NCT07351045

A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight Without Type 2 Diabetes

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight Without Type 2 Diabetes

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of RO7795068, a dual glucagon like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.

Conditions

• Obesity or Overweight

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Placebo	Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.
COMBINATION_PRODUCT	RO7795068	RO7795068 will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.

Timeline

• Start date: 2026-03-16
• Primary completion: 2028-07-24
• Completion: 2028-08-28
• First posted: 2026-01-20
• Last updated: 2026-04-07

Locations

22 sites across 5 countries: United States, Australia, Canada, Japan, Taiwan

Regulatory

• FDA-regulated drug study