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A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
Sponsor: Eli Lilly and Company
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2026-08-14
Completion Date
2029-02
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Brenipatide
Administered SC.
Placebo
Administered SC.
Locations (170)
University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama, United States
NoesisPharma, LLC
Phoenix, Arizona, United States
Irvine Clinical Research
Irvine, California, United States
Healthy Brain Clinic
Long Beach, California, United States
Oakland Clinical
Oakland, California, United States
Concierge Clinical Trials
Valley Village, California, United States
JEM Research Institute
Atlantis, Florida, United States
Bradenton Research Center, Inc.
Bradenton, Florida, United States
Key Clinical Research
Bradenton, Florida, United States
NextPhase Research Florida - Hollywood
Hollywood, Florida, United States
Miami Jewish health
Miami, Florida, United States
Quantix Research - Miami - Southwest 72nd Street
Miami, Florida, United States
Diverse Clinical Research
Miami, Florida, United States
CLA Research
Naples, Florida, United States
Health Synergy Clinical Research
West Palm Beach, Florida, United States
CenExel iResearch, LLC
Decatur, Georgia, United States
AGILE Clinical Research Trials, LLC
Sandy Springs, Georgia, United States
Charter Research - Chicago
Chicago, Illinois, United States
Pharmasite Research, Inc.
Baltimore, Maryland, United States
Adams Clinical Boston
Boston, Massachusetts, United States
Adams Clinical Watertown
Watertown, Massachusetts, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
Be Well Clinical Studies - Omaha
Omaha, Nebraska, United States
Adams Clinical Bronx
The Bronx, New York, United States
Adams Clinical Philadelphia
Philadelphia, Pennsylvania, United States
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Suburban Research Associates
West Chester, Pennsylvania, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Gadolin Research
Beaumont, Texas, United States
Adams Clinical Dallas
DeSoto, Texas, United States
The University of Texas Rio Grande Valley
Harlingen, Texas, United States
Olympus Clinical Research
Katy, Texas, United States
Boeson Research - Provo
Provo, Utah, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Ramsay Clinic New Farm
Brisbane, Australia
Paratus Clinical Research Canberra
Bruce, Australia
NeuroCentrix
Carlton, Australia
Lyell McEwin Hospital
Elizabeth Vale, Australia
Barwon Health
Geelong, Australia
Multidisciplinary Alfred Psychiatry Research Centre
Melbourne, Australia
Ramsay Clinic Albert Road
Melbourne, Australia
Toowoomba Hospital
Toowoomba, Australia
Westmead Hospital
Westmead, Australia
Instituto de Pesquisa clinica de Campinas
Campinas, Brazil
Cline Research Center
Curitiba, Brazil
Clínica Neurológica
Joinville, Brazil
Instituto Méderi de Pesquisa e Saúde
Passo Fundo, Brazil
Hospital das Clínicas - UFPE
Recife, Brazil
Centro Multidisciplinar de Estudos Clinicos
São Bernardo do Campo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, Brazil
PSEG Centro de Pesquisa Clínica
São Paulo, Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, Brazil
CEDOES
Vitória, Brazil
Integral Pesquisa e Ensino
Votuporanga, Brazil
CaRe Clinic
Calgary, Canada
Kelowna Health and Memory Centre
Kelowna, Canada
Providence Care
Kingston, Canada
Alpha Recherche Clinique - Lévis
Lévis, Canada
AMNDX
Markham, Canada
Malton Medical Group
Mississauga, Canada
Alpha Recherche Clinique
Québec, Canada
ALPHA Recherche Clinique
Québec, Canada
Richmond Clinical Trials
Richmond, Canada
Research, Innovation, Science and Excellence (RISE) Institute
Toronto, Canada
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing, China
Chaohu Hospital of Anhui Medical University
Chaohu, China
Shandong Mental Health Center
Jinan, China
Linfen Central Hospital
Linfen, China
Shanghai Tongji Hospital
Shanghai, China
Suzhou Guangji Hospital
Suzhou, China
Tianjin Anding Hospital
Tianjin, China
The Affiliated Kangning Hospital of Wenzhou Medical University
Wenzhou, China
Wuhu Hospital of Beijing Anding hospital
Wuhu, China
Zhenjiang Mental Health Center
Zhenjiang, China
FutureMeds Berlin
Berlin, Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin
Berlin, Germany
Pharmakologisches Studienzentrum Chemnitz
Chemnitz, Germany
Klinische Forschung Hamburg
Hamburg, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Somni bene
Schwerin, Germany
Argolida General Hospital
Argos, Greece
Multidisciplinary Mental Health Hospital of Attiki
Athens, Greece
Sismanogleio General Hospital of Attiki
Athens, Greece
Attikon General University Hospital
Chaïdári, Greece
University Hospital of Ioannina
Ioannina, Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, Greece
Medical corporation Shinseikai Kaku Mental Clinic
Fukuoka, Japan
Kuramitsu Hospital
Fukuoka, Japan
UNB Sumiyoshi Jinjamae Clinic
Hakata-Ku, Japan
Hinotoyoda Cocoro Clinic
Hino, Japan
Rainbow and Sea Hospital
Karatsu, Japan
Kishiro Mental Clinic
Kawasaki, Japan
Hiiragi Kokoro Clinic - Kokurain
Kitakyushu, Japan
Juntendo Koshigaya Hospital
Koshigaya, Japan
Monzen-nakacho Mental Clinic
Kōtō City, Japan
National Hospital Organization Shimofusa Psychiatric Medical Center
MIdori-ku, Chiba-shi, Japan
Tokyo Nakano Mental Clinic
Nakano City, Japan
Watanabe Clinic
Osaka, Japan
Yutaka Clinic
Sagamihara, Japan
Kitasato University Hospital
Sagamihara, Japan