Fact CheckerSign in

NCT07412756RecruitingPhase 3

A Study of Brenipatide in Adult Participants With Major Depressive Disorder

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)

Source: ClinicalTrials.gov · Last updated 5 Oct 2026

Brief summary (registry, in English)

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 with a potential post treatment period that combined will last a minimum of 12 months, and the follow up period that will last approximately 2 months.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1000 (estimated)
First submitted
6 Feb 2026
Start date
9 Feb 2026
Primary completion date
29 Feb 2028
Lead sponsor
Eli Lilly and Company
Diseases
Depression
NCT number
NCT07412756
EU CT number
2025-522308-25-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1000
  • From 9 Feb 2026 to the primary completion date, 29 Feb 2028
  • 180 sites in 15 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Other

  • Are actively suicidal or deemed a significant risk for suicide

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (180)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
NeuroCentrix
Coordinator of this site? Confirm its status
CarltonAustraliaRecruiting
Lyell McEwin Hospital
Coordinator of this site? Confirm its status
Elizabeth ValeAustraliaNot yet recruiting
Barwon Health
Coordinator of this site? Confirm its status
GeelongAustraliaRecruiting
Paratus Clinical Research - Melbourne
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
Multidisciplinary Alfred Psychiatry Research Centre
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
Toowoomba Hospital
Coordinator of this site? Confirm its status
ToowoombaAustraliaRecruiting
Westmead Hospital
Coordinator of this site? Confirm its status
WestmeadAustraliaRecruiting
Hospital das Clinicas da UFMG
Coordinator of this site? Confirm its status
Belo HorizonteBrazilNot yet recruiting
Trial Tech
Coordinator of this site? Confirm its status
CuritibaBrazilRecruiting
Centro de Pesquisa Clínica de Marília - CPCLIM
Coordinator of this site? Confirm its status
MaríliaBrazilRecruiting
Clinilive
Coordinator of this site? Confirm its status
MaringáBrazilRecruiting
Hospital Universitário Onofre Lopes
Coordinator of this site? Confirm its status
NatalBrazilRecruiting
Ruschel Medicina e Pesquisa Clínica
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilRecruiting
Facili - Centro Integrado de Psiquiatria
Coordinator of this site? Confirm its status
São Bernardo do CampoBrazilRecruiting
CPCLIN
Coordinator of this site? Confirm its status
São PauloBrazilRecruiting
BR Trials-Ensaios Clinicos e Consultoria
Coordinator of this site? Confirm its status
São PauloBrazilRecruiting
CPQuali Pesquisa Clínica
Coordinator of this site? Confirm its status
São PauloBrazilRecruiting
A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos
Coordinator of this site? Confirm its status
ValinhosBrazilRecruiting
Heritage Medical Research Clinic
Coordinator of this site? Confirm its status
CalgaryCanadaNot yet recruiting
Hamilton Medical Research Group
Coordinator of this site? Confirm its status
HamiltonCanadaRecruiting
Kelowna Health and Memory Centre
Coordinator of this site? Confirm its status
KelownaCanadaNot yet recruiting
Alpha Recherche Clinique - Lévis
Coordinator of this site? Confirm its status
LévisCanadaRecruiting
Genge Partners
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
Dar Clinical Research - Ottawa
Coordinator of this site? Confirm its status
OttawaCanadaRecruiting
Alpha Recherche Clinique
Coordinator of this site? Confirm its status
QuébecCanadaRecruiting
Centre de Recherche Saint-Louis inc.
Coordinator of this site? Confirm its status
QuébecCanadaNot yet recruiting
Richmond Clinical Trials
Coordinator of this site? Confirm its status
RichmondCanadaRecruiting
Bluewater Clinical Research Group Inc.
Coordinator of this site? Confirm its status
SarniaCanadaRecruiting
Diex Recherche Sherbrooke
Coordinator of this site? Confirm its status
SherbrookeCanadaSuspended
Centre for Neurology Studies
Coordinator of this site? Confirm its status
SurreyCanadaNot yet recruiting
Maple Leaf Research
Coordinator of this site? Confirm its status
TorontoCanadaSuspended
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
Beijing Huilongguan Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
The Second People's Hospital of Hunan Province
Coordinator of this site? Confirm its status
ChangshaChinaRecruiting
Chaohu Hospital of Anhui Medical University
Coordinator of this site? Confirm its status
ChaohuChinaNot yet recruiting
