A Study to Compare Different Doses of RO7795081 With a Placebo or Semaglutide in People With Type 2 Diabetes
Not Applicable
Recruiting
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT07112872
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Placebo Placebo - Arm 2: Semaglutide 14 mg Semaglutide - Arm 3: RO7795081 Dosing Regimen 1 RO7795081 - Arm 5: RO7795081 Dosing Regimen 3 RO7795081 - Arm 6: RO7795081 Dosing Regimen 4 RO7795081 - Arm 4: RO7795081 Dosing Regimen 2 RO7795081 - Arm 7: RO7795081 Dosing Regimen 5 RO7795081 - Arm 8: RO7795081 Dosing Regimen 6 RO7795081 - Arm 9: RO7795081 Dosing Regimen 7 RO7795081 -
- Primary Outcome Measures
Name Time Method RO7795081 vs. Placebo: Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 30 Baseline to Week 30
- Secondary Outcome Measures
Name Time Method RO7795081 vs. Semaglutide: Change in HbA1c from Baseline at Week 30 Baseline to Week 30 Change in Fasting Plasma Glucose from Baseline at Week 30 Baseline to Week 30 Percentage of Participants with HbA1c <5.7%, ≤6.5%, and <7.0% at Week 30 Week 30 Percent Change in Body Weight from Baseline at Week 30 Baseline to Week 30 Absolute Change in Body Weight (kg) from Baseline at Week 30 Baseline to Week 30 Percentage of Participants Who Achieve ≥5%, ≥10%, or ≥15% Body Weight Reduction from Baseline at Week 30 Baseline and Week 30 Incidence of Adverse Events (AEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) 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 2024) From first dose until 28 days after the final dose of study treatment (34 weeks) Plasma Concentrations of RO7795081 at Prespecified Timepoints Predose on Day 1 and at prespecified timepoints until Week 30
Trial Locations
- Locations (6)
Emerson Clinical Research Institute
🇺🇸Washington, District of Columbia, United States
Mercury Street Medical Group, PLLC
🇺🇸Butte, Montana, United States
Tristar Clinical Investigations
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Research Associates
🇺🇸Nashville, Tennessee, United States
Texas Diabetes & Endocrinology, P.A.
🇺🇸Austin, Texas, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
Emerson Clinical Research Institute🇺🇸Washington, District of Columbia, United States