Brenipatide added to antidepressants for adults with major depressive disorder
Tests brenipatide as an add-on in adults whose depression symptoms persist on antidepressants.
Plain-language title generated from the registry record
Registry title: A Study of Brenipatide in Participants With Major Depressive Disorder
Key facts
- Where
- Bialystok, Bydgoszcz, Gdansk, Lodz, Lublin, Olkusz, Rybnik, Suchy Las, and Warsaw, PolandSee the 11 sites
- Phase
- Phase 2
AI summary: who the study is looking for
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 with major depression who still have symptoms while taking one stable antidepressant. Brenipatide or placebo is added to that medicine.
- Age
- 18 Years to 75 Years
- Sex
- All sexes can join.
- Disease stage
- Major Depressive Disorder in a current major depressive episode, without psychotic features. Partial response to the current antidepressant.
- Earlier treatment
- Must be on a stable antidepressant monotherapy regimen for the current episode. Must not have taken part in a clinical study with active treatment, or unknown active treatment, within 90 days or 5 half-lives (whichever is longer) before Visit 1.
Main reasons for not taking part
- Lifetime history or current schizophrenia, other psychotic disorder, bipolar disorder, borderline personality disorder, or any eating disorder
- Type 1 diabetes, or a history of ketoacidosis or hyperosmolar state or coma
- Substance or alcohol use disorder of any severity within 180 days before Visit 1
- Actively suicidal or a significant risk for suicide
- Neurocognitive disorders or intellectual disability
Read by machine on 11 November 2026.
Could this be for you?
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?
Source: NCT07928245, who can take part
Where in Poland
- MłynowaMed Specialist Psychiatric Medical Practice Joanna ŁazarczykBialystok, PolandNo longer taking part
- Wlokiennicza Praktyka Lekarska dr n. med. Tomasz MarkowskiBialystok, PolandNo longer taking part
- Promente - Center of Neurology and PsychogeriatricsBydgoszcz, PolandNo longer taking part
- Gdański Uniwersytet MedycznyGdansk, PolandNo longer taking part
- Penta Hospitals Badania Kliniczne - Gdańsk 1Gdansk, PolandNo longer taking part
- AmiCare Sp. z o.o. Sp. k.Lodz, PolandNo longer taking part
- Instytut Naukowo-Badawczy w Lublinie Sp. z o.o.Lublin, PolandNo longer taking part
- Nowy Szpital w OlkuszuOlkusz, PolandNo longer taking part
- M2M Med Badania Sp. Z o.oRybnik, PolandNo longer taking part
- Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger MolendaSuchy Las, PolandNo longer taking part
- IPIN Warsaw - Instytut Psychiatrii i Neurologii w Warszawie (IPIN)Warsaw, PolandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07928245EU 2026-527689-65-00
- Record updated
- 10 November 2026
- Original description
This study evaluates the safety and efficacy of brenipatide (LY3537031) as an add on therapy in participants with major depression who still have symptoms while taking a stable dose of standard of care anti-depressant medicine.Read full original descriptionShow less
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide Compared With Placebo in Adult Participants With Major Depressive Disorder Who Have Partial Response to Antidepressant Therapy (RENEW-MDD-3)
This study evaluates the safety and efficacy of brenipatide (LY3537031) as an add on therapy in participants with major depression who still have symptoms while taking a stable dose of standard of care anti-depressant medicine.
The study will last approximately 5 months.
Inclusion: Have a diagnosis of Major Depressive Disorder (MDD) and are in a current major depressive episode, without psychotic features; Are on a stable antidepressant monotherapy regimen for the current major depressive episode; Are a partial responder to the current antidepressant monotherapy regimen; 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: Have had a history of any substance or alcohol use disorder of any severity within 180 days before Visit 1; 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 Visit 1; Have a lifetime history or current diagnosis of the following:; schizophrenia or other psychotic disorder; bipolar disorder; borderline personality disorder; other personality disorders that would interfere with compliance with the study protocol; neurocognitive disorders or intellectual disability, or; any eating disorder; Have type 1 diabetes mellitus, or a history of; ketoacidosis, or; hyperosmolar state or coma; Are actively suicidal or deemed a significant risk for suicide.