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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
Semaglutide 14 mg will be taken orally QD, with up-titration as per label, during the 30-week treatment period.
Placebo will be taken orally QD during the 30-week treatment period.
RO7795081 vs. Placebo: Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 30
Time frame: Baseline to Week 30
RO7795081 vs. Semaglutide: Change in HbA1c from Baseline at Week 30
Time frame: Baseline to Week 30
Percentage of Participants with HbA1c <5.7%, ≤6.5%, and <7.0% at Week 30
Time frame: Week 30
Change in Fasting Plasma Glucose from Baseline at Week 30
Time frame: Baseline to Week 30
Percent Change in Body Weight from Baseline at Week 30
Time frame: Baseline to Week 30
Absolute Change in Body Weight (kg) from Baseline at Week 30
Time frame: Baseline to Week 30
Percentage of Participants Who Achieve ≥5%, ≥10%, or ≥15% Body Weight Reduction from Baseline at Week 30
Time frame: Baseline and Week 30
Incidence of Adverse Events (AEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)
Time frame: 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)
Time frame: From first dose until 28 days after the final dose of study treatment (34 weeks)
Plasma Concentrations of RO7795081 at Prespecified Timepoints
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Time frame: Predose on Day 1 and at prespecified timepoints until Week 30