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?

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Verified Sites

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Other Sites

Site Name	City	Country
Pan-Arcadian General Hospital Of Tripoli Evangelistria	Tripoli	Greece
Sauujbnyhzrj Gfytwex Hhwalfpn	Athens	Greece
Uujbotdagp Gzlmubd Hekdxjlm Op Iknqhwqh	Ioannina	Greece
Gyuouty Hkdiodit Od Tucolugoexdi Pzowyafxzquf	Thessaloniki	Greece
Uhnjevjboy Gmbisxj Hgptkjgs Ahwgbua Gmakrhj Hrhrjphh Ow Wsqz Aarlfe H Auns Vlxzmms	Chaidari	Greece
Aspeilao Gzulgmr Hhavkgan	Argos-Mykines	Greece
Mzlsvipejysvawxgo Mabank Hgysnm Hfzviysv oc Apzzed	Chaidari	Greece

Trial status

Country	Status	Recruitment Start
Greece	Not yet recruiting	15.07.2026

Trial locations

Investigated Drugs:

LY3537031

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?