Depressive Disorder, MajorPhase 3RENEW-MDD- 2NCT07775300
A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
A Phase 3 study testing Brenipatide in people with Depressive Disorder, Major, run by Eli Lilly and Company at 170 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Brenipatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 170 sitesin 15 countries
- Study dates
- 14 Aug 2026to Feb 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria for major depressive disorder
- Are on 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
Who cannot join
- Have a lifetime history or current diagnosis of the following:
- schizophrenia spectrum or other psychotic disorder
- bipolar disorder
- borderline personality disorder, or
- any eating disorder
- Have type 1 diabetes mellitus, or a history of:
Show all 11Show fewer
- 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
Trial locations and contacts
170 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
170 sites in 15 countries
United States34 sites, 34 recruiting
- Recruiting
JEM Research Institute
Atlantis, Florida, 33462
561-968-2933
Linda Pao
- Not yet recruiting
FutureSearch Trials of Neurology
Austin, Texas, 78731
512-380-9925
Craig Franke
- Recruiting
Pharmasite Research, Inc.
Baltimore, Maryland, 21208
410-602-1440
Sarah Herts
- Recruiting
Gadolin Research
Beaumont, Texas, 77702
409-331-6040
John Fowler
- Recruiting
Northwest Clinical Research Center
Bellevue, Washington, 98007
425-453-0404
Wisam Al jumaili
- Recruiting
University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama, 35294
205-934-2484
Matthew Macaluso
- Recruiting
Adams Clinical Boston
Boston, Massachusetts, 02116
Darin Dougherty
- Recruiting
Bradenton Research Center, Inc.
Bradenton, Florida, 34205
941-708-0005
Eric Folkens
- Recruiting
Key Clinical Research
Bradenton, Florida, 34207
941-538-5825
Nicholas Weber
- Recruiting
Charter Research - Chicago
Chicago, Illinois, 60618
Derrick Farmer
- Not yet recruiting
CenExel iResearch, LLC
Decatur, Georgia, 30030
404-537-1281
Saundra Maass-Robinson
- Recruiting
Adams Clinical Dallas
DeSoto, Texas, 75115
Benji Kurian
- Not yet recruiting
The University of Texas Rio Grande Valley
Harlingen, Texas, 78550
956-296-5527
Ihsan Salloum
- Recruiting
NextPhase Research Florida - Hollywood
Hollywood, Florida, 33024
Peter Ventre
- Recruiting
Irvine Clinical Research
Irvine, California, 92614
949-753-1663
Elly Lee
- Recruiting
Olympus Clinical Research
Katy, Texas, 77450
346-397-4457
Benjamin Wowo
- Not yet recruiting
Healthy Brain Clinic
Long Beach, California, 90804
562-606-5999
Dung Trinh
- Not yet recruiting
Miami Jewish health
Miami, Florida, 33137
305-514-8503
Marc Agronin
- Recruiting
Quantix Research - Miami - Southwest 72nd Street
Miami, Florida, 33173
Sergio Jaramillo
- Recruiting
Diverse Clinical Research
Miami, Florida, 33175
Georgette DeJesus
- Recruiting
CLA Research
Naples, Florida, 34116
239-837-8818
Evelia Iglesias
- Recruiting
Oakland Clinical
Oakland, California, 94609
T. Richard Parenteau
- Recruiting
Be Well Clinical Studies - Omaha
Omaha, Nebraska, 68144
402-261-7093
John Puente
- Recruiting
Adams Clinical Philadelphia
Philadelphia, Pennsylvania, 19104
Cassie Blanchard
- Recruiting
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Yvette Sheline
- Recruiting
NoesisPharma, LLC
Phoenix, Arizona, 85028
John Prater
- Recruiting
