DRUG
RO7795081
RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
Status
Active, not recruiting
Phase
Phase 2
Enrollment
240
Locations
50
Results
Not posted
Publications
0
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).
Interventions
DRUG
RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
DRUG
Semaglutide 14 mg will be taken orally QD, with up-titration as per label, during the 30-week treatment period.
DRUG
Placebo will be taken orally QD during the 30-week treatment period.
Timeline
First posted
Aug 8, 2025
Study start
Aug 19, 2025
Primary completion
Nov 27, 2026
Study completion
Nov 27, 2026
Results posted
Not reported
Registry updated
Jul 7, 2026
Outcomes
RO7795081 vs. Placebo: Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 30
Time frame · Baseline to Week 30
RO7795081 vs. Semaglutide: Change in HbA1c from Baseline at Week 30
Time frame · Baseline to Week 30
Percentage of Participants with HbA1c <5.7%, ≤6.5%, and <7.0% at Week 30
Time frame · Week 30
Change in Fasting Plasma Glucose from Baseline at Week 30
Time frame · Baseline to Week 30
Percent Change in Body Weight from Baseline at Week 30
Time frame · Baseline to Week 30
Absolute Change in Body Weight (kg) from Baseline at Week 30
Time frame · Baseline to Week 30
Percentage of Participants Who Achieve ≥5%, ≥10%, or ≥15% Body Weight Reduction from Baseline at Week 30
Time frame · Baseline and Week 30
Incidence of Adverse Events (AEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)
Time frame · 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)
Time frame · From first dose until 28 days after the final dose of study treatment (34 weeks)
Plasma Concentrations of RO7795081 at Prespecified Timepoints
Time frame · Predose on Day 1 and at prespecified timepoints until Week 30
Eligibility
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
Study locations
Hungary · Poland · Spain · United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
No PMID-linked publications were present in this registry snapshot.
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