NCT07112872

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

A Randomized, Double-Blind, Placebo- and Open-Label Active Comparator- Controlled, Parallel-Group, Multi-Center Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Daily RO7795081 Administered for 30 Weeks to Participants With Type 2 Diabetes Mellitus

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	RO7795081	RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
DRUG	Semaglutide	Semaglutide 14 mg will be taken orally QD, with up-titration as per label, during the 30-week treatment period.
DRUG	Placebo	Placebo will be taken orally QD during the 30-week treatment period.

Timeline

• Start date: 2025-08-19
• Primary completion: 2026-11-27
• Completion: 2026-11-27
• First posted: 2025-08-08
• Last updated: 2026-04-08

Locations

50 sites across 4 countries: United States, Hungary, Poland, Spain

Regulatory

• FDA-regulated drug study