Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07775300 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder

Study acronym: RENEW-MDD- 2
StatusNot Yet Recruiting
PhasePhase 3
Started2026-08
View on ClinicalTrials.gov ↗
This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms. The trial is divided into three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.

Amendment record

Amended once since 2026-08-14. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-08-25
Amendment Study Status, References v1
2026-08-14
Original filing
Trial Details
NCT Number NCT07775300
Lead Sponsor Eli Lilly and Company
Conditions Depressive Disorder, Major
Enrollment 1,000 participants
Start Date 2026-08
Primary Completion 2028-12 (estimated)
Study Completion 2029-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-27