Clinical trialNCT07412756RecruitingPhase 3Interventional

A Study of Brenipatide 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

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

Australia

Neurocentrix
Carlton, Australia
David Barton
Recruiting
Lyell Mcewin Hospital
Elizabeth Vale, Australia
Dennis Liu
Not, yet, recruiting
Barwon Health
Geelong, Australia
Roth Trisno
Recruiting
Multidisciplinary Alfred Psychiatry Research Centre
Melbourne, Australia
Rebecca Ho
Recruiting
Paratus Clinical Research - Melbourne
Melbourne, Australia
Paul Fitzgerald
Recruiting
Toowoomba Hospital
Toowoomba, Australia
Vikas Garg
Recruiting
Westmead Hospital
Westmead, Australia
Vlasios Brakoulias
Recruiting

Brazil

Hospital Das Clínicas Da Ufmg
Belo Horizonte, Brazil
Frederico Garcia
Not, yet, recruiting
Trial Tech
Curitiba, Brazil
Hamilton Grabowski
Recruiting
Clinilive
Maringá, Brazil
Antonio da Silva
Recruiting
Centro de Pesquisa Clínica de Marília - Cpclim
Marília, Brazil
Fernanda Guimarães
Recruiting
Hospital Universitário Onofre Lopes
Natal, Brazil
Walter Soares
Recruiting
Ruschel Medicina E Pesquisa Clínica
Rio de Janeiro, Brazil
Sandra Ruschel
Recruiting
Facili Centro Integrado de Psiquiatria
São Bernardo do Campo, Brazil
Cintia de Azevedo Marques Périco
Recruiting
Br Trials - Ensaios Clinicos E Consultoria
São Paulo, Brazil
Acioly Lacerda
Recruiting
Cpclin
São Paulo, Brazil
Denise Franco
Not, yet, recruiting
Cpquali Pesquisa Clínica
São Paulo, Brazil
Moacyr Rosa
Recruiting
A2z Clinical Centro Avançado de Pesquisa Clínica - Valinhos
Valinhos, Brazil
Caroline da Silva
Recruiting

Canada

Heritage Medical Research Clinic
Calgary, Canada
Thomas Raedler
Not, yet, recruiting
Premier Clinical Trial Network
Hamilton, Canada
Richard Tytus
Not, yet, recruiting
Kelowna Health and Memory Centre
Kelowna, Canada
Eugene Okorie
Not, yet, recruiting
Alpha Recherche Clinique - Lévis
Lévis, Canada
Julie Beaudoin
Recruiting
Genge Partners
Montreal, Canada
Simon Ducharme
Not, yet, recruiting
Dar Clinical Research - Ottawa
Ottawa, Canada
Jabir Jassam
Recruiting
Alpha Recherche Clinique
Québec, Canada
Jérôme Nadeau
Recruiting
Alpha Recherche Clinique
Québec, Canada
Raphael Poulin-Robitaille
Recruiting
Centre de Recherche Saint-Louis Inc.
Québec, Canada
Catherine Vaillancourt
Not, yet, recruiting
Richmond Clinical Trials
Richmond, Canada
Harris Lari
Recruiting
Bluewater Clinical Research Group Inc.
Sarnia, Canada
John O'Mahony
Not, yet, recruiting
Diex Recherche Sherbrooke
Sherbrooke, Canada
Suspended
Centre for Neurology Studies
Surrey, Canada
Shimi Kang
Not, yet, recruiting
Maple Leaf Research
Toronto, Canada
Suspended

China

Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing, China
Gang Wang
Recruiting
Beijing Huilongguan Hospital
Beijing, China
Yunlong Tan
Recruiting
the Second People'S Hospital of Hunan Province
Changsha, China
Xuhui Zhou
Recruiting
the Fourth People'S Hospital of Chengdu
Chengdu, China
Feiyan Wang
Recruiting
Guangzhou Brain Hospital
Guangzhou, China
Yuping Ning
Recruiting
Peking University Sixth Hospital
Haidian District, China
Hongyan Zhang
Recruiting
Hefei No.4 People'S Hospital
Hefei, China
Jianliang Gao
Recruiting
3rd People'S Hospital of Huzhou
Huzhou, China
Jianjun Liu
Recruiting

139 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: 9 Feb 2026
Primary completion: 29 Feb 2028
Completion: 29 Feb 2028
Last update posted: 6 Aug 2026
Registered enrollment: 1,000
Registry id: NCT07412756

Cross-registrations

EU-CTR / CTIS (EudraCT)2025-522308-25-00

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.