A Study of Brenipatide in Adult Participants With Major Depressive Disorder
Key facts
- Where
- Calgary, Hamilton, Kelowna, Lévis, Montreal, Ottawa, Québec, Richmond, Sarnia, Sherbrooke, Surrey, and Toronto, CanadaSee the 13 sites
- Phase
- Phase 3
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?
Where in Canada
- Heritage Medical Research ClinicCalgary, CanadaNot yet recruiting
- Hamilton Medical Research GroupHamilton, CanadaTaking people
- Kelowna Health and Memory CentreKelowna, CanadaTaking people
- Alpha Recherche Clinique - LévisLévis, CanadaTaking people
- Genge PartnersMontreal, CanadaTaking people
- Dar Clinical Research - OttawaOttawa, CanadaTaking people
- Alpha Recherche CliniqueQuébec, CanadaTaking people
- Centre de Recherche Saint-Louis inc.Québec, CanadaNot yet recruiting
- Richmond Clinical TrialsRichmond, CanadaTaking people
- Bluewater Clinical Research Group Inc.Sarnia, CanadaTaking people
- Diex Recherche SherbrookeSherbrooke, CanadaNo longer taking part
- Centre for Neurology StudiesSurrey, CanadaTaking people
- Maple Leaf ResearchToronto, CanadaNo 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
- 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.