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

Study acronym: RENEW-MDD- 2
StatusRecruiting
PhasePhase 3
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 169 to 170
  2. Recruitment opened Show 4 more changesShow less
    • Start date changed from estimate of Aug 2026 to Aug 14, 2026
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 2 of 11 entries
    • Study sites revised (169)
  3. Study Status, Referencesv2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Eli Lilly
363 trials monitored
See 16 trials at risk
Depression
3,069 trials monitored
See 170 trials at risk
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.
Trial Details
NCT Number NCT07775300
Lead Sponsor Eli Lilly and Company
Conditions
(from sponsor)		 Depressive Disorder, Major
Related terms Depression, Depressive Disorder, Major Depressive Disorder, Mood Disorders
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov