NCT07412756: RENEW-MDD-1

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)

Recruiting now Phase 3 Last updated 19 March 2026

What this trial tests

Phase 3 trial testing Brenipatide in Depressive Disorder, Major in 1,000 participants. Currently enrolling.

Timeline

9 February 2026

Primary endpoint
1 February 2028

1 February 2028

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,000
Start date	9 February 2026
Primary completion	1 February 2028
Estimated completion	1 February 2028
Sites	186 locations across United States, Australia, Brazil, Canada, China, Germany, Greece, Japan

Drugs / interventions tested

• Brenipatide — full drug profile →
• Placebo

Conditions studied

• Depressive Disorder, Major — all drugs for Depressive Disorder, Major →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 75, any sex, with Depressive Disorder, Major. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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)
  Time frame: From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Acute Contractile Effects of Glucagon-like-Peptide-1 Receptor Agonists in the Human Heart.
   Neumann J, Kirchhefer U, Hofmann B, Gergs U. · · 2026 · PMID 42076099 · DOI 10.3390/pharmaceutics18040447