RecruitingPhase 3

A Study of Brenipatide in Adult Participants With Major Depressive Disorder

United States, Australia, Brazil1,000 participantsStarted 2026-02-09

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Meet the diagnostic criteria for major depressive disorder * Are on a stable standard of care medication for major depressive disorder * Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as * self-inject study intervention * store and use the provided blinded study intervention, as directed * maintain electronic and paper study diaries, as applicable, and * complete the required questionnaires Exclusion Criteria: * Have a lifetime history or current diagnosis of the following: * schizophrenia or other psychotic disorder * bipolar disorder * borderline personality disorder, or * any eating disorder. * Have type 1 diabetes mellitus, or a history of * ketoacidosis, or * hyperosmolar state or coma. * Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening * Are actively suicidal or deemed a significant risk for suicide * Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a Phase 3 trial measuring how long it takes for major depression to come back after treatment, does that mean I would first need to respond to brenipatide before being randomized — and what happens if I don't respond in that initial phase?
2Because the main thing this study is tracking is 'time to relapse,' does that mean I might be switched to a placebo or lower-dose arm at some point, and how would my depression be monitored and managed if my symptoms returned during the trial?
3How does brenipatide compare to antidepressants I might already be eligible for, and is it worth trying an established treatment first before joining a study like this?
4What would my commitment look like day-to-day — how many visits, how long would I be in the study, and is the schedule realistic given my work or family situation?
5Given that this is a relapse-prevention study, what criteria does the trial use to define a 'relapse,' and would I be able to get immediate treatment if I met those criteria while enrolled?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

Timeframe: From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months

Trial details

NCT IDNCT07412756

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-02

Contact for this trial

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559 LillyTrials@Lilly.com

View on ClinicalTrials.gov More Depressive Disorder, Major trials