A Study to Compare Different Doses of RO7795081 With Placebo or Semaglutide in People With Type 2 Diabetes
NCT07112872
Phase
Phase 2
Recruitment status
Active, not recruiting
Participants
Lead sponsor
Hoffmann-La Roche
Start date
2025-08-19
Number of sites
- 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).
- Short title
- A Study to Compare Different Doses of RO7795081 With Placebo or Semaglutide in People With Type 2 Diabetes
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2028-02-05
- First posted
- 2025-08-08
- Registry last updated
- 2026-10-01
- Primary completion date
- 2028-02-05
- Start date
- 2025-08-19
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Hoffmann-La Roche
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07112872
- ClinicalTrials.gov ID
- NCT07112872
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Sources for study design
RO7795081 vs. Placebo: Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 30
Timeframe: Baseline to Week 30
RO7795081 vs. Semaglutide (Part A): Change in HbA1c from Baseline at Week 30
Timeframe: Baseline to Week 30
Percentage of Participants with HbA1c <5.7%, ≤6.5%, and <7.0% at Week 30
Timeframe: Week 30
Change in Fasting Plasma Glucose from Baseline at Week 30
Timeframe: Baseline to Week 30
Percent Change in Body Weight from Baseline at Week 30
Timeframe: Baseline to Week 30
Absolute Change in Body Weight (kg) from Baseline at Week 30
Timeframe: Baseline to Week 30
Percentage of Participants Who Achieve ≥5%, ≥10%, or ≥15% Body Weight Reduction from Baseline at Week 30
Timeframe: Baseline and Week 30
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)
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)
Plasma Concentrations of RO7795081 at Prespecified Timepoints
Timeframe: Predose on Day 1 and at prespecified timepoints until Week 30
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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)
- 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
- 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
- Related resource (www.gene.com)
Other registry identifiers
- 2024-520322-11-00
Sources for references
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Type 2 diabetes mellitus Primary condition