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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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).

Key facts

Study ID

NCT07112872

Run by

Hoffmann-La Roche

People needed

240

Starts

2025-08-19

Expected to finish

2026-11-27

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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
• Obudai Egeszsegugyi Centrum Kft. — Budapest, Hungary

Full record on ClinicalTrials.gov

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