets (1) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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