The Fourth People's Hospital of Chengdu
Coordinator of this site? Confirm its status
ChengduChinaRecruiting
Guangzhou Brain Hospital
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
Peking University Sixth Hospital
Coordinator of this site? Confirm its status
Haidian DistrictChinaRecruiting
Hefei No.4 People's Hospital
Coordinator of this site? Confirm its status
HefeiChinaRecruiting
3rd People's Hospital of Huzhou
Coordinator of this site? Confirm its status
HuzhouChinaRecruiting
Shandong Daizhuang Hospital
Coordinator of this site? Confirm its status
JiningChinaRecruiting
The First Affiliated Hospital of NanChang University
Coordinator of this site? Confirm its status
NanchangChinaRecruiting
The Affilicated Kangning Hospital of Ningbo University
Coordinator of this site? Confirm its status
NingboChinaRecruiting
Shanghai Mental Health Center
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
The First Hospital of Hebei Medical University
Coordinator of this site? Confirm its status
ShijiazhuangChinaRecruiting
Suzhou Guangji Hospital
Coordinator of this site? Confirm its status
SuzhouChinaRecruiting
Tianjin Anding Hospital
Coordinator of this site? Confirm its status
TianjinChinaRecruiting
Renmin Hospital of Wuhan University
Coordinator of this site? Confirm its status
WuhanChinaRecruiting
Wuxi Mental Health Center
Coordinator of this site? Confirm its status
WuxiChinaRecruiting
Xi'an Mental Health Center
Coordinator of this site? Confirm its status
Xi’anChinaRecruiting
Xianyang Hospital of Yan'an University
Coordinator of this site? Confirm its status
XianyangChinaRecruiting
Zhenjiang mental health center
Coordinator of this site? Confirm its status
ZhenjiangChinaNot yet recruiting
Zhumadian Psychiatric Hospital
Coordinator of this site? Confirm its status
ZhumadianChinaRecruiting
Universitätsklinikum Aachen
Coordinator of this site? Confirm its status
AachenGermanyRecruiting
FutureMeds Berlin
Coordinator of this site? Confirm its status
BerlinGermanyRecruiting
Neurozentrum Bielefeld
Coordinator of this site? Confirm its status
BielefeldGermanyRecruiting
Pharmakologisches Studienzentrum Chemnitz
Coordinator of this site? Confirm its status
ChemnitzGermanyRecruiting
Universitätsmedizin Johannes Gutenberg Universität Mainz
Coordinator of this site? Confirm its status
MainzGermanyNot yet recruiting
ISPG - Institut für Studien zur Psychischen Gesundheit
Coordinator of this site? Confirm its status
MannheimGermanyRecruiting
Somni bene
Coordinator of this site? Confirm its status
SchwerinGermanyRecruiting
ZNS Siegen
Coordinator of this site? Confirm its status
SiegenGermanyRecruiting
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Institucion Hosp Hestia Palau
Coordinator of this site? Confirm its status
BarcelonaSpainNot yet recruiting
Parc de Salut Mar - Hospital del Mar
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitario Infanta Leonor
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Centro de Atención Integral La Corredoria
Coordinator of this site? Confirm its status
OviedoSpainNot yet recruiting
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Coordinator of this site? Confirm its status
SalamancaSpainRecruiting
Complejo Asistencial de Zamora
Coordinator of this site? Confirm its status
ZamoraSpainRecruiting
Edinburgh Royal Infirmary
Coordinator of this site? Confirm its status
EdinburghUnited KingdomRecruiting
Devon Partnership Trust
Coordinator of this site? Confirm its status
ExeterUnited KingdomRecruiting
Queen Elizabeth University Hospital
Coordinator of this site? Confirm its status
GlasgowUnited KingdomRecruiting
Clerkenwell Health - London - Welbeck Street
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
The Maudsley Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Queen's Medical Centre, Nottingham University Hospitals
Coordinator of this site? Confirm its status
NottinghamUnited KingdomRecruiting
Warneford Hospital
Coordinator of this site? Confirm its status
OxfordUnited KingdomRecruiting
St Bartholomew's Medical Centre
Coordinator of this site? Confirm its status
OxfordUnited KingdomRecruiting
Atlantic Medical
Coordinator of this site? Confirm its status
PenzanceUnited KingdomRecruiting
Woodstock Bower Surgery
Coordinator of this site? Confirm its status
RotherhamUnited KingdomRecruiting
Argolida General Hospital
Coordinator of this site? Confirm its status
ArgosGreeceRecruiting
Aiginiteio University Hospital
Coordinator of this site? Confirm its status
AthensGreeceRecruiting
Multidisciplinary Mental Health Hospital of Attiki
