NCT07412756

A Study of Brenipatide in Adult Participants With Major Depressive Disorder

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Brenipatide	Administered SC
DRUG	Placebo	Administered SC

Timeline

• Start date: 2026-02-09
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2026-02-17
• Last updated: 2026-03-23

Locations

186 sites across 15 countries: United States, Australia, Brazil, Canada, China, Germany, Greece, Japan, Mexico, Poland, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study