Clinical trialNCT07775300Not, yet, recruitingPhase 3Interventional

A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder

SponsorEli Lilly and CompanyEnrollment1,000Depressive Disorder, Major

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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 three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and the 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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

169 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia

Ramsay Clinic New Farm
Brisbane, Australia
James Scott
Paratus Clinical Research Canberra
Bruce, Australia
Paul Fitzgerald
Neurocentrix
Carlton, Australia
David Barton
Lyell Mcewin Hospital
Elizabeth Vale, Australia
Dennis Liu
Peninsula Therapeutic & Research Group
Frankston, Australia
Jennifer Grunfeld
Barwon Health
Geelong, Australia
Roth Trisno
Multidisciplinary Alfred Psychiatry Research Centre
Melbourne, Australia
Rebecca Ho
Ramsay Clinic Albert Road
Melbourne, Australia
Malcolm Hopwood
Toowoomba Hospital
Toowoomba, Australia
Vikas Garg
Westmead Hospital
Westmead, Australia
Vlasios Brakoulias

Brazil

Instituto de Pesquisa Clinica de Campinas
Campinas, Brazil
Alexandre Comandule
Cline Research Center
Curitiba, Brazil
Silmara Leite
Clínica Neurológica
Joinville, Brazil
Alexandre Longo
Instituto Méderi de Pesquisa E Saúde
Passo Fundo, Brazil
Jacson Hubner
Hospital Das Clínicas - Ufpe
Recife, Brazil
Hugo Melo
Centro Multidisciplinar de Estudos Clinicos
São Bernardo do Campo, Brazil
Flavia Pinto
Fundação Faculdade Regional de Medicina de São José Do Rio Preto
São José do Rio Preto, Brazil
Gerardo Araujo-Filho
Cepic - Centro Paulista de Investigação Clínica
São Paulo, Brazil
Lauro Goncalves
Pseg Centro de Pesquisa Clínica
São Paulo, Brazil
Paulo Victor Sgobbi de Souza
Cedoes
Vitória, Brazil
Rafael Riva
Integral Pesquisa E Ensino
Votuporanga, Brazil
Kamila Carvalho

Canada

Care Clinic
Calgary, Canada
Payman Hajiazim
Kelowna Health and Memory Centre
Kelowna, Canada
Eugene Okorie
Providence Care
Kingston, Canada
Roumen Milev
Alpha Recherche Clinique - Lévis
Lévis, Canada
Steeve Kwan Tat
Amndx
Markham, Canada
Alan Lowe
Malton Medical Group
Mississauga, Canada
Brian Zidel
Alpha Recherche Clinique
Québec, Canada
Xavier Mignault
Alpha Recherche Clinique
Québec, Canada
Raphael Poulin-Robitaille
Richmond Clinical Trials
Richmond, Canada
Harris Lari
Research, Innovation, Science and Excellence (rise) Institute
Toronto, Canada
Roger McIntyre

China

Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing, China
Gang Wang
Anhui Medical University - Chaohu Hospital
Chaohu, China
Kai Zhang
Shandong Mental Health Center
Jinan, China
Xu Chen
Linfen Central Hospital
Linfen, China
Yan Dong
Shanghai Tongji Hospital
Shanghai, China
Yuan Shen
Suzhou Guangji Hospital
Suzhou, China
Chuanwei Li
Tianjin Anding Hospital
Tianjin, China
Lina Wang
the Affiliated Kangning Hospital of Wenzhou Medical University
Wenzhou, China
Wei Tang
Wuhu Hospital of Beijing Anding Hospital
Wuhu, China
Changqing Hu

129 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

BrenipatidePlacebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Aug 2026
Primary completion: 31 Dec 2028
Completion: 28 Feb 2029
Last update posted: 20 Aug 2026
Registered enrollment: 1,000
Registry id: NCT07775300

Cross-registrations

EU-CTR / CTIS (EudraCT)2025-522310-24-00

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.