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Clinical Trials in the EU / 2025-522310-24-00
Authorised Phase III

JS2-MC-GZMI: 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- 2)

2025-522310-24-00 · tracked via the Priya Life Science EU tracker
Sponsor
Eli Lilly & Co.
Sponsor type
Pharmaceutical company
Therapeutic area
Mental Disorders
Decision date
19/08/2026
Enrollment target
228
Sites
Poland, Greece, Spain, Germany

Condition studied

Depressive Disorder, Major

Investigational medicinal product(s)

BrenipatidePlacebo to match LYBrenipatideBrenipatide

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

Time to Relapse Defined as the Number of Days from Randomization to Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD)

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-522310-24-00 on CTIS ↗ ← All trials in the EU