A Study of Brenipatide in Adult Participants With Major Depressive Disorder

This is a registry record, not a result. A trial being listed, recruiting or completed says nothing by itself about whether the compound works or is safe.

Registry numberNCT07412756
StatusRecruiting
PhasePhase 3
SponsorEli Lilly and Company
Enrollment1,000 participants
DesignInterventional, Randomized, Parallel, Masking: Double
ConditionsDepressive Disorder, Major
InterventionsBrenipatide; Placebo
StartFeb 9, 2026
Primary completionFeb 2028
Study completionFeb 2028
Results postedNot yet
Registry last updatedAug 6, 2026

Compounds on this site that cite this trial

What the registry says the trial is about

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.

Primary outcomes

These are what the trial was designed to measure first. They are registered in advance, which is what makes a later result checkable.

Outcome measureTime frame
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)From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months

11 secondary outcomes also registered. See the registry record for the full list.

Source: ClinicalTrials.gov (U.S. National Library of Medicine). Last checked against the registry on Oct 3, 2026. See the trial changes feed for what has changed recently.