NCT07081958

A Study Evaluating the Effect of Daily Oral RO7795081 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Daily RO7795081 Administered for 38 Weeks to Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-range-finding, Phase II study aims to evaluate the efficacy, tolerability, and safety of RO7795081 for chronic weight management in adult participants with obesity or overweight with at least one weight-related comorbidity, but without diabetes mellitus.

Conditions

• Obesity or Overweight

Interventions

Type	Name	Description
DRUG	RO7795081	RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period.
DRUG	Placebo	Placebo matching each RO7795081 dosing regimen arm will be administered orally once daily during the 38-week treatment period.

Timeline

• Start date: 2025-07-29
• Primary completion: 2026-04-23
• Completion: 2026-07-17
• First posted: 2025-07-24
• Last updated: 2026-04-14

Locations

36 sites across 1 country: United States

Regulatory

• FDA-regulated drug study