Study of Brenipatide (LY3537031) in Adults with Major Depressive Disorder to Evaluate Delay of Relapse Compared with Placebo

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What is this study about?

The study focuses on adults with Major Depressive Disorder, a condition marked by persistent low mood, loss of interest, and difficulty carrying out daily activities. Participants will keep taking their regular antidepressant medication and will receive either the investigational drug Brenipatide (code name LY3537031) or a matching placebo. The purpose of the study is to determine whether adding this medication can delay the time it takes for depressive symptoms to return.

People who join the trial will be assigned by chance (randomized) to one of the two groups, and neither the participants nor the study staff will know which treatment is being given (double‑blind). The medication is given as a small injection under the skin (subcutaneous) using a pre‑filled syringe. After the first dose, participants will attend regular clinic visits for several weeks to monitor safety and track any changes in mood. The study will continue until enough participants have experienced a return of symptoms (relapse) to allow comparison of the two groups.

Who Can Join the Study?

  • Must be taking a stable standard of care medication that is the usual treatment for major depressive disorder (a type of depression).
  • Must be able to stay in the study for its entire length, attend all required visits, and follow the study instructions.
  • Must be willing and able to self‑inject the study medication (give yourself a shot).
  • Must be able to store and use the study medication as directed, even though you will not know whether it is the active drug or a placebo (blinded).
  • Must keep electronic or paper diaries and fill out the required questionnaires as asked.
  • Must be a man or woman who meets the study’s age requirements for adult participants.

Who Cannot Join the Study?

  • Has ever been diagnosed with or currently has schizophrenia spectrum or other psychotic disorder (serious mental illness that can cause hallucinations or loss of touch with reality), bipolar disorder (extreme mood swings), borderline personality disorder (unstable emotions and relationships), or any eating disorder (abnormal eating habits).
  • Has type 1 diabetes mellitus (a condition where the body cannot produce insulin) or a past history of ketoacidosis (dangerously high acid levels in the blood), hyperosmolar state (very high blood sugar causing severe dehydration), or a coma (loss of consciousness).
  • Shows evidence of a moderate or severe substance or alcohol use disorder (problematic use of drugs or alcohol) within the last 180 days.
  • Is currently suicidal or considered to be at a significant risk for suicide.
  • Has taken part in another clinical study and received an active medication, or it is unknown whether an active medication was taken, within the past 90 days or five drug half‑lives (the time it takes for half of a drug to leave the body), whichever period is longer.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Salamanca Salamanca Spain
Pharmakologisches Studienzentrum Chemnitz GmbH Chemnitz Germany
Praktyka Lekarska Małgorzata Wojtanowska-Bogacka Poznan Poland
Diamond Clinic Sp. z o.o. Cracow Poland
ClinHouse Centrum Medyczne Zabrze Poland

Other Sites

Site Name City Country Status
Pan-Arcadian General Hospital Of Tripoli Evangelistria Tripoli Greece
Hospital Del Mar Barcelona Spain
Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbH Schwerin Germany
In Vivo Sp. z o.o. Bydgoszcz Poland
Nowy Szpital W Olkuszu Sp. z o.o. Olkusz Poland
MentalMEDIC Grzegorz Giemza, Gliwickie Centrum Psychiatrii i Psychoterapii Bielsko-Biala Poland
NZOP Mentis Leszno Poland
Sjyfcvpcsmpv Goyjkqg Hokukovc Athens Greece
Ujiucpuoiw Gtumcus Htvosnzn Ov Ithftbkv Ioannina Greece
Gdecubb Hcyglnvt Ol Ttxhsxqlqohz Pdfqavelpsbf Thessaloniki Greece
Upwdhritwb Gdpdkjr Hkegzkdd Absbvlt Ggssuwk Hpnsvywe Oy Wkqj Ayneep H Afwp Vrscixd Chaidari Greece
Afzuazwe Gxsrqzj Hegiepda Argos-Mykines Greece
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Heyhze Pjauv Sszg Barcelona Spain
Fudqggbvha Gqym Offenbach Am Main Germany
Vaveor dof Rodys Uaxcpszfbr Hfjiiydf Sevilla Spain
Cfavrzt Uwbotauzkaoywskzsndt Bnimgk Ksj Berlin Germany
Poiy Szzdzcut Sigd Jjme Dw Dbr Sant Boi De Llobregat Spain
Ulqogmtislie Lyxqrwp Leipzig Germany
Hqwndeav Dz Lz Sjnmd Cqbp I Stus Pfy Barcelona Spain
Hpegefmg Uvwfpjohwcnkn Ittgczg Lonubk Madrid Spain
Ksohojmdr Ficpnfnqs Hdjatto Gotg Hamburg Germany
Euc Okzbk Sne Afk Ccsixpj Sutcmm Centelles Spain
Hveszorr Cdrbci dr Bvnqmjddf Barcelona Spain
Hhflvmgc Pbxdzjfjwn du Zjzfvr Zamora Spain
Sgmgvwre di Sngzi Mehmoo djg Áset Ix Cmx Lh Cwyaurhvox Oyrhon Oviedo Spain
Gtqelkynva Rotaghqv Sxp z orfa Wroclaw Poland
Sqocg Sjp z obho Lodz Poland
Cexhavj Bpofp Ktnuwhhivnh Priqbowr Smo z opza Gdansk Poland
Ribzt Sab z oszi Bialystok Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not yet recruiting
15.07.2026
Greece Greece
Not yet recruiting
15.07.2026
Poland Poland
Not yet recruiting
15.07.2026
Spain Spain
Not yet recruiting
15.07.2026

Trial locations

Investigated Drugs:

Brenipatide is an experimental medication being tested as an additional (adjunctive) treatment for adults with major depressive disorder. In the study, it is given as a small amount of liquid that is injected under the skin (subcutaneous injection). The goal of adding Brenipatide to participants’ regular antidepressant medicines is to see if it can help keep their depression from returning for a longer time compared with a placebo.

Major Depressive Disorder – Major Depressive Disorder is a mental health condition marked by persistent low mood, loss of interest, and changes in sleep, appetite, and energy lasting at least two weeks. It can begin at any age, often emerging in adolescence or early adulthood. Without improvement, symptoms may intensify, making daily tasks, work, and relationships increasingly difficult. The illness often follows a pattern of episodes that can improve and then return. Over time, episodes may become more frequent or last longer, and some individuals experience chronic symptoms that persist for months or years. Periods of partial or full remission may alternate with new episodes.

Trial ID:
2025-522310-24-00
Protocol code:
J2S-MC-GZMI
Trial Phase:
Therapeutic confirmatory (Phase III)

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