Brenipatide added to usual care for adults with major depressive disorder
Tests brenipatide, added to usual care, in adults with major depressive disorder.
Plain-language title generated from the registry record
Registry title: A Study of Brenipatide in Adult Participants With Major Depressive Disorder
Key facts
- Where
- Bialystok, Bielsko-Biala, Gdansk, Krakow, Poznan, Szczecin, Wroclaw, and Zabrze, PolandSee the 8 sites
- Phase
- Phase 3
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 depressive disorder who take a stable standard medication for it. It tests brenipatide against placebo to delay the return of depressive symptoms.
- Age
- 18 to 75 years
- Sex
- Men and women
- Disease stage
- Major depressive disorder
- Earlier treatment
- Must be on a stable standard of care medication for major depressive disorder.
Main reasons for not taking part
- Schizophrenia or 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
- Moderate or severe substance or alcohol use disorder within 180 days of screening
- Actively suicidal or at significant risk for suicide
- Active treatment in another clinical study within 90 days or 5 half-lives (whichever is longer) before screening
Read by machine on 9 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: NCT07412756, who can take part
Where in Poland
- Podlaskie Centrum PsychogeriatriiBialystok, PolandTaking people
- MentalMEDICBielsko-Biala, PolandNot yet recruiting
- Centrum Badan Klinicznych PI-House sp. z o.o.Gdansk, PolandNot yet recruiting
- Diamond ClinicKrakow, PolandTaking people
- Private Practice - Dr. Małgorzata Wojtanowska-BogackaPoznan, PolandTaking people
- Centrum Medyczne EuromedisSzczecin, PolandNot yet recruiting
- Centrum Medyczne GinemedicaWroclaw, PolandTaking people
- ClinHouse Centrum MedyczneZabrze, PolandTaking people
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
- NCT07412756EU 2025-522308-25-00
- Record updated
- 4 November 2026
- Original description
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
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 1)
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.
The trial is divided into four periods as follows: a screening period that will last approximately 1 month, a treatment period with a potential post treatment period that combined will last a minimum of 12 months, and the follow up period that will last approximately 2 months.
Inclusion: Meet the diagnostic criteria for major depressive disorder; Are on a 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.
Exclusion: 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 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.