A Study of Brenipatide in Adult Participants With Major Depressive Disorder (RENEW-MDD-1)

June 9, 2026 updated by: Eli Lilly and Company

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 1)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Australia
      • Brisbane, Australia, 4101
        • Not yet recruiting
        • Mater Misericordiae Limited
        • Principal Investigator:
          • Tatjana Ewais
      • Carlton, Australia, 3053
        • Not yet recruiting
        • NeuroCentrix
        • Principal Investigator:
          • David Barton
        • Contact:
          • Phone Number: 61395460009
      • Elizabeth Vale, Australia, 5112
        • Not yet recruiting
        • Lyell McEwin Hospital
        • Contact:
          • Phone Number: 0881829554
        • Principal Investigator:
          • Dennis Liu
      • Geelong, Australia, 3220
        • Not yet recruiting
        • Barwon Health
        • Principal Investigator:
          • Roth Trisno
      • Melbourne, Australia, 3070
        • Not yet recruiting
        • Paratus Clinical Research - Melbourne
        • Principal Investigator:
          • Paul Fitzgerald
      • Melbourne, Australia, 3004
        • Not yet recruiting
        • Multidisciplinary Alfred Psychiatry Research Centre
        • Principal Investigator:
          • Rebecca Ho
      • Mildura, Australia, 3500
        • Not yet recruiting
        • Mildura Base Hospital
        • Principal Investigator:
          • Robert Lundin
      • Toowoomba, Australia, 4350
        • Not yet recruiting
        • Toowoomba Hospital
        • Principal Investigator:
          • Vikas Garg
      • Waitara, Australia, 2077
        • Not yet recruiting
        • Innovate Clinical Research
        • Principal Investigator:
          • Anthony McGirr
        • Contact:
          • Phone Number: +61 2 91593838
      • Westmead, Australia, 2145
        • Not yet recruiting
        • Westmead Hospital
        • Principal Investigator:
          • Vlasios Brakoulias
  • Brazil
      • Belo Horizonte, Brazil, 30130-100
        • Not yet recruiting
        • Hospital das Clínicas da UFMG
        • Contact:
          • Phone Number: 31991990093
        • Principal Investigator:
          • Frederico Garcia
      • Curitiba, Brazil, 80240-280
        • Not yet recruiting
        • Trial Tech
        • Contact:
          • Phone Number: 41992061583
        • Principal Investigator:
          • Hamilton Grabowski
      • Maringá, Brazil, 87013-250
        • Not yet recruiting
        • Clinilive
        • Principal Investigator:
          • Antonio da Silva
      • Marília, Brazil, 17504-072
        • Not yet recruiting
        • Centro de Pesquisa Clínica de Marília - CPCLIM
        • Contact:
          • Phone Number: 5511944404464
        • Principal Investigator:
          • Fernanda Guimarães
      • Natal, Brazil, 59012-300
        • Not yet recruiting
        • Hospital Universitário Onofre Lopes
        • Principal Investigator:
          • Walter Soares
      • Rio de Janeiro, Brazil, 22270-060
        • Not yet recruiting
        • Ruschel Medicina e Pesquisa Clínica
        • Contact:
          • Phone Number: 55 21 35979708
        • Principal Investigator:
          • Sandra Ruschel
      • São Bernardo do Campo, Brazil, 09726-150
        • Not yet recruiting
        • Facili Centro Integrado de Psiquiatria
        • Contact:
          • Phone Number: +55 11 99399-0508
        • Principal Investigator:
          • Cintia de Azevedo Marques Périco
      • São Paulo, Brazil, 01228-000
        • Not yet recruiting
        • CPQuali Pesquisa Clínica
        • Contact:
          • Phone Number: +55 (11) 2776-6801
        • Principal Investigator:
          • Moacyr Rosa
      • São Paulo, Brazil, 01228-200
        • Not yet recruiting
        • CPCLIN
        • Principal Investigator:
          • Denise Franco
        • Contact:
          • Phone Number: 551126303777
      • São Paulo, Brazil, 01236030
        • Not yet recruiting
        • BR Trials - Ensaios Clinicos e Consultoria
        • Contact:
          • Phone Number: 1126722734
        • Principal Investigator:
          • Acioly Lacerda
      • Valinhos, Brazil, 13271-130
        • Not yet recruiting
        • A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos
        • Principal Investigator:
          • Caroline da Silva
  • Canada
      • Calgary, Canada, T2N 4Z6
        • Not yet recruiting
        • Heritage Medical Research Clinic
        • Contact:
          • Phone Number: +14032202130
        • Principal Investigator:
          • Thomas Raedler
      • Hamilton, Canada, L8L 5G4
        • Not yet recruiting
        • Premier Clinical Trial Network
        • Principal Investigator:
          • Richard Tytus
        • Contact:
          • Phone Number: +1 289 201 5233
      • Hamilton, Canada, L8J 0B6
        • Not yet recruiting
        • Winterberry Research Inc.
        • Principal Investigator:
          • Steven Zizzo
        • Contact:
          • Phone Number: 365-366-6267
      • Lévis, Canada, G6V 0C9
        • Not yet recruiting
        • Alpha Recherche Clinique - Lévis
        • Principal Investigator:
          • Julie Beaudoin
      • Montreal, Canada, H4A 3T2
        • Not yet recruiting
        • Genge Partners
        • Principal Investigator:
          • Simon Ducharme
      • Ottawa, Canada, K2J 3Z6
        • Not yet recruiting
        • Dar Clinical Research - Ottawa
        • Principal Investigator:
          • Jabir Jassam
      • Québec, Canada, G3K 2P8
        • Not yet recruiting
        • ALPHA Recherche Clinique
        • Principal Investigator:
          • Jérôme Nadeau
        • Contact:
          • Phone Number: 418-847-1112
      • Québec, Canada, G2J 0C4
        • Not yet recruiting
        • ALPHA Recherche Clinique
        • Principal Investigator:
          • Raphael Poulin-Robitaille
        • Contact:
          • Phone Number: 418-704-1112
      • Québec, Canada, G1W 4R4
        • Not yet recruiting
        • Centre de Recherche Saint-Louis inc.
        • Principal Investigator:
          • Catherine Vaillancourt
        • Contact:
          • Phone Number: 418-780-3501
      • Richmond, Canada, V6V 2L1
        • Not yet recruiting
        • Richmond Clinical Trials
        • Contact:
          • Phone Number: 604-373-4954
        • Principal Investigator:
          • Harris Lari
      • Sarnia, Canada, N7T 4X3
        • Not yet recruiting
        • Bluewater Clinical Research Group Inc.
        • Principal Investigator:
          • John O'Mahony
        • Contact:
          • Phone Number: 1 (519) 344-6612
      • Sherbrooke, Canada, J1L 0H8
        • Not yet recruiting
        • Diex Recherche Sherbrooke
        • Contact:
          • Phone Number: 819-346-2887
        • Principal Investigator:
          • Marylene Dussault
      • Surrey, Canada, V3V 0E8
        • Not yet recruiting
        • Centre for Neurology Studies
        • Principal Investigator:
          • Shimi Kang
      • Toronto, Canada, M5G 1K2
        • Not yet recruiting
        • Maple Leaf Research
        • Principal Investigator:
          • Graham Smith
        • Contact:
          • Phone Number: 4164657936
  • China
      • Beijing, China, 100096
        • Not yet recruiting
        • Beijing HuiLongGuan Hospital
        • Principal Investigator:
          • Yunlong Tan
      • Beijing, China, 100088
        • Not yet recruiting
        • Beijing Anding Hospital - Affiliated Capital University of Medical Science
        • Principal Investigator:
          • Gang Wang
      • Changsha, China, 410007
        • Not yet recruiting
        • The Second People's Hospital of Hunan Province
        • Principal Investigator:
          • Xuhui Zhou
      • Chengdu, China, 610036
        • Not yet recruiting
        • The Fourth People's Hospital of Chengdu
        • Principal Investigator:
          • Feiyan Wang
      • Guangzhou, China, 510370
        • Not yet recruiting
        • Guangzhou Brain Hospital
        • Principal Investigator:
          • Yuping Ning
      • Haidian District, China, 100191
        • Not yet recruiting
        • Peking University Sixth Hospital
        • Principal Investigator:
          • Hongyan Zhang
      • Hefei, China, 230061
        • Not yet recruiting
        • Hefei No.4 People's Hospital
        • Principal Investigator:
          • Jianliang Gao
      • Huzhou, China, 313000
        • Not yet recruiting
        • 3rd People's Hospital of Huzhou
        • Principal Investigator:
          • Jianjun Liu
      • Jining, China, 272051
        • Not yet recruiting
        • Shandong Daizhuang Hospital
        • Principal Investigator:
          • Xia Liu
      • Nanchang, China, 330006
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Tao Luo
      • Ningbo, China, 315201
        • Not yet recruiting
        • The Affilicated Kangning Hospital of Ningbo University
        • Principal Investigator:
          • Yongming Xu
      • Shanghai, China, 200030
        • Not yet recruiting
        • Shanghai Mental Health Center
        • Principal Investigator:
          • Wu Hong
      • Shijiazhuang, China, 050031
        • Not yet recruiting
        • The First Hospital of Hebei Medical University
        • Principal Investigator:
