A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
Start Date
8/14/2026
Completion Date
2/1/2029
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.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
Brenipatide
Placebo
Conditions
Locations
University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama 35294
United States
NoesisPharma, LLC
Phoenix, Arizona 85028
United States
Irvine Clinical Research
Irvine, California 92614
United States
Healthy Brain Clinic
Long Beach, California 90804
United States
Oakland Clinical
Oakland, California 94609
United States
Concierge Clinical Trials
Valley Village, California 91607
United States
JEM Research Institute
Atlantis, Florida 33462
United States
Bradenton Research Center, Inc.
Bradenton, Florida 34205
United States
Key Clinical Research
Bradenton, Florida 34207
United States
NextPhase Research Florida - Hollywood
Hollywood, Florida 33024
United States
Miami Jewish health
Miami, Florida 33137
United States
Quantix Research - Miami - Southwest 72nd Street
Miami, Florida 33173
United States
Diverse Clinical Research
Miami, Florida 33175
United States
CLA Research
Naples, Florida 34116
United States
Health Synergy Clinical Research
West Palm Beach, Florida 33407
United States
CenExel iResearch, LLC
Decatur, Georgia 30030
United States
AGILE Clinical Research Trials, LLC
Sandy Springs, Georgia 30328
United States
Charter Research - Chicago
Chicago, Illinois 60618
United States
Pharmasite Research, Inc.
Baltimore, Maryland 21208
United States
Adams Clinical Boston
Boston, Massachusetts 02116
United States
Adams Clinical Watertown
Watertown, Massachusetts 02472
United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan 48098
United States
Be Well Clinical Studies - Omaha
Omaha, Nebraska 68144
United States
Adams Clinical Bronx
The Bronx, New York 10461
United States
Adams Clinical Philadelphia
Philadelphia, Pennsylvania 19104
United States
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania 19104
United States
Suburban Research Associates
West Chester, Pennsylvania 19380
United States
FutureSearch Trials of Neurology
Austin, Texas 78731
United States
Gadolin Research
Beaumont, Texas 77702
United States
Adams Clinical Dallas
DeSoto, Texas 75115
United States
The University of Texas Rio Grande Valley
Harlingen, Texas 78550
United States
Olympus Clinical Research
Katy, Texas 77450
United States
Boeson Research - Provo
Provo, Utah 84604
United States
Northwest Clinical Research Center
Bellevue, Washington 98007
United States
Ramsay Clinic New Farm
Brisbane, 4005
Australia
Paratus Clinical Research Canberra
Bruce, 2617
Australia
NeuroCentrix
Carlton, 3053
Australia
Lyell McEwin Hospital
Elizabeth Vale, 5112
Australia
Barwon Health
Geelong, 3220
Australia
Multidisciplinary Alfred Psychiatry Research Centre
Melbourne, 3004
Australia
Ramsay Clinic Albert Road
Melbourne, 3004
Australia
Toowoomba Hospital
Toowoomba, 4350
Australia
Westmead Hospital
Westmead, 2145
Australia
Instituto de Pesquisa clinica de Campinas
Campinas, 13060-080
Brazil
Cline Research Center
Curitiba, 80030-480
Brazil
Clínica Neurológica
Joinville, 89202190
Brazil
Instituto Méderi de Pesquisa e Saúde
Passo Fundo, 99010-120
Brazil
Hospital das Clínicas - UFPE
Recife, 50670-420
Brazil
Centro Multidisciplinar de Estudos Clinicos
São Bernardo do Campo, 09715-090
Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, 15090000
Brazil
PSEG Centro de Pesquisa Clínica
São Paulo, 04038-002
Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010
Brazil
CEDOES
Vitória, 29055450
Brazil
Integral Pesquisa e Ensino
Votuporanga, 15500-269
Brazil
CaRe Clinic
Calgary, T2N 4L7
Canada
Kelowna Health and Memory Centre
Kelowna, V1Y 5A8
Canada
Providence Care
Kingston, K7L 4X3
Canada
Alpha Recherche Clinique - Lévis
Lévis, G6V 0C9
Canada
AMNDX
Markham, L3R 1A3
Canada
Malton Medical Group
Mississauga, L4T 4J2
Canada
Alpha Recherche Clinique
Québec, G2J 0C4
Canada
ALPHA Recherche Clinique
Québec, G3K 2P8
Canada
Richmond Clinical Trials
Richmond, V6V 2L1
Canada
Research, Innovation, Science and Excellence (RISE) Institute
Toronto, L5L 1W8
Canada
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing, 100088
China
Chaohu Hospital of Anhui Medical University
Chaohu, 238001
China
Shandong Mental Health Center
Jinan, 250012
China
Linfen Central Hospital
Linfen, 041000
China
Shanghai Tongji Hospital
Shanghai, 200065
China
Suzhou Guangji Hospital
Suzhou, 215003
China
Tianjin Anding Hospital
Tianjin, 300022
China
The Affiliated Kangning Hospital of Wenzhou Medical University
Wenzhou, 325007
China
Wuhu Hospital of Beijing Anding hospital
Wuhu, 242407
China
Zhenjiang Mental Health Center
Zhenjiang, 212000
China
FutureMeds Berlin
Berlin, 10629
Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin
Berlin, 12203
Germany
Pharmakologisches Studienzentrum Chemnitz
Chemnitz, 09111
Germany
Klinische Forschung Hamburg
Hamburg, 20253
Germany
Universitätsklinikum Leipzig
