Gyminda
Research type
Research Study
Full title
A Randomised, Double-Blind, Placebo-Controlled Phase 2 Trial to Assess Efficacy, Safety And Tolerability of RO7204239 in combination with Tirzepatide in participants with obesity or overweight with at least one weight related comorbidity.
IRAS ID
1011579
Contact name
Lynsey Kennedy
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2024-519561-22
Research summary
This study is researching a drug called RO7204239, that is being developed for the possible treatment of obesity or being overweight with one weight related conditions but without diabetes mellitus. Tirzepatide is one of the standard therapy that is currently used to treat these patients. The aim of the study is to compare the effects of RO7204239 plus tirzepatide versus tirzepatide alone (i.e., with a placebo). The treatment group participants are in will be decided upon by chance. The study has four periods: 1. Screening period of up to 4 weeks 2. Core treatment period of 48 weeks 3. Extension treatment period of 24 weeks 4. Follow up period of 24 weeks.
The study will include approximately 234 people.
The length of participation in this study will be around 2 years.
Study procedures will include: Physical examinations, Electrocardiogram (ECGs), Magnetic resonance imaging (MRI) scan, Dual energy x ray (DXA) scan, blood and urine tests and completion of questionnaires.REC name
South Central - Berkshire Research Ethics Committee
REC reference
25/SC/0129
Date of REC Opinion
4 Jun 2025
REC opinion
Further Information Favourable Opinion