          • Cuixia An
      • Suzhou, China, 215003
        • Not yet recruiting
        • Suzhou Guangji Hospital
        • Principal Investigator:
          • Yansong Liu
      • Tianjin, China, 300022
        • Not yet recruiting
        • Tianjin Anding Hospital
        • Principal Investigator:
          • Lina Wang
      • Wuhan, China, 430060
        • Not yet recruiting
        • Renmin Hospital of Wuhan University
        • Principal Investigator:
          • Huiling Wang
      • Wuxi, China, 214151
        • Not yet recruiting
        • Wuxi Mental Health Center
        • Contact:
          • Phone Number: 13358119629
        • Principal Investigator:
          • Zhiqiang Wang
      • Xi'an, China, 710061
        • Not yet recruiting
        • Xi An Mental Health Center
        • Principal Investigator:
          • Huali Lin
      • Xianyang, China, 712000
        • Not yet recruiting
        • Xianyang Hospital of Yan'an University
        • Principal Investigator:
          • Xiaoke Hu
      • Zhumadian, China, 463000
        • Not yet recruiting
        • Zhumadian Psychiatric Hospital
        • Principal Investigator:
          • Hua Guo
  • Germany
      • Aachen, Germany, 52074
        • Not yet recruiting
        • Universitätsklinikum Aachen
        • Principal Investigator:
          • Thomas Frodl
      • Berlin, Germany, 10629
        • Not yet recruiting
        • FutureMeds GmbH
        • Contact:
          • Phone Number: 0049 30 4397410
        • Principal Investigator:
          • Erik Lauterbach
      • Bielefeld, Germany, 33647
        • Not yet recruiting
        • Neurozentrum Bielefeld
        • Contact:
          • Phone Number: 49521443060
        • Principal Investigator:
          • Judith Katzmann
      • Chemnitz, Germany, 09111
        • Not yet recruiting
        • Pharmakologisches Studienzentrum Chemnitz
        • Contact:
          • Phone Number: 0800 - 1600
        • Principal Investigator:
          • Ralf Bodenschatz
      • Mainz, Germany, 55131
        • Not yet recruiting
        • Universitätsmedizin Johannes Gutenberg Universität Mainz
        • Contact:
          • Phone Number: +49 6131 17-2920
        • Principal Investigator:
          • Susanne Englisch
      • Mannheim, Germany, 68165
        • Not yet recruiting
        • ISPG - Institut für Studien zur Psychischen Gesundheit
        • Contact:
          • Phone Number: 4962140046190
        • Principal Investigator:
          • Georg Adler
      • Schwerin, Germany, 19053
        • Not yet recruiting
        • Somni bene
        • Contact:
          • Phone Number: 0049 385207980
        • Principal Investigator:
          • Heike Benes
      • Siegen, Germany, 57076
        • Not yet recruiting
        • ZNS Siegen
        • Contact:
          • Phone Number: 4927131393710
        • Principal Investigator:
          • Eugen Schlegel
  • Greece
      • Argos, Greece, 212 00
        • Not yet recruiting
        • Argolida General Hospital
        • Principal Investigator:
          • Aikaterini Gamvroula
      • Athens, Greece, 115 28
        • Not yet recruiting
        • Aiginiteio University Hospital
        • Principal Investigator:
          • Nikos Stefanis
      • Athens, Greece, 124 62
        • Not yet recruiting
        • Multidisciplinary Mental Health Hospital of Attiki
        • Contact:
          • Phone Number: +302112054278
        • Principal Investigator:
          • Christos Tsopelas
      • Chaïdári, Greece, 124 62
        • Not yet recruiting
        • Attikon General University Hospital
        • Principal Investigator:
          • Nikolaos Smyrnis
      • Stavroupoli, Greece, 564 29
        • Not yet recruiting
        • Multidisciplinary Mental Health Hospital of Thessaloniki
        • Principal Investigator:
          • Vasilios Bozikas
      • Thessaloniki, Greece, 564 29
        • Not yet recruiting
        • Papageorgiou General Hospital of Thessaloniki
        • Principal Investigator:
          • LOUKAS ATHANASIADIS
      • Tripoli, Greece, 221 00
        • Not yet recruiting
        • General Hospital of Tripoli Panarkadiko Evangelistria
        • Principal Investigator:
          • AIKATERINI GEORGOPOULOU
  • Japan
      • Arakawa City, Japan, 116-0014
        • Not yet recruiting
        • Abe Clinic - Arakawa
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tetsuo Abe
