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.
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 →
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