NCT07351058

A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and 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 and Type 2 Diabetes

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,600 (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 with obesity or overweight and Type 2 diabetes mellitus (T2DM).

Conditions

• Obesity or Overweight
• Type 2 Diabetes Mellitus

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: 2026-03-23
• Primary completion: 2028-08-07
• Completion: 2028-08-07
• First posted: 2026-01-20
• Last updated: 2026-04-14

Locations

28 sites across 6 countries: United States, Australia, Canada, Japan, Taiwan, Thailand

Regulatory

• FDA-regulated drug study