J2S-MC-GZMH
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment with Brenipatide in Delaying Time to Relapse Compared with Placebo in Adult Participants with Major Depressive Disorder (RENEW-MDD-1).
IRAS ID
1012866
Contact name
Tetiana Rudenok
Contact email
Sponsor organisation
Eli Lilly and Company
Research summary
The purpose of this study is to assess the efficacy and safety of brenipatide compared with placebo in participants with major depressive disorder (MDD). The results from this study will help researchers to decide on how to continue developing brenipatide in the future. This study includes the following study periods:
· screening period
· treatment period and
· post treatment safety follow-up period.
The study will enroll participants from 18 to 75 years of age (inclusive) with MDD. Study participants will be excluded based on conditions that could interfere with study assessments or increase a participant’s risk of experiencing side effects during the study. Approximately 1000 participants will be randomly assigned to the study drug or placebo.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
25/EM/0230
Date of REC Opinion
17 Nov 2025
REC opinion
Further Information Favourable Opinion