Boeson Research - Provo
Provo, Utah, 84604
385-392-2200
Jason Andersen
- Recruiting
AGILE Clinical Research Trials, LLC
Sandy Springs, Georgia, 30328
Vasundhara Cheekati
- Recruiting
Adams Clinical Bronx
The Bronx, New York, 10461
Shama Farooq
- Recruiting
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098
248-312-0025
Neil Fraser
- Recruiting
Concierge Clinical Trials
Valley Village, California, 91607
Neal Cutler
- Recruiting
Adams Clinical Watertown
Watertown, Massachusetts, 02472
617-744-8542
Stephanie Ellickson
- Recruiting
Suburban Research Associates
West Chester, Pennsylvania, 19380
Omer Abdullah
- Recruiting
Health Synergy Clinical Research
West Palm Beach, Florida, 33407
786-863-3325
Mohammad Nisar
Japan21 sites, 21 recruiting
- Not yet recruiting
Medical corporation Shinseikai Kaku Mental Clinic
Fukuoka, 810-0022
81120023812
Hiromitsu Kaku
- Not yet recruiting
Kuramitsu Hospital
Fukuoka, 819-0037
81120023812
Noriko Tamaru
- Not yet recruiting
UNB Sumiyoshi Jinjamae Clinic
Hakata-Ku, 812-0018
81120023812
Naoya Oribe
- Not yet recruiting
Hinotoyoda Cocoro Clinic
Hino, 191-0062
81120023812
Yuichiro Tsutsumi
- Not yet recruiting
Rainbow and Sea Hospital
Karatsu, 847-0031
81120023812
Taro Shindo
- Not yet recruiting
Kishiro Mental Clinic
Kawasaki, 214-0014
81120023812
Masaki Kishiro
- Not yet recruiting
Hiiragi Kokoro Clinic - Kokurain
Kitakyushu, 802-0001
81120023812
TASUKU NISHIYAMA
- Not yet recruiting
Juntendo Koshigaya Hospital
Koshigaya, 343-0032
81120023812
baba hajime
- Not yet recruiting
Monzen-nakacho Mental Clinic
Kōtō City, 135-0047
81120023812
Junpei Sekiya
- Not yet recruiting
National Hospital Organization Shimofusa Psychiatric Medical Center
MIdori-ku, Chiba-shi, 266-0007
81120023812
Teruki Koizumi
- Not yet recruiting
Tokyo Nakano Mental Clinic
Nakano City, 164-0001
81120023812
Hironobu Ohtsuchi
- Not yet recruiting
Watanabe Clinic
Osaka, 541-0043
81120023812
Kenichi Watanabe
- Not yet recruiting
Yutaka Clinic
Sagamihara, 252-0303
81120023812
Hideo Muraoka
- Not yet recruiting
Kitasato University Hospital
Sagamihara, 252-0375
81120023812
Hiroyuki Muraoka
- Not yet recruiting
Maynds Tower Mental Clinic
Shibuya-ku, 151-0053
81120023812
Nobutoshi Kariya
- Not yet recruiting
Etoh Mentalclinic Meguro
Shinagawa City, 141-0021
81120023812
Akemi Eto
- Not yet recruiting
Tokumoto Komorebi Clinic
Suita, 564-0063
81120023812
TAKAHIRO TOKUMOTO
- Not yet recruiting
Sangenjaya Nakamura Mental Clinic
Tokyo, 154-0004
81120023812
Satoshi Nakamura
- Not yet recruiting
Ikebukuro Olive Mental Clinic
Toshima City, 170-0013
81120023812
Sachie Matsushima
- Not yet recruiting
Miki Mental Clinic
Yokohama, 220-0023
81120023812
Kazuhira Miki
- Not yet recruiting
Yokohama Mental Clinic Totsuka
Yokohama, 244-0816
81120023812
Takashi Hayama
Spain12 sites, 12 recruiting
- Not yet recruiting
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003
+34932483175
Victor Pérez-sola
- Not yet recruiting
Institucion Hosp Hestia Palau
Barcelona, 08025
0034 635586700
Elena Ros Cucurull
- Not yet recruiting
Parc Sanitari Sant Joan de Déu
Barcelona, 08029
+34 933249600
Óscar Soto Angona
- Not yet recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
93.2275400
Eduard Vieta
- Not yet recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Narcis Cardoner
- Not yet recruiting
EAP Osona Sud - Alt Congost S.L.P
Centelles, 08540
