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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 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.
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
Completion Date
2029-02
Last Updated
2026-08-20
Healthy Volunteers
No
Conditions
Interventions
Brenipatide
Administered SC.
Placebo
Administered SC.
Locations (169)
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
De La Cruz Research Center, LLC
Miami, Florida, United States
CLA Research
Naples, Florida, United States
Charter Research - Orlando
Orlando, Florida, United States
Health Synergy Clinical Research
West Palm Beach, Florida, 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
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Suburban Research Associates
Media, Pennsylvania, United States
Adams Clinical Philadelphia
Philadelphia, Pennsylvania, United States
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, 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
Consano Clinical Research, LLC
Shavano Park, 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
Peninsula Therapeutic & Research Group
Frankston, 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
Anhui Medical University - Chaohu Hospital
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 GmbH
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
General Hospital of Tripoli Panarkadiko Evangelistria
Tripoli, Greece
Medical corporation Shinseikai Kaku Mental Clinic
Fukuoka, Japan
Kuramitsu Hospital
Fukuoka, Japan
Hinotoyoda Cocoro Clinic
Hino, Japan
Rainbow and Sea Hospital
Karatsu, Japan
Kishiro Mental Clinic
Kawasaki, Japan
Hiiragi Kokoro Clinic - Kokurain
Kitakyushu, 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
Maynds Tower Mental Clinic
Shibuya-ku, Japan
Etoh Mentalclinic Meguro
Shinagawa City, Japan
Tokumoto Komorebi Clinic
Suita, Japan
Sangenjaya Nakamura Mental Clinic
Tokyo, Japan
Miki Mental Clinic
Yokohama, Japan
Scientia Investigacion Clinica S.C.
Chihuahua City, Mexico
Scientia Investigacion Clinica Tj
Ciudad de Tijuana, Mexico
Investigación Clínica Cuernavaca, S.C.
Cuernavaca, Mexico
Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
Culiacán, Mexico
RM Pharma Specialists
Mexico City, Mexico
Ketamine Clinic México
Mexico City, Mexico
Human Science Research Trials
Mexico City, Mexico
Medical Care and Research SA de CV
Mérida, Mexico
FAICIC S. de R.L. de C.V.
Veracruz, Mexico
Núcleo de Investigación Médica Sur de Guadalajara
Zapopan, Mexico
Podlaskie Centrum Psychogeriatrii
Bialystok, Poland
MentalMEDIC
Bielsko-Biala, Poland
IN VIVO
Bydgoszcz, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Poland
Diamond Clinic
Krakow, Poland
NZOZ Psychiatrycznej Mentis
Leszno, Poland
Santa Familia PTG Lodz
Lodz, Poland
Nowy Szpital w Olkuszu
Olkusz, Poland
Private Practice - Dr. Małgorzata Wojtanowska-Bogacka
Poznan, Poland
Centrum Medyczne Ginemedica
Wroclaw, Poland
Clinhouse Centrum Medyczne
Zabrze, Poland
INSPIRA Clinical Research
San Juan, Puerto Rico
Instituto De Neurologia Dra. Ivonne Fraga
San Juan, Puerto Rico
Barbara Diaz-Hernandez MD Research, Inc.
San Juan, Puerto Rico
Korea University Ansan Hospital
Ansan-si, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Jeju National University Hospital
Jeju City, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Konkuk University Medical Center
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, South Korea
Parc de Salut Mar - Hospital del Mar
Barcelona, Spain
Institucion Hosp Hestia Palau
Barcelona, Spain
Parc Sanitari Sant Joan de Déu
Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
EAP Osona Sud - Alt Congost S.L.P
Centelles, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Centro de Salud Mental (CSM) La Corredoria
Oviedo, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, Spain
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
Seville, Spain
Hospital Universitario Virgen Del Rocio
Seville, Spain
Complejo Asistencial de Zamora
Zamora, Spain
Keelung Chang Gung Memorial Hospital
Keelung, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Cheng Hsin General Hospital
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan
Bodmin Community Hospital
Bodmin, United Kingdom
Edinburgh Royal Infirmary
Edinburgh, United Kingdom
Devon Partnership Trust
Exeter, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
NeuroClnx
Motherwell, United Kingdom
St Bartholomew's Medical Centre
Oxford, United Kingdom
Atlantic Medical
Penzance, United Kingdom
Ascend Clinical Research
Reading, United Kingdom
Woodstock Bower Surgery
Rotherham, United Kingdom