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

NCT07112872

Active Not RecruitingPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Type 2 Diabetes Mellitus

Interventions: RO7795081, Semaglutide, Placebo

Countries: United States, Hungary, Poland, Spain

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (50)
  • Tucson, Arizona, United States
  • Lake Forest, California, United States
  • Rancho Cucamonga, California, United States
  • Spring Valley, California, United States
  • Waterbury, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Clermont, Florida, United States
  • Pembroke Pines, Florida, United States
  • Union City, Georgia, United States
  • Oak Lawn, Illinois, United States
  • Butte, Montana, United States
  • Cedarhurst, New York, United States
  • Statesville, North Carolina, United States
  • Wilmington, North Carolina, United States
  • Lima, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Knoxville, Tennessee, United States
  • Nashville, Tennessee, United States
  • Austin, Texas, United States
  • Bellaire, Texas, United States
  • Dallas, Texas, United States
  • Waco, Texas, United States
  • St. George, Utah, United States
  • Manassas, Virginia, United States
  • Budapest, Hungary
  • Bialystok, Podlaskie Voivodeship, Poland
  • Gdansk, Pomeranian Voivodeship, Poland
  • Bydgoszcz, Poland
  • Katowice, Poland
  • Lublin, Poland
  • + 20 more on CT.gov