Coordinator of this site? Confirm its status
AthensGreeceRecruiting
Attikon General University Hospital
Coordinator of this site? Confirm its status
ChaïdáriGreeceRecruiting
Multidisciplinary Mental Health Hospital of Thessaloniki
Coordinator of this site? Confirm its status
StavroupoliGreeceRecruiting
Papageorgiou General Hospital of Thessaloniki
Coordinator of this site? Confirm its status
ThessalonikiGreeceRecruiting
General Hospital of Tripoli Panarkadiko Evangelistria
Coordinator of this site? Confirm its status
TripoliGreeceRecruiting
Abe Clinic - Arakawa
Coordinator of this site? Confirm its status
Arakawa CityJapanRecruiting
Uematsu Mental Clinic
Coordinator of this site? Confirm its status
ChikugoJapanRecruiting
Jimbocho Mental Clinic
Coordinator of this site? Confirm its status
Chiyoda CityJapanRecruiting
Kokorono Clinic Hirao
Coordinator of this site? Confirm its status
FukuokaJapanRecruiting
Fukuoka University Hospital
Coordinator of this site? Confirm its status
FukuokaJapanRecruiting
Horikoshi Mental Somatic Clinic
Coordinator of this site? Confirm its status
FukushimaJapanRecruiting
University of the Ryukyus Hospital
Coordinator of this site? Confirm its status
GinowanJapanRecruiting
Fujimidai Hospital
Coordinator of this site? Confirm its status
HiratsukaJapanRecruiting
Rainbow and Sea Hospital
Coordinator of this site? Confirm its status
KaratsuJapanRecruiting
Kishiro Mental Clinic
Coordinator of this site? Confirm its status
KawasakiJapanRecruiting
Monzen-nakacho Mental Clinic
Coordinator of this site? Confirm its status
Kōtō CityJapanRecruiting
Suizenji Life Clinic
Coordinator of this site? Confirm its status
KumamotoJapanRecruiting
Yuge Hospital
Coordinator of this site? Confirm its status
KumamotoJapanRecruiting
Kure Medical Center
Coordinator of this site? Confirm its status
KureJapanRecruiting
Hirota Clinic
Coordinator of this site? Confirm its status
KurumeJapanRecruiting
Senzoku Psychosomatic Medicine Clinic
Coordinator of this site? Confirm its status
Meguro-kuJapanRecruiting
Arata Clinic
Coordinator of this site? Confirm its status
NagasakiJapanRecruiting
Yutaka Clinic
Coordinator of this site? Confirm its status
SagamiharaJapanRecruiting
Sangenjaya Shinkeika Shinryonaika Clinic
Coordinator of this site? Confirm its status
Setagaya CityJapanRecruiting
Maynds Tower Mental Clinic
Coordinator of this site? Confirm its status
Shibuya-kuJapanRecruiting
Nanko Kokorono Clinic
Coordinator of this site? Confirm its status
ShirakawaJapanRecruiting
Sakurazaka Clinic SophyAnce
Coordinator of this site? Confirm its status
TokyoJapanRecruiting
Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi
Coordinator of this site? Confirm its status
TokyoJapanRecruiting
Yamagata Sakuracho Hospital
Coordinator of this site? Confirm its status
YamagataJapanRecruiting
Miki Mental Clinic
Coordinator of this site? Confirm its status
YokohamaJapanRecruiting
Shioiri Mental Clinic
Coordinator of this site? Confirm its status
YokosukaJapanRecruiting
Korea University Ansan Hospital
Coordinator of this site? Confirm its status
Ansan-siSouth KoreaRecruiting
Chonnam National University Hospital
Coordinator of this site? Confirm its status
GwangjuSouth KoreaRecruiting
Jeju National University Hospital
Coordinator of this site? Confirm its status
Jeju CitySouth KoreaRecruiting
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Seoul National University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Konkuk University Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Scientia Investigacion Clinica S.C.
Coordinator of this site? Confirm its status
Chihuahua CityMexicoNot yet recruiting
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Coordinator of this site? Confirm its status
GuadalajaraMexicoNot yet recruiting
B&B Investigaciones Medicas S.C.
Coordinator of this site? Confirm its status
MazatlánMexicoNot yet recruiting
Medical Care and Research Sa de Cv
Coordinator of this site? Confirm its status
MéridaMexicoNot yet recruiting
Ketamine Clinic México
Coordinator of this site? Confirm its status
Mexico CityMexicoNot yet recruiting
GabiPros
Coordinator of this site? Confirm its status
Mexico CityMexicoNot yet recruiting
Centro de Investigacion Clinica Chapultepec
Coordinator of this site? Confirm its status
MoreliaMexicoNot yet recruiting
Arké SMO S.A de C.V
Coordinator of this site? Confirm its status
VeracruzMexicoNot yet recruiting
Podlaskie Centrum Psychogeriatrii
Coordinator of this site? Confirm its status
BialystokPolandRecruiting
MentalMEDIC
Coordinator of this site? Confirm its status
