Brenipatide added to usual care to delay return of major depression
Tests brenipatide alongside usual care in adults with major depressive disorder.
Plain-language title generated from the registry record
Registry title: A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
Key facts
- Where
- Fukuoka, Hakata-Ku, Hino, Karatsu, Kawasaki, Kitakyushu, Koshigaya, Kōtō City, MIdori-ku, Chiba-shi, Nakano City, Osaka, Sagamihara, Shibuya-ku, Shinagawa City, Suita, Tokyo, Toshima City, and Yokohama, JapanSee the 21 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?
Source: NCT07775300, who can take part
Where in Japan
- Kuramitsu HospitalFukuoka, JapanNot yet recruiting
- Medical corporation Shinseikai Kaku Mental ClinicFukuoka, JapanNot yet recruiting
- UNB Sumiyoshi Jinjamae ClinicHakata-Ku, JapanNot yet recruiting
- Hinotoyoda Cocoro ClinicHino, JapanNot yet recruiting
- Rainbow and Sea HospitalKaratsu, JapanNot yet recruiting
- Kishiro Mental ClinicKawasaki, JapanNot yet recruiting
- Hiiragi Kokoro Clinic - KokurainKitakyushu, JapanNot yet recruiting
- Juntendo Koshigaya HospitalKoshigaya, JapanNot yet recruiting
- Monzen-nakacho Mental ClinicKōtō City, JapanNot yet recruiting
- National Hospital Organization Shimofusa Psychiatric Medical CenterMIdori-ku, Chiba-shi, JapanNot yet recruiting
- Tokyo Nakano Mental ClinicNakano City, JapanNot yet recruiting
- Watanabe ClinicOsaka, JapanNot yet recruiting
- Kitasato University HospitalSagamihara, JapanNot yet recruiting
- Yutaka ClinicSagamihara, JapanNot yet recruiting
- Maynds Tower Mental ClinicShibuya-ku, JapanNot yet recruiting
- Etoh Mentalclinic MeguroShinagawa City, JapanNot yet recruiting
- Tokumoto Komorebi ClinicSuita, JapanNot yet recruiting
- Sangenjaya Nakamura Mental ClinicTokyo, JapanNot yet recruiting
- Ikebukuro Olive Mental ClinicToshima City, JapanNot yet recruiting
- Miki Mental ClinicYokohama, JapanNot yet recruiting
- Yokohama Mental Clinic TotsukaYokohama, JapanNot yet recruiting
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
- NCT07775300EU 2025-522310-24-00
- Record updated
- 3 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- 2)
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 and a post- treatment period that combined will last a minimum of 12 months, and the safety follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.
Inclusion: Meet the diagnostic criteria for major depressive disorder; Are on 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 spectrum 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.