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Depressive Disorder, MajorMental healthDrugPhase 3

What this study is

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 four periods as follows: a screening period that will last approximately 1 month, a treatment period with a potential post treatment period that combined will last a minimum of 12 months, and the follow up period that will last approximately 2 months.

What's being tested

  • Brenipatide

    Intervention · DRUG

  • Placebo

    Intervention · DRUG

Both interventions

Administered SC

Study details

Official 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)
Sponsor
Eli Lilly and Company
Conditions
Depressive Disorder, Major
Enrolling
1,000 people
Starts
2026-02-09
Est. completion
2028-02
Design
Double-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