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Taking people in Puerto RicoPhase 3

Brenipatide added to usual care to delay return of major depression

Tests brenipatide alongside usual care in adults with major depressive disorder.

Key facts

Who runs it
Eli Lilly and Company
Where
San Juan, Puerto RicoSee the 3 sitesAlso in 14 other countries, 167 sites
Trial code
Registry title
A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
Status
Recruiting
Phase
Phase 3
People taking part
1,000 people, planned
Started
14 Aug 2026
Expected to end
Feb 2029
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Brenipatide
  • Placebo
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 75 with major depression who already take a stable standard medicine for it. It tests brenipatide against placebo for delaying a return of depression.

Age
18 to 75 years
Sex
All sexes
Disease stage
Major depressive disorder, on stable standard of care medication
Earlier treatment
Must be on stable standard of care medication for major depressive disorder. Must not have had active treatment in another clinical study within 90 days or 5 half-lives (whichever is longer) before screening.

Main reasons for not taking part

  • Schizophrenia spectrum or other psychotic disorder, bipolar disorder, borderline personality disorder or any eating disorder (lifetime or current)
  • Type 1 diabetes, or a history of ketoacidosis or hyperosmolar state or coma
  • Moderate or severe substance or alcohol use disorder within 180 days of screening
  • Actively suicidal or a significant suicide risk
  • Active treatment in another clinical study within 90 days or 5 half-lives before screening

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • Meet the diagnostic criteria for major depressive disorder
  • Are on 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

Who cannot take part

  • 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
  • Have a lifetime history or current diagnosis of the following:; schizophrenia spectrum 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in Puerto Rico

Also in 14 other countries, 167 sites

  • Barbara Diaz Hernandez MD Research IncSan Juan, Puerto RicoContact: Ileana Fumero-Perez (principal investigator)Not yet recruiting
  • INSPIRA Clinical ResearchSan Juan, Puerto RicoContact: Yvette Cruz-Pagan (principal investigator)Taking people
  • Instituto De Neurologia Dra. Ivonne FragaSan Juan, Puerto RicoContact: Ivonne Fraga Berrios (principal investigator)Not yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

The trial is divided into four periods as follows: a screening period that will last approximately 1 month, a treatment period and a post- treatment period that combined will last a minimum of 12 months, and the safety 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.

The 4 groups in the trial

  • Brenipatide Dose 1Treatment being tested

    Brenipatide administered subcutaneous (SC) + standard of care (SoC).

    Treatment: Brenipatide

  • Brenipatide Dose 2Treatment being tested

    Brenipatide administered SC + SoC.

    Treatment: Brenipatide

  • Brenipatide Dose 3Treatment being tested

    Brenipatide administered SC + SoC.

    Treatment: Brenipatide

  • PlaceboPlacebo, for comparison

    Placebo administered SC + SoC.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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- 2)
Plain-language title
Brenipatide added to usual care to delay return of major depressionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07775300, who can take part
Record updated
3 November 2026