(+34) 93 881 04 85
Silvia Narejos Perez
- Not yet recruiting
Hospital Universitario Infanta Leonor
Madrid, 28031
+34619231150
Javier Quintero
- Not yet recruiting
Centro de Salud Mental (CSM) La Corredoria
Oviedo, 33011
Pilar Sáiz
- Not yet recruiting
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37005
34639754620
ANGEL MONTEJO
- Not yet recruiting
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
Seville, 41003
+ 34 954709183
Alberto Aliaga Verdugo
- Not yet recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
+34 671 59 66 75
Benedicto Crespo-Facorro
- Not yet recruiting
Complejo Asistencial de Zamora
Zamora, 49021
Juan Antonio Mellado
Brazil11 sites, 11 recruiting
- Not yet recruiting
Instituto de Pesquisa clinica de Campinas
Campinas, 13060-080
Alexandre Comandule
- Not yet recruiting
Cline Research Center
Curitiba, 80030-480
+554130273930
Silmara Leite
- Not yet recruiting
Clínica Neurológica
Joinville, 89202190
55 47 3451 2596
Alexandre Longo
- Not yet recruiting
Instituto Méderi de Pesquisa e Saúde
Passo Fundo, 99010-120
55 54 3581 1831
Jacson Hubner
- Not yet recruiting
Hospital das Clínicas - UFPE
Recife, 50670-420
Hugo Melo
- Not yet recruiting
Centro Multidisciplinar de Estudos Clinicos
São Bernardo do Campo, 09715-090
Flavia Pinto
- Not yet recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, 15090000
+55 17 3201-5054
Gerardo Araujo-Filho
- Recruiting
PSEG Centro de Pesquisa Clínica
São Paulo, 04038-002
Paulo Victor Sgobbi de Souza
- Not yet recruiting
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010
Lauro Goncalves
- Not yet recruiting
CEDOES
Vitória, 29055450
+55 27 99790-0139
Rafael Riva
- Not yet recruiting
Integral Pesquisa e Ensino
Votuporanga, 15500-269
55 17 3426-6090
Kamila Carvalho
Poland11 sites, 11 recruiting
- Not yet recruiting
Podlaskie Centrum Psychogeriatrii
Bialystok, 15-756
48667980448
Jacek Dobryniewski
- Not yet recruiting
MentalMEDIC
Bielsko-Biala, 43-300
+48 662 234 338
Grzegorz Giemza
- Recruiting
IN VIVO
Bydgoszcz, 85-048
888455614
Anna Kowal Skimina
- Not yet recruiting
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, 80-546
Grzegorz Kuczynski
- Not yet recruiting
Diamond Clinic
Krakow, 31-559
+ 48 696 049 029
Barbara Rewerska
- Not yet recruiting
NZOZ Psychiatrycznej Mentis
Leszno, 64-100
Bartlomiej Krzewinski
- Not yet recruiting
Santa Familia PTG Lodz
Lodz, 90-302
Elzbieta Wagenknecht
- Recruiting
Nowy Szpital w Olkuszu
Olkusz, 32-300
Katarzyna Urbanczyk-Losien
- Not yet recruiting
Private Practice - Dr. Małgorzata Wojtanowska-Bogacka
Poznan, 60-192
Malgorzata Wojtanowska-Bogacka
- Not yet recruiting
Centrum Medyczne Ginemedica
Wroclaw, 50-414
+48697555434
Katarzyna Okopien
- Not yet recruiting
Clinhouse Centrum Medyczne
Zabrze, 41-807
Joanna Moszant
Canada10 sites, 10 recruiting
- Not yet recruiting
CaRe Clinic
Calgary, T2N 4L7
1-587-955-3401
Payman Hajiazim
- Not yet recruiting
Kelowna Health and Memory Centre
Kelowna, V1Y 5A8
Eugene Okorie
- Not yet recruiting
Providence Care
Kingston, K7L 4X3
6135444900
Roumen Milev
- Not yet recruiting
Alpha Recherche Clinique - Lévis
Lévis, G6V 0C9
418-380-1112
Steeve Kwan Tat
- Not yet recruiting
AMNDX
Markham, L3R 1A3
647-984-8882
Alan Lowe
- Not yet recruiting
Malton Medical Group
Mississauga, L4T 4J2
905-677-4200
Brian Zidel
- Not yet recruiting
Alpha Recherche Clinique
Québec, G2J 0C4
418-704-1112
