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

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization
After joining the study, you will be assigned by the study team to receive either Brenipatide or a matching placebo. This assignment is done randomly, so neither you nor the study staff will know which product you receive.
The randomization occurs on the first day of the study, marking the start of all subsequent procedures.
Step 2
Baseline assessments
Before any medication is given, you will complete a series of questionnaires and clinical evaluations to record the current severity of your major depressive disorder and to document any other health information.
These baseline measurements serve as a reference point for later comparisons.
Step 3
Initiation of study medication
On the day after randomization, you will begin receiving the study medication. The product is provided as a solution for injection in a pre‑filled syringe intended for subcutaneous use (injection under the skin).
You will continue taking your regular, stable standard‑of‑care (SoC) antidepressant medication alongside the study product, as directed by your physician.
Step 4
Regular dosing schedule
The study medication (or placebo) will be administered by injection at the frequency specified in the study protocol. Each dose is given in the same manner as the initial injection.
The exact dose amount is defined by the study protocol; the product label lists the dose as "0" with a non‑standard unit, indicating that the precise amount is controlled by the investigators.
Step 5
Ongoing monitoring and visits
You will attend regular clinic visits throughout the trial. During these visits, study staff will check for any signs of relapse (return of depressive symptoms) and will assess safety by recording any side effects or changes in health.
Each visit includes repeat questionnaires, physical examinations, and possibly laboratory tests, all aimed at tracking your progress from the day of randomization onward.
Step 6
Assessment of relapse
The primary goal of the study is to measure the time from randomization to the first occurrence of a relapse criterion for major depressive disorder. If you meet any relapse criterion, the study medication period ends for you, and you will receive appropriate clinical care.
The exact date of relapse is recorded as the primary outcome for the trial.
Step 7
Completion of study participation
If you do not experience a relapse, you will continue the assigned medication until the overall study end date (estimated to be 2028‑05‑28) or until the study protocol indicates a stop point.
At the final visit, you will undergo a comprehensive evaluation similar to the baseline assessment, and the study medication will be discontinued.

Who can join the trial?

6 criteria

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 trial?

5 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk, Poland
Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Responsive
Diamond Clinic Sp. z o.o.
Cracow, Poland

Trial locations

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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.

LY3537031

What is already known about the treatment

Brenipatide
This medication is given as a subcutaneous injection using a pre‑filled syringe containing a clear solution. It is currently an investigational drug being studied in Phase 3 clinical trials and is not yet approved for general medical use. Brenipatide is being tested as an additional treatment for adults with major depressive disorder to help keep symptoms from returning. It works by interacting with brain pathways that affect mood, and it is classified as an experimental peptide‑based antidepressant.
Placebo to match LY
The placebo is a harmless solution that looks the same as the active drug and is injected under the skin in the same type of pre‑filled syringe. It is used only in clinical studies to compare the effects of the real medication and has no therapeutic activity. The placebo helps researchers see whether Brenipatide truly improves depression symptoms beyond what might happen by chance. It is not a medication and has no pharmacological classification.

Investigated diseases

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.