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HomeTrials › NCT07112872

Type 2 diabetes · Phase 2 · Active, not recruiting

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

NCT07112872 · Sponsor: Hoffmann-La Roche

What this trial means for you

This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying RO7795081, Semaglutide, Placebo for type 2 diabetes mellitus.

Who can joinAll sexes, 18 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeRO7795081, Semaglutide, Placebo
Study length~15 months overall
Planned participants240
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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).

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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 sites by state

Arizona

  • Arizona Liver Health - Tucson — Tucson

California

  • Orange County Research Center — Lake Forest
  • Prospective Research Innovations Inc. — Rancho Cucamonga
  • Encompass Clinical Research — Spring Valley

Connecticut

  • Chase Medical Research — Waterbury

District of Columbia

  • Emerson Clinical Research Institute — Washington D.C.

Florida

  • K2 Medical Research South Orlando, LLC — Clermont
  • Center for Diabetes, Obesity and Metabolism Inc — Pembroke Pines

Georgia

  • Rophe Adult and Pediatric Medicine/SKYCRNG — Union City

Illinois

  • Accellacare of Duly Health and Care — Oak Lawn

Montana

  • Mercury Street Medical Group, PLLC — Butte

New York

  • Neurobehavioral Research, Inc. — Cedarhurst

North Carolina

  • Accellacare of Piedmont Healthcare — Statesville
  • Accellacare of Wilmington, LLC — Wilmington

Ohio

  • NexGen Research — Lima

Pennsylvania

  • Tristar Clinical Investigations — Philadelphia

Tennessee

  • Alliance for Multispecialty Research. LLC — Knoxville
  • Clinical Research Associates — Nashville

Texas

  • Texas Diabetes & Endocrinology, P.A. — Austin
  • Apex Mobile Clinical Research — Bellaire
  • Velocity Clinical Research — Dallas
  • Velocity Clinical Research (Impact Research Institute) — Waco

Utah

  • Chrysalis Clinical Research — St. George

Virginia

  • Manassas Clinical Research Center — Manassas

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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