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
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 aged 18 to 75 with major depression who already take a stable standard medicine for it. It tests brenipatide against placebo for delaying a return of depression.
- Age
- 18 to 75 years
- Sex
- All sexes
- Disease stage
- Major depressive disorder, on stable standard of care medication
- Earlier treatment
- Must be on stable standard of care medication for major depressive disorder. Must not have had active treatment in another clinical study within 90 days or 5 half-lives (whichever is longer) before screening.
Main reasons for not taking part
- Schizophrenia spectrum or other psychotic disorder, bipolar disorder, borderline personality disorder or any eating disorder (lifetime or current)
- 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 a significant suicide risk
- Active treatment in another clinical study within 90 days or 5 half-lives before screening
Read by machine on 12 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: NCT07775300, who can take part
Where in Japan
- Kuramitsu HospitalFukuoka, JapanContact: Noriko Tamaru (principal investigator)Not yet recruiting
- Medical corporation Shinseikai Kaku Mental ClinicFukuoka, JapanContact: Hiromitsu Kaku (principal investigator)Not yet recruiting
- UNB Sumiyoshi Jinjamae ClinicHakata-Ku, JapanContact: Naoya Oribe (principal investigator)Not yet recruiting
- Hinotoyoda Cocoro ClinicHino, JapanContact: Yuichiro Tsutsumi (principal investigator)Not yet recruiting
- Rainbow and Sea HospitalKaratsu, JapanContact: Taro Shindo (principal investigator)Not yet recruiting
- Kishiro Mental ClinicKawasaki, JapanContact: Masaki Kishiro (principal investigator)Not yet recruiting
- Hiiragi Kokoro Clinic - KokurainKitakyushu, JapanContact: TASUKU NISHIYAMA (principal investigator)Not yet recruiting
- Juntendo Koshigaya HospitalKoshigaya, JapanContact: baba hajime (principal investigator)Not yet recruiting
- Monzen-nakacho Mental ClinicKōtō City, JapanContact: Junpei Sekiya (principal investigator)Not yet recruiting
- National Hospital Organization Shimofusa Psychiatric Medical CenterMIdori-ku, Chiba-shi, JapanContact: Teruki Koizumi (principal investigator)Not yet recruiting
- Tokyo Nakano Mental ClinicNakano City, JapanContact: Hironobu Ohtsuchi (principal investigator)Not yet recruiting
- Watanabe ClinicOsaka, JapanContact: Kenichi Watanabe (principal investigator)Not yet recruiting
- Kitasato University HospitalSagamihara, JapanContact: Hiroyuki Muraoka (principal investigator)Not yet recruiting
- Yutaka ClinicSagamihara, JapanContact: Hideo Muraoka (principal investigator)Not yet recruiting
- Maynds Tower Mental ClinicShibuya-ku, JapanContact: Nobutoshi Kariya (principal investigator)Not yet recruiting
- Etoh Mentalclinic MeguroShinagawa City, JapanContact: Akemi Eto (principal investigator)Not yet recruiting
- Tokumoto Komorebi ClinicSuita, JapanContact: TAKAHIRO TOKUMOTO (principal investigator)Not yet recruiting
- Sangenjaya Nakamura Mental ClinicTokyo, JapanContact: Satoshi Nakamura (principal investigator)Not yet recruiting
- Ikebukuro Olive Mental ClinicToshima City, JapanContact: Sachie Matsushima (principal investigator)Not yet recruiting
- Miki Mental ClinicYokohama, JapanContact: Kazuhira Miki (principal investigator)Not yet recruiting
- Yokohama Mental Clinic TotsukaYokohama, JapanContact: Takashi Hayama (principal investigator)Not 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.