Raphael Poulin-Robitaille
- Not yet recruiting
ALPHA Recherche Clinique
Québec, G3K 2P8
418-847-1112
Xavier Mignault
- Not yet recruiting
Richmond Clinical Trials
Richmond, V6V 2L1
604-373-4954
Harris Lari
- Not yet recruiting
Research, Innovation, Science and Excellence (RISE) Institute
Toronto, L5L 1W8
4166695279
Roger McIntyre
China10 sites, 10 recruiting
- Recruiting
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing, 100088
Gang Wang
- Recruiting
Chaohu Hospital of Anhui Medical University
Chaohu, 238001
Kai Zhang
- Recruiting
Shandong Mental Health Center
Jinan, 250012
Xu Chen
- Recruiting
Linfen Central Hospital
Linfen, 041000
Yan Dong
- Recruiting
Shanghai Tongji Hospital
Shanghai, 200065
Yuan Shen
- Recruiting
Suzhou Guangji Hospital
Suzhou, 215003
Chuanwei Li
- Not yet recruiting
Tianjin Anding Hospital
Tianjin, 300022
Lina Wang
- Recruiting
The Affiliated Kangning Hospital of Wenzhou Medical University
Wenzhou, 325007
Wei Tang
- Recruiting
Wuhu Hospital of Beijing Anding hospital
Wuhu, 242407
Changqing Hu
- Recruiting
Zhenjiang Mental Health Center
Zhenjiang, 212000
Bei Zhao
Mexico10 sites, 10 recruiting
- Not yet recruiting
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207
Rafael Fernández
- Not yet recruiting
Scientia Investigacion Clinica Tj
Ciudad de Tijuana, 22105
Alejandro Flores Velasco
- Not yet recruiting
Investigación Clínica Cuernavaca, S.C.
Cuernavaca, 62448
Azucena Hernández Aragón
- Not yet recruiting
Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
Culiacán, 80230
Maria Moya Palazuelos
- Not yet recruiting
Medical Care and Research SA de CV
Mérida, 97070
Enrique Lara González
- Not yet recruiting
RM Pharma Specialists
Mexico City, 03100
Lucia Sanchez
- Not yet recruiting
Ketamine Clinic México
Mexico City, 04100
55 15454240
MANUEL RUIZ FLORES
- Not yet recruiting
Human Science Research Trials
Mexico City, 14050
5556162095
Angel Ruiz Chow
- Not yet recruiting
FAICIC S. de R.L. de C.V.
Veracruz, 91900
2299327808
Carlos Ancheyta
- Not yet recruiting
Núcleo de Investigación Médica Sur de Guadalajara
Zapopan, 45070
Jessica Rosas Escobar
United Kingdom10 sites, 10 recruiting
- Not yet recruiting
Bodmin Community Hospital
Bodmin, PL31 2QT
01637 850002
Nicholas Jacobsen
- Not yet recruiting
Edinburgh Royal Infirmary
Edinburgh, EH16 4SA
0131 441 8639
Alasdair Rooney
- Not yet recruiting
Devon Partnership Trust
Exeter, EX2 5AF
07973 831470
Merryn Anderson
- Not yet recruiting
Queen Elizabeth University Hospital
Glasgow, G51 4TF
(+44) 0141 232 7600
Nagore Penades
- Not yet recruiting
Avrin - Liverpool
Liverpool, L24 7RB
01512451709
Fahimeh Moslemi
- Recruiting
NeuroClnx
Motherwell, ML1 4UF
01419480206
Jennifer Lynch
- Recruiting
St Bartholomew's Medical Centre
Oxford, OX4 1XB
01865242 334
Carol Doan
- Not yet recruiting
Atlantic Medical
Penzance, TR18 3DX
01736363741
John Ryan
- Recruiting
Ascend Clinical Research
Reading, RG7 8PA
Dani Hristova
- Recruiting
Woodstock Bower Surgery
Rotherham, S61 1AH
07551985998
Shahbaz Ali
Australia9 sites, 9 recruiting
- Not yet recruiting
Ramsay Clinic New Farm
Brisbane, 4005
James Scott
- Not yet recruiting
Paratus Clinical Research Canberra
Bruce, 2617
Paul Fitzgerald
- Not yet recruiting
NeuroCentrix
Carlton, 3053
61395460009
David Barton
- Not yet recruiting
Lyell McEwin Hospital
Elizabeth Vale, 5112
0881829554
Dennis Liu
- Not yet recruiting
Barwon Health
Geelong, 3220
Roth Trisno
- Not yet recruiting
Multidisciplinary Alfred Psychiatry Research Centre
Melbourne, 3004
Rebecca Ho
- Not yet recruiting
Ramsay Clinic Albert Road
Melbourne, 3004
Malcolm Hopwood
- Not yet recruiting
Toowoomba Hospital
Toowoomba, 4350
Vikas Garg
- Not yet recruiting
Westmead Hospital
Westmead, 2145
Vlasios Brakoulias
South Korea9 sites, 9 recruiting
- Not yet recruiting
Korea University Ansan Hospital
Ansan-si, 15355
Saim Jung
- Not yet recruiting
Chonnam National University Hospital
Gwangju, 61469
JAE-MIN KIM
- Not yet recruiting
Jeju National University Hospital
Jeju City, 63241
JOON HYUK PARK
- Not yet recruiting
Seoul National University Hospital
Seoul, 03080
YONGMIN AHN
- Not yet recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Chun Il Park
- Not yet recruiting
Konkuk University Medical Center
Seoul, 05030
82-2-2030-7699
Hongjun Jeon
- Not yet recruiting
Asan Medical Center
Seoul, 05505
Christopher Park
- Not yet recruiting
Samsung Medical Center
Seoul, 06351
Hong Jin Jeon
- Not yet recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591
Junhee Lee
Taiwan8 sites, 8 recruiting
- Not yet recruiting
Keelung Chang Gung Memorial Hospital
Keelung, 204
Chih-Ken Chen
- Not yet recruiting
Chung Shan Medical University Hospital
Taichung, 402
Po-Chung Ju
- Not yet recruiting
Taichung Veterans General Hospital
Taichung, 407
+886936323001
Shiow Wen Yang
- Not yet recruiting
National Cheng Kung University Hospital
Tainan, 704
+886-6-2353535ext.5213
Yen Kuang Yang
- Not yet recruiting
National Taiwan University Hospital
Taipei, 10002
+886-23123456 ext 267991
I-Ming Chen
- Not yet recruiting
Taipei Veterans General Hospital
Taipei, 11217
Ya-Mei Bai
- Not yet recruiting
Cheng Hsin General Hospital
Taipei, 112
0228264400 ext3502
Tung Ping Su
- Not yet recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Huang-Li Lin
Germany6 sites, 6 recruiting
- Not yet recruiting
FutureMeds Berlin
Berlin, 10629
+49 30 43 97 410
Sascha Oehm
- Recruiting
Charite Universitätsmedizin Berlin Campus Benjamin Franklin
Berlin, 12203
004930450517774
Christian Otte
- Not yet recruiting
Pharmakologisches Studienzentrum Chemnitz
Chemnitz, 09111
0800 - 1600
Ralf Bodenschatz
- Not yet recruiting
Klinische Forschung Hamburg
Hamburg, 20253
49404607630
Christian Deckert
- Not yet recruiting
Universitätsklinikum Leipzig
Leipzig, 04103
Maria Strauss
- Not yet recruiting
Somni bene
Schwerin, 19053
0049 385207980
Heike Benes
Greece6 sites, 6 recruiting
- Not yet recruiting
Argolida General Hospital
Argos, 212 00
Aikaterini Gamvroula
- Not yet recruiting
Multidisciplinary Mental Health Hospital of Attiki
Athens, 124 62
+302112054278
Christos Tsopelas
- Not yet recruiting
Sismanogleio General Hospital of Attiki
Athens, 151 26
Domna Tsaklakidou
- Not yet recruiting
Attikon General University Hospital
Chaïdári, 124 62
Nikolaos Smyrnis
- Not yet recruiting
University Hospital of Ioannina
Ioannina, 455 00
+302651099667
Petros Petrikis
- Not yet recruiting
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, 564 29
LOUKAS ATHANASIADIS
Puerto Rico3 sites, 3 recruiting
- Recruiting
INSPIRA Clinical Research
San Juan, 00918
7877539515 ext 296
Yvette Cruz-Pagan
- Not yet recruiting
Instituto De Neurologia Dra. Ivonne Fraga
San Juan, 00918
17874035534
Ivonne Fraga Berrios
- Not yet recruiting
Barbara Diaz-Hernandez MD Research, Inc.
San Juan, 00926
787-523-9808
Ileana Fumero-Perez
About this study
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)
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.
- Conditions
- Depressive Disorder, Major
- Being tested
- Brenipatide, Placebo
- Keywords
- Major Depressive Episode, Mood Disorders, Depression, Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major, Mood Disorders, Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrenipatideDrug
Also called LY3537031
Administered SC.
PlaceboDrug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| Brenipatide Dose 1 | Experimental | Brenipatide administered subcutaneous (SC) + standard of care (SoC). Receives: Drug: Brenipatide |
| Brenipatide Dose 2 | Experimental | Brenipatide administered SC + SoC. Receives: Drug: Brenipatide |
| Brenipatide Dose 3 | Experimental | Brenipatide administered SC + SoC. Receives: Drug: Brenipatide |
| Placebo | Placebo comparator | Placebo administered SC + SoC. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months
Secondary outcomes (11)
Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥ 25.0 kg/m^2
Measured: Baseline, up to at least 6 months
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Measured: Baseline, up to at least 6 months
Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score
Measured: Baseline, up to at least 6 months
Change from Baseline in Patient-Reported Outcomes Measurement Information Systems (PROMIS) Short Form
Measured: Baseline, up to at least 6 months
Change from Baseline in Patient Global Impression of Severity (PGI-S)
Measured: Baseline, up to at least 6 months
Change from Baseline in Generalized Anxiety Disorder (GAD) - 7 Total Score
Measured: Baseline, up to at least 6 months
Change from Baseline in Patient Rated Symptom and Disease Severity
Measured: Baseline, up to at least 6 months
Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score
Measured: Baseline, up to at least 6 months
Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m² and on an Atypical Antipsychotic
Measured: Baseline, up to at least 6 months
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Measured: Baseline, up to at least 6 months
Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADA
Measured: Baseline up to at least 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start14 Aug 2026
- Primary completionDec 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775300
- Sponsor's protocol ID
- 27364
- Other IDs
- J2S-MC-GZMI, 2025-522310-24-00, 2025
- Acronym
- RENEW-MDD- 2
- Status last verified
- Oct 2026
- First submitted
- 14 Aug 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07775300
- Acronym / sponsor ID
- RENEW-MDD- 2 / 27364
- Conditions
- Depressive Disorder, Major
- Keywords
- Major Depressive Episode, Mood Disorders, Depression, Depressive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Brenipatide Dose 1 | Experimental | Drug: BrenipatideBrenipatide administered subcutaneous (SC) + standard of care (SoC). |
| Brenipatide Dose 2 | Experimental | Drug: BrenipatideBrenipatide administered SC + SoC. |
| Brenipatide Dose 3 | Experimental | Drug: BrenipatideBrenipatide administered SC + SoC. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered SC + SoC. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Meet the diagnostic criteria for major depressive disorder
- Are on 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
Key exclusion criteria (11 listed)
- Have a lifetime history or current diagnosis of the following:
- Have type 1 diabetes mellitus, or a history of:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrenipatideAlso: LY3537031Administered SC. | Drug | Brenipatide Dose 1, Brenipatide Dose 2, Brenipatide Dose 3 |
| PlaceboAdministered SC. | Drug | Placebo |
Primary outcome
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
11 secondary outcomes
Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥ 25.0 kg/m^2
Time frame: 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
Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score
Time frame: 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
Change from Baseline in Patient Global Impression of Severity (PGI-S)
Time frame: 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
Change from Baseline in Patient Rated Symptom and Disease Severity
Time frame: 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
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
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Time frame: Baseline, 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Lilly TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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) study director
Eli Lilly and Company
170 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brenipatide in people with Depressive Disorder, Major, run by Eli Lilly and Company at 170 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 170 sites in United States, Japan, Spain, Brazil, Poland and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.