      • Chikugo, Japan, 833-0041
        • Not yet recruiting
        • Uematsu Mental Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Ken Uematsu
      • Chiyoda City, Japan, 101-0051
        • Not yet recruiting
        • Jimbocho Mental Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Koji Tada
      • Fukuoka, Japan, 814-0180
        • Not yet recruiting
        • Fukuoka University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hikaru Hori
      • Fukuoka, Japan, 815-0071
        • Not yet recruiting
        • Kokorono Clinic Hirao
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Naoko Kawano
      • Fukushima, Japan, 960-8053
        • Not yet recruiting
        • Horikoshi Mental Somatic Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Sho Horikoshi
      • Ginowan, Japan, 901-2725
        • Not yet recruiting
        • University of the Ryukyus Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yoshikazu Takaesu
      • Hiratsuka, Japan, 259-1205
        • Not yet recruiting
        • Fujimidai Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takafumi Yahoko
      • Karatsu, Japan, 847-0031
        • Not yet recruiting
        • Rainbow and Sea Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Taro Shindo
      • Kawasaki, Japan, 214-0014
        • Not yet recruiting
        • Kishiro Mental Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masaki Kishiro
      • Kumamoto, Japan, 862-0956
        • Not yet recruiting
        • Suizenji Life Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tomohiko Matsuo
      • Kumamoto, Japan, 861-8002
        • Not yet recruiting
        • Yuge Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masahiro Shono
      • Kure, Japan, 737-0023
        • Not yet recruiting
        • Kure Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Wataru Omori
      • Kurume, Japan, 830-0033
        • Not yet recruiting
        • Hirota Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Susumu Hirota
      • Kōtō City, Japan, 135-0047
        • Not yet recruiting
        • Monzen-nakacho Mental Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Junpei Sekiya
      • Meguro-ku, Japan, 152-0012
        • Not yet recruiting
        • Senzoku Psychosomatic Medicine Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Jun Matsushima
      • Nagasaki, Japan, 852-8137
        • Not yet recruiting
        • Arata Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takatoshi Mori
      • Sagamihara, Japan, 252-0303
        • Not yet recruiting
        • Yutaka Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hideo Muraoka
      • Setagaya City, Japan, 154-0004
        • Not yet recruiting
        • Sangenjaya Shinkeika Shinryonaika Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Jun Matsushima
      • Shibuya-ku, Japan, 151-0053
        • Not yet recruiting
        • Maynds Tower Mental Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Nobutoshi Kariya
      • Shirakawa, Japan, 961-0021
        • Not yet recruiting
        • Nanko Kokorono Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Seiji Hongo
      • Tokyo, Japan, 106-0032
        • Not yet recruiting
        • Sakurazaka Clinic SophyAnce
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Haruhito Muto
      • Tokyo, Japan, 162-0843
        • Not yet recruiting
        • Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Seiji Hongo
      • Yamagata, Japan, 990-0045
        • Not yet recruiting
        • Yamagata Sakuracho Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Nobuhiro Yokokawa
      • Yokohama, Japan, 220-0023
        • Not yet recruiting
        • Miki Mental Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kazuhira Miki
      • Yokosuka, Japan, 238-0042
        • Not yet recruiting
        • Shioiri Mental Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kenichi Goto
  • Mexico
      • Chihuahua City, Mexico, 31207
        • Not yet recruiting
        • Scientia Investigacion Clinica S.C.
        • Principal Investigator:
          • Rafael Fernández
      • Guadalajara, Mexico, 44650
        • Not yet recruiting
        • Clinica de Investigacion en Reumatologia y Obesidad S. C.
        • Principal Investigator:
          • Aura Garcia Aguilar
      • Mazatlán, Mexico, 82103
        • Not yet recruiting
        • B&B Investigaciones Medicas S.C.
        • Contact:
          • Phone Number: 52 669 146 3603
        • Principal Investigator:
          • GABRIEL BERNAL
      • Mexico City, Mexico, 04100
        • Not yet recruiting
        • Ketamine Clinic México
        • Contact:
          • Phone Number: 55 15454240
        • Principal Investigator:
          • MANUEL RUIZ FLORES
      • Mexico City, Mexico, 07000
        • Not yet recruiting
        • GabiPros
        • Principal Investigator:
          • Miguel Herrera
      • Morelia, Mexico, 58260
        • Not yet recruiting
        • Centro de Investigacion Clinica Chapultepec
        • Principal Investigator:
          • Misael Tapia Orozco
      • Mérida, Mexico, 97070
        • Not yet recruiting
        • Medical Care and Research SA de CV
        • Principal Investigator:
          • Enrique Lara González
      • Veracruz, Mexico, 91900
        • Not yet recruiting
        • Arké SMO S.A de C.V
        • Principal Investigator:
          • Samantha Aranda Pegueros
      • Zapopan, Mexico, 45170
        • Not yet recruiting
        • Instituto Jalisciense de Salud Mental
        • Principal Investigator:
          • Sergio Villasenor-Bayardo
  • Poland
      • Bialystok, Poland, 15-756
        • Not yet recruiting
        • Podlaskie Centrum Psychogeriatrii
        • Principal Investigator:
          • Jacek Dobryniewski
        • Contact:
          • Phone Number: 48667980448
      • Bielsko-Biala, Poland, 43-300
        • Not yet recruiting
        • MentalMEDIC
        • Contact:
          • Phone Number: +48 662 234 338
        • Principal Investigator:
          • Grzegorz Giemza
      • Gdansk, Poland, 80-546
        • Not yet recruiting
        • Centrum Badan Klinicznych PI-House sp. z o.o.
        • Contact:
          • Phone Number: 48587192222
        • Principal Investigator:
          • Hanna Badzio-Jagiello
      • Krakow, Poland, 31-559
        • Not yet recruiting
        • Diamond Clinic
        • Principal Investigator:
          • Barbara Rewerska
        • Contact:
          • Phone Number: + 48 696 049 029
      • Leszno, Poland, 64-100
        • Not yet recruiting
        • NZOZ Psychiatrycznej Mentis
        • Principal Investigator:
          • Bartlomiej Krzewinski
      • Lublin, Poland, 20-109
        • Not yet recruiting
        • Centrum Medyczne Luxmed
        • Principal Investigator:
          • Dariusz Malicki
      • Poznan, Poland, 60-192
        • Not yet recruiting
        • Private Practice - Dr. Małgorzata Wojtanowska-Bogacka
        • Principal Investigator:
          • Malgorzata Wojtanowska-Bogacka
      • Szczecin, Poland, 70-111
        • Not yet recruiting
        • Centrum Medyczne Euromedis
        • Principal Investigator:
          • Adam Lopuszko
      • Warsaw, Poland, 02-798
        • Not yet recruiting
        • Medical Concierge Centrum Medyczne
        • Principal Investigator:
          • Marcin Wojnar
      • Wroclaw, Poland, 50-414
        • Not yet recruiting
        • Centrum Medyczne Ginemedica
        • Contact:
          • Phone Number: +48697555434
        • Principal Investigator:
          • Katarzyna Okopien
      • Zabrze, Poland, 41-807
        • Not yet recruiting
        • ClinHouse Centrum Medyczne
        • Principal Investigator:
          • Joanna Moszant
  • Puerto Rico
      • Bayamón, Puerto Rico, 00961
        • Not yet recruiting
        • SCB Research Center
        • Principal Investigator:
          • William Julio
        • Contact:
          • Phone Number: (787) 798-4592
  • South Korea
      • Ansan-si, South Korea, 15355
        • Not yet recruiting
        • Korea University Ansan Hospital
        • Contact:
          • Phone Number: 82314127617
        • Principal Investigator:
          • Cheolmin Shin
      • Gwangju, South Korea, 61469
        • Not yet recruiting
        • Chonnam National University Hospital
        • Principal Investigator:
          • JAE-MIN KIM
      • Jeju City, South Korea, 63241
        • Not yet recruiting
        • Jeju National University Hospital
        • Principal Investigator:
          • JOON HYUK PARK
      • Seoul, South Korea, 03080
        • Not yet recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • YONGMIN AHN
      • Seoul, South Korea, 03722
        • Not yet recruiting
        • Severance Hospital, Yonsei University Health System
        • Principal Investigator:
          • Chun Il Park
      • Seoul, South Korea, 05030
        • Not yet recruiting
        • Konkuk University Medical Center
        • Contact:
          • Phone Number: 82-2-2030-7699
        • Principal Investigator:
          • Hongjun Jeon
      • Seoul, South Korea, 06591
        • Not yet recruiting
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital
        • Principal Investigator:
          • Junhee Lee
      • Seoul, South Korea, 05505
        • Not yet recruiting
        • Asan Medical Center
        • Principal Investigator:
          • Christopher Park
      • Seoul, South Korea, 06351
        • Not yet recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Hong Jin Jeon
  • Spain
      • Barcelona, Spain, 08036
        • Not yet recruiting
        • Hospital Clinic De Barcelona
        • Contact:
          • Phone Number: 93.2275400
        • Principal Investigator:
          • Eduard Vieta
      • Barcelona, Spain, 08041
        • Not yet recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Principal Investigator:
          • Narcis Cardoner
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Josep-Antoni Ramos-Quiroga
      • Barcelona, Spain, 08025
        • Not yet recruiting
        • Institucion Hosp Hestia Palau
        • Contact:
          • Phone Number: 0034 635586700
        • Principal Investigator:
          • Elena Ros Cucurull
      • Barcelona, Spain, 08003
        • Not yet recruiting
        • Parc de Salut Mar - Hospital del Mar
        • Contact:
          • Phone Number: +34932483175
        • Principal Investigator:
          • Victor Pérez-sola
      • Madrid, Spain, 28031
        • Not yet recruiting
        • Hospital Universitario Infanta Leonor
        • Principal Investigator:
          • Javier Quintero
        • Contact:
          • Phone Number: +34619231150
      • Oviedo, Spain, 33011
        • Not yet recruiting
        • Centro de Atención Integral La Corredoria
        • Principal Investigator:
          • Pilar Sáiz
      • Salamanca, Spain, 37005
        • Not yet recruiting
        • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
        • Contact:
          • Phone Number: 34639754620
        • Principal Investigator:
          • ANGEL MONTEJO
      • Vitoria-Gasteiz, Spain, 01009
        • Not yet recruiting
        • Hospital Universitario de Araba (HUA)- Hospital Txagorritxu
        • Principal Investigator:
          • Iñaki Zorrilla Martínez
      • Zamora, Spain, 49021
        • Not yet recruiting
        • Complejo Asistencial de Zamora
        • Contact:
          • Phone Number: 669462622
        • Principal Investigator:
          • Manuel Franco-Martin
  • Taiwan
      • Keelung, Taiwan, 204
        • Not yet recruiting
        • Keelung Chang Gung Memorial Hospital
        • Principal Investigator:
          • Chih-Ken Chen
      • Taichung, Taiwan, 402
        • Not yet recruiting
        • Chung Shan Medical University Hospital
        • Principal Investigator:
          • Po-Chung Ju
      • Tainan, Taiwan, 704
        • Not yet recruiting
        • National Cheng Kung University Hospital
        • Contact:
          • Phone Number: +886-6-2353535ext.5213
        • Principal Investigator:
          • Yen Kuang Yang
      • Taipei, Taiwan, 11217
        • Not yet recruiting
        • Taipei Veterans General Hospital
        • Principal Investigator:
          • Ya-Mei Bai
      • Taipei, Taiwan, 10002
        • Not yet recruiting
        • National Taiwan University Hospital
        • Contact:
          • Phone Number: +886-23123456 ext 267991
        • Principal Investigator:
          • I-Ming Chen
      • Taipei, Taiwan, 112
        • Not yet recruiting
        • Cheng Hsin General Hospital
        • Contact:
          • Phone Number: 0228264400 ext3502
        • Principal Investigator:
          • Tung Ping Su
      • Taipei, Taiwan, 110
        • Not yet recruiting
        • Taipei Medical University Hospital
        • Contact:
          • Phone Number: 0970405254
        • Principal Investigator:
          • Kuo-Hsuan Chung
      • Taoyuan, Taiwan, 333
        • Not yet recruiting
        • Chang Gung Medical Foundation-Linkou Branch
        • Principal Investigator:
          • Huang-Li Lin
  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
        • Not yet recruiting
        • Edinburgh Royal Infirmary
        • Contact:
          • Phone Number: 07958777103
        • Principal Investigator:
          • Donald MacIntyre
      • Exeter, United Kingdom, EX2 5AF
        • Recruiting
        • Devon Partnership Trust
        • Contact:
          • Phone Number: 07973 831470
        • Principal Investigator:
          • Merryn Anderson
      • Glasgow, United Kingdom, G51 4TF
        • Not yet recruiting
        • Queen Elizabeth University Hospital
        • Contact:
          • Phone Number: (+44) 0141 232 7600
        • Principal Investigator:
          • Nagore Penades
      • London, United Kingdom, SE5 8AZ
        • Not yet recruiting
        • The Maudsley Hospital
        • Principal Investigator:
          • Allan Young
      • London, United Kingdom, W1G 8DR
        • Recruiting
        • Clerkenwell Health - London - Welbeck Street
        • Principal Investigator:
          • Alishah Suleman
        • Contact:
          • Phone Number: 07411606926
      • Nottingham, United Kingdom, NG7 2UH
        • Not yet recruiting
        • Queen's Medical Centre, Nottingham University Hospitals
        • Principal Investigator:
          • Neil Nixon
      • Oxford, United Kingdom, OX4 1XB
        • Recruiting
        • St Bartholomew's Medical Centre
        • Contact:
          • Phone Number: 01865242 334
        • Principal Investigator:
          • Carol Doan
      • Oxford, United Kingdom, OX3 7JX
        • Not yet recruiting
        • Warneford Hospital
        • Principal Investigator:
          • Riccardo De Giorgi
      • Penzance, United Kingdom, TR18 3DX
        • Recruiting
        • Atlantic Medical
        • Contact:
          • Phone Number: 01736363741
        • Principal Investigator:
          • John Ryan
      • Rotherham, United Kingdom, S61 1AH
        • Recruiting
        • Woodstock Bower Surgery
        • Contact:
          • Phone Number: 07551985998
        • Principal Investigator:
          • Shahbaz Ali
  • United States
    • California
      • Moorpark, California, United States, 93021
        • Not yet recruiting
        • Accellacare - Moorpark
        • Contact:
          • Phone Number: 747-998-0394
        • Principal Investigator:
          • Arjun Reyes
      • Orange, California, United States, 92866
        • Recruiting
        • ATP Clinical Research
        • Principal Investigator:
          • Gustavo Alva
        • Contact:
          • Phone Number: 9493545353
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Not yet recruiting
        • Yale University School of Medicine
        • Principal Investigator:
          • Mohini Ranganathan
        • Contact:
          • Phone Number: 2039325711
    • Florida
      • Hollywood, Florida, United States, 33024
        • Not yet recruiting
        • Encore Medical Research
        • Contact:
          • Phone Number: 954-400-1725
        • Principal Investigator:
          • Alen Hidalgo
      • Maitland, Florida, United States, 32751
        • Not yet recruiting
        • K2 Medical Research - Maitland
        • Principal Investigator:
          • Sejal Patel
      • Miami Gardens, Florida, United States, 33014
        • Recruiting
        • Life Medical Research Group Corp
        • Contact:
          • Phone Number: 305-705-4111
        • Principal Investigator:
          • Rafael Conte
      • Miami Lakes, Florida, United States, 33016-1518
        • Not yet recruiting
        • Floridian Clinical Research, LLC
        • Contact:
          • Phone Number: 305-330-9977
        • Principal Investigator:
          • Hortensia Valeron
      • Naples, Florida, United States, 34116
        • Not yet recruiting
        • CLA Research
        • Principal Investigator:
          • Evelia Iglesias
        • Contact:
          • Phone Number: 2398378818
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Optimal Research Sites
        • Contact:
          • Phone Number: 3862185911
        • Principal Investigator:
          • Antonio Cubano
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Charter Research - Orlando
        • Principal Investigator:
          • Jorel Martinez
      • Tampa, Florida, United States, 33634
        • Not yet recruiting
        • K2 Medical Research - Tampa
        • Principal Investigator:
          • Kelley Wilson
        • Contact:
          • Phone Number: 813.800.5252
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • CenExel iResearch, LLC
        • Contact:
          • Phone Number: 404-537-1281
        • Principal Investigator:
          • Saundra Maass-Robinson
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health Neuroscience Center
        • Contact:
          • Phone Number: 3179637300
        • Principal Investigator:
          • Stephen Strakowski
    • Iowa
      • Waterloo, Iowa, United States, 50701
        • Not yet recruiting
        • Cedar Valley Medical Specialists
        • Contact:
          • Phone Number: 319-888-8270
        • Principal Investigator:
          • James Poock
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Recruiting
        • Pharmasite Research, Inc.
        • Principal Investigator:
          • Sarah Herts
        • Contact:
          • Phone Number: 410 602-1440
    • Massachusetts
      • Boston, Massachusetts, United States, 02116
        • Recruiting
        • Adams Clinical Boston
        • Principal Investigator:
          • Dyanna Domilici
        • Contact:
          • Phone Number: (617) 744-8542
      • Watertown, Massachusetts, United States, 02472
        • Recruiting
        • Adams Clinical Watertown
        • Contact:
          • Phone Number: 6177448542
        • Principal Investigator:
          • Daniel Rutrick
    • Michigan
      • Troy, Michigan, United States, 48098
        • Not yet recruiting
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
        • Contact:
          • Phone Number: 248-312-0025
        • Principal Investigator:
          • Neil Fraser
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Not yet recruiting
        • Arch Clinical Trials
        • Contact:
          • Phone Number: 314-282-3521
        • Principal Investigator:
          • Junaid Syed
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Vector Clinical Trials
        • Principal Investigator:
          • Ann Childress
        • Contact:
          • Phone Number: 7027500000
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Adams Clinical Harlem
        • Principal Investigator:
          • Rachel Noone
        • Contact:
          • Phone Number: 917-423-67697
    • Oregon
      • Portland, Oregon, United States, 97210
        • Not yet recruiting
        • Summit Headlands
        • Principal Investigator:
          • Beal Essink
        • Contact:
          • Phone Number: 5033143900
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Recruiting
        • Suburban Research Associates
        • Principal Investigator:
          • Kristen Dopf
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • Penn Medicine: University of Pennsylvania Health System
        • Principal Investigator:
          • yvette sheline
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Not yet recruiting
        • K2 Medical Research - East Providence
        • Contact:
          • Phone Number: 401-435-8950
        • Principal Investigator:
          • john stoukides
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Not yet recruiting
        • Circle Clinical Research
        • Principal Investigator:
          • Sophie Two Hawk
        • Contact:
          • Phone Number: 6052151159
    • Texas
      • DeSoto, Texas, United States, 75115
        • Recruiting
        • Adams Clinical Dallas
        • Principal Investigator:
          • Benji Kurian
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Re:Cognition Health - Fort Worth
        • Principal Investigator:
          • Lili Meisamy
      • Shavano Park, Texas, United States, 78231
        • Not yet recruiting
        • Consano Clinical Research, LLC
        • Contact:
          • Phone Number: 210-545-4900
        • Principal Investigator:
          • Michelle Welch
    • Utah
      • Clinton, Utah, United States, 84015
        • Recruiting
        • Alpine Research Organization
        • Principal Investigator:
          • Michael Roundy
        • Contact:
          • Phone Number: 801-928-3292
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Not yet recruiting
        • Re:Cognition Health
        • Principal Investigator:
          • Scott Williams
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center
        • Principal Investigator:
          • Arun Arora
        • Contact:
          • Phone Number: 4254530404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Meet the diagnostic criteria for major depressive disorder
  • Are on a stable standard of care medication for major depressive disorder

  • Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as

    • self-inject study intervention
    • store and use the provided blinded study intervention, as directed
    • maintain electronic and paper study diaries, as applicable, and
    • complete the required questionnaires

Exclusion Criteria:

  • Have a lifetime history or current diagnosis of the following:

    • schizophrenia or other psychotic disorder
    • bipolar disorder
    • borderline personality disorder, or
    • any eating disorder.

  • Have type 1 diabetes mellitus, or a history of

    • ketoacidosis, or
    • hyperosmolar state or coma.
  • Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
  • Are actively suicidal or deemed a significant risk for suicide
  • Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered SC + SoC.
Drug: Placebo
Administered SC
Experimental: Brenipatide Dose 1
Brenipatide administered subcutaneously (SC) + standard of care (SoC).
Drug: Brenipatide
Administered SC
Other Names:
  • LY3537031
Experimental: Brenipatide Dose 2
Brenipatide administered SC + SoC
Drug: Brenipatide
Administered SC
Other Names:
  • LY3537031
Experimental: Brenipatide Dose 3
Brenipatide administered SC + SoC
Drug: Brenipatide
Administered SC
Other Names:
  • LY3537031

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Relapse Defined as the Number of Days from Randomization to Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD)
Time Frame: From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months
From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2
Time Frame: Baseline, Up to at Least 6 Months
Baseline, Up to at Least 6 Months
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time Frame: Baseline, Up to at Least 6 Months
Baseline, Up to at Least 6 Months
Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score
Time Frame: Baseline, Up to at Least 6 Months
Baseline, Up to at Least 6 Months
Change from Baseline in Patient Global Impression of Severity (PGI-S)
Time Frame: Baseline, Up to at Least 6 Months
Baseline, Up to at Least 6 Months
Change from Baseline in Generalized Anxiety Disorder (GAD) - 7 Total Score
Time Frame: Baseline, Up to at Least 6 Months
Baseline, Up to at Least 6 Months
Change from Baseline in Patient Rated Symptom and Disease Severity
Time Frame: Baseline, Up to at least 6 months
Baseline, Up to at least 6 months
Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score
Time Frame: Baseline, Up to at Least 6 Months
Baseline, Up to at Least 6 Months
Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2 and on an Atypical Antipsychotic
Time Frame: Baseline, Up to at Least 6 Months
Baseline, Up to at Least 6 Months
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Time Frame: Predose Up to at Least 6 Months
Predose Up to at Least 6 Months
Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADA)
Time Frame: Baseline Up to at Least 6 Months
Baseline Up to at Least 6 Months
Change from Baseline in Patient-Reported Outcomes Measurement Information Systems (PROMIS) Short Form
Time Frame: Baseline, Up to at Least 6 Months
Baseline, Up to at Least 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27363
  • 2025-522308-25-00 (Ctis)
  • J2S-MC-GZMH (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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