Type 2 Diabetes Mellitus
Conditions
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).
Interventions
DRUGRO7795081
RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
DRUGSemaglutide
Semaglutide 14 mg will be taken orally QD, with up-titration as per label, during the 30-week treatment period.
DRUGPlacebo
Placebo will be taken orally QD during the 30-week treatment period.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RO7795081 vs. Placebo: Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 30 | Baseline to Week 30 |
Secondary
| Measure | Time frame |
|---|---|
| RO7795081 vs. Semaglutide: Change in HbA1c 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 |
| Change in Fasting Plasma Glucose from Baseline at Week 30 | Baseline to 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 2025) | 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 |
Countries
Hungary, Poland, Spain, United States
Contacts
CONTACTReference Study ID Number: BP45703 https://forpatients.roche.com/
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed