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Brenipatide added to standard antidepressant treatment for adults with major depression

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)

Phase 3 Interventional Eli Lilly and Company · NCT07412756

This trial will see if adding brenipatide to your current antidepressant treatment can delay the return of major depressive symptoms in adults with major depressive disorder.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1000 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations186 sites (Moorpark, California and 185 other locations)
Trial IDNCT07412756 on ClinicalTrials.gov

What this trial studies

Adults who meet diagnostic criteria for major depressive disorder and are on a stable standard-of-care medication will receive either brenipatide plus their usual treatment or a matching placebo plus their usual treatment under blinded conditions. Participation begins with a screening period of about one month, followed by a minimum 12-month treatment period and approximately a two-month follow-up. Participants will self-administer the blinded injection, keep electronic and paper diaries as instructed, and complete scheduled questionnaires and clinic visits. The study will collect safety and efficacy data focused on delaying recurrence of major depressive symptoms while monitoring adverse events.

Who should consider this trial

Good fit: Adults with a diagnosis of major depressive disorder who are on a stable standard-of-care antidepressant regimen and are willing and able to self-inject and attend required visits and complete study diaries and questionnaires.

Not a fit: People with a history of schizophrenia, bipolar disorder, borderline personality disorder, eating disorders, type 1 diabetes, recent moderate-to-severe substance or alcohol use disorder, or those not on a stable standard-of-care antidepressant or unwilling to comply with study procedures are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, brenipatide could help people on antidepressants stay well longer by delaying the return of major depressive symptoms.

How similar studies have performed: Earlier-phase trials and similar adjunctive medication approaches have shown encouraging signals but require confirmation in larger Phase 3 programs, so this Phase 3 effort aims to provide definitive evidence.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Moorpark, California and 185 other locations

+136 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Depressive Disorder, MajorMajor Depressive EpisodeMood DisordersDepressionDepressive Disorder
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.