Leipzig, 04103
Germany
Somni bene
Schwerin, 19053
Germany
Argolida General Hospital
Argos, 212 00
Greece
Multidisciplinary Mental Health Hospital of Attiki
Athens, 124 62
Greece
Sismanogleio General Hospital of Attiki
Athens, 151 26
Greece
Attikon General University Hospital
Chaïdári, 124 62
Greece
University Hospital of Ioannina
Ioannina, 455 00
Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, 564 29
Greece
Medical corporation Shinseikai Kaku Mental Clinic
Fukuoka, 810-0022
Japan
Kuramitsu Hospital
Fukuoka, 819-0037
Japan
UNB Sumiyoshi Jinjamae Clinic
Hakata-Ku, 812-0018
Japan
Hinotoyoda Cocoro Clinic
Hino, 191-0062
Japan
Rainbow and Sea Hospital
Karatsu, 847-0031
Japan
Kishiro Mental Clinic
Kawasaki, 214-0014
Japan
Hiiragi Kokoro Clinic - Kokurain
Kitakyushu, 802-0001
Japan
Juntendo Koshigaya Hospital
Koshigaya, 343-0032
Japan
Monzen-nakacho Mental Clinic
Kōtō City, 135-0047
Japan
National Hospital Organization Shimofusa Psychiatric Medical Center
MIdori-ku, Chiba-shi, 266-0007
Japan
Tokyo Nakano Mental Clinic
Nakano City, 164-0001
Japan
Watanabe Clinic
Osaka, 541-0043
Japan
Yutaka Clinic
Sagamihara, 252-0303
Japan
Kitasato University Hospital
Sagamihara, 252-0375
Japan
Maynds Tower Mental Clinic
Shibuya-ku, 151-0053
Japan
Etoh Mentalclinic Meguro
Shinagawa City, 141-0021
Japan
Tokumoto Komorebi Clinic
Suita, 564-0063
Japan
Sangenjaya Nakamura Mental Clinic
Tokyo, 154-0004
Japan
Ikebukuro Olive Mental Clinic
Toshima City, 170-0013
Japan
Miki Mental Clinic
Yokohama, 220-0023
Japan
Yokohama Mental Clinic Totsuka
Yokohama, 244-0816
Japan
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207
Mexico
Scientia Investigacion Clinica Tj
Ciudad de Tijuana, 22105
Mexico
Investigación Clínica Cuernavaca, S.C.
Cuernavaca, 62448
Mexico
Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
Culiacán, 80230
Mexico
RM Pharma Specialists
Mexico City, 03100
Mexico
Ketamine Clinic México
Mexico City, 04100
Mexico
Human Science Research Trials
Mexico City, 14050
Mexico
Medical Care and Research SA de CV
Mérida, 97070
Mexico
FAICIC S. de R.L. de C.V.
Veracruz, 91900
Mexico
Núcleo de Investigación Médica Sur de Guadalajara
Zapopan, 45070
Mexico
Podlaskie Centrum Psychogeriatrii
Bialystok, 15-756
Poland
MentalMEDIC
Bielsko-Biala, 43-300
Poland
IN VIVO
Bydgoszcz, 85-048
Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, 80-546
Poland
Diamond Clinic
Krakow, 31-559
Poland
NZOZ Psychiatrycznej Mentis
Leszno, 64-100
Poland
Santa Familia PTG Lodz
Lodz, 90-302
Poland
Nowy Szpital w Olkuszu
Olkusz, 32-300
Poland
Private Practice - Dr. Małgorzata Wojtanowska-Bogacka
Poznan, 60-192
Poland
Centrum Medyczne Ginemedica
Wroclaw, 50-414
Poland
Clinhouse Centrum Medyczne
Zabrze, 41-807
Poland
INSPIRA Clinical Research
San Juan, 00918
Puerto Rico
Instituto De Neurologia Dra. Ivonne Fraga
San Juan, 00918
Puerto Rico
Barbara Diaz-Hernandez MD Research, Inc.
San Juan, 00926
Puerto Rico
Korea University Ansan Hospital
Ansan-si, 15355
South Korea
Chonnam National University Hospital
Gwangju, 61469
South Korea
Jeju National University Hospital
Jeju City, 63241
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Konkuk University Medical Center
Seoul, 05030
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591
South Korea
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003
Spain
Institucion Hosp Hestia Palau
Barcelona, 08025
Spain
Parc Sanitari Sant Joan de Déu
Barcelona, 08029
Spain
Hospital Clínic de Barcelona
Barcelona, 08036
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Spain
EAP Osona Sud - Alt Congost S.L.P
Centelles, 08540
Spain
Hospital Universitario Infanta Leonor
Madrid, 28031
Spain
Centro de Salud Mental (CSM) La Corredoria
Oviedo, 33011
Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37005
Spain
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
Seville, 41003
Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013
Spain
Complejo Asistencial de Zamora
Zamora, 49021
Spain
Keelung Chang Gung Memorial Hospital
Keelung, 204
Taiwan
Chung Shan Medical University Hospital
Taichung, 402
Taiwan
Taichung Veterans General Hospital
Taichung, 407
Taiwan
National Cheng Kung University Hospital
Tainan, 704
Taiwan
National Taiwan University Hospital
Taipei, 10002
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Cheng Hsin General Hospital
Taipei, 112
Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Taiwan
Bodmin Community Hospital
Bodmin, PL31 2QT
United Kingdom
Edinburgh Royal Infirmary
Edinburgh, EH16 4SA
United Kingdom
Devon Partnership Trust
Exeter, EX2 5AF
United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF
United Kingdom
Avrin - Liverpool
Liverpool, L24 7RB
United Kingdom
NeuroClnx
Motherwell, ML1 4UF
United Kingdom
St Bartholomew's Medical Centre
Oxford, OX4 1XB
United Kingdom
Atlantic Medical
Penzance, TR18 3DX
United Kingdom
Ascend Clinical Research
Reading, RG7 8PA
United Kingdom
Woodstock Bower Surgery
Rotherham, S61 1AH
United Kingdom