Bielsko-BialaPolandNot yet recruiting
Centrum Badan Klinicznych PI-House sp. z o.o.
Coordinator of this site? Confirm its status
GdanskPolandNot yet recruiting
Diamond Clinic
Coordinator of this site? Confirm its status
KrakowPolandRecruiting
NZOZ Psychiatrycznej Mentis
Coordinator of this site? Confirm its status
LesznoPolandNot yet recruiting
Private Practice - Dr. Małgorzata Wojtanowska-Bogacka
Coordinator of this site? Confirm its status
PoznanPolandRecruiting
Centrum Medyczne Euromedis
Coordinator of this site? Confirm its status
SzczecinPolandNot yet recruiting
Centrum Medyczne Ginemedica
Coordinator of this site? Confirm its status
WroclawPolandRecruiting
ClinHouse Centrum Medyczne
Coordinator of this site? Confirm its status
ZabrzePolandNot yet recruiting
SCB Research Center
Coordinator of this site? Confirm its status
BayamónPuerto RicoRecruiting
Keelung Chang Gung Memorial Hospital
Coordinator of this site? Confirm its status
KeelungTaiwanRecruiting
Chung Shan Medical University Hospital
Coordinator of this site? Confirm its status
TaichungTaiwanRecruiting
National Cheng Kung University Hospital
Coordinator of this site? Confirm its status
TainanTaiwanRecruiting
Taipei Medical University Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
Cheng Hsin General Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
National Taiwan University Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
Taipei Veterans General Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
Chang Gung Medical Foundation-Linkou Branch
Coordinator of this site? Confirm its status
TaoyuanTaiwanRecruiting
Pharmasite Research, Inc.
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
Northwest Clinical Research Center
Coordinator of this site? Confirm its status
BellevueUnited StatesRecruiting
Adams Clinical Boston
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Alpine Research Organization
Coordinator of this site? Confirm its status
ClintonUnited StatesRecruiting
CenExel iResearch, LLC
Coordinator of this site? Confirm its status
DecaturUnited StatesRecruiting
Adams Clinical Dallas
Coordinator of this site? Confirm its status
DeSotoUnited StatesRecruiting
Re:Cognition Health
Coordinator of this site? Confirm its status
FairfaxUnited StatesRecruiting
Re:Cognition Health - Fort Worth
Coordinator of this site? Confirm its status
Fort WorthUnited StatesRecruiting
K2 Medical Research - Foxborough
Coordinator of this site? Confirm its status
FoxboroughUnited StatesRecruiting
Encore Medical Research
Coordinator of this site? Confirm its status
HollywoodUnited StatesRecruiting
Indiana University Health Neuroscience Center
Coordinator of this site? Confirm its status
IndianapolisUnited StatesRecruiting
Vector Clinical Trials
Coordinator of this site? Confirm its status
Las VegasUnited StatesRecruiting
K2 Medical Research - Maitland
Coordinator of this site? Confirm its status
MaitlandUnited StatesRecruiting
Life Medical Research Group Corp
Coordinator of this site? Confirm its status
Miami GardensUnited StatesRecruiting
Floridian Clinical Research, LLC
Coordinator of this site? Confirm its status
Miami LakesUnited StatesRecruiting
Accellacare - Moorpark
Coordinator of this site? Confirm its status
MoorparkUnited StatesRecruiting
CLA Research
Coordinator of this site? Confirm its status
NaplesUnited StatesRecruiting
Yale University School Of Medicine
Coordinator of this site? Confirm its status
New HavenUnited StatesRecruiting
Adams Clinical Harlem
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
ATP Clinical Research
Coordinator of this site? Confirm its status
OrangeUnited StatesRecruiting
Optimal Research Sites
Coordinator of this site? Confirm its status
Orange CityUnited StatesRecruiting
Charter Research - Orlando
Coordinator of this site? Confirm its status
OrlandoUnited StatesRecruiting
Penn Medicine: University of Pennsylvania Health System
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Summit Headlands
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting
Consano Clinical Research, LLC
Coordinator of this site? Confirm its status
Shavano ParkUnited StatesRecruiting
Circle Clinical Research
Coordinator of this site? Confirm its status
Sioux FallsUnited StatesRecruiting
Arch Clinical Trials
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
K2 Medical Research - Tampa
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Coordinator of this site? Confirm its status
TroyUnited StatesRecruiting
Cedar Valley Medical Specialists
Coordinator of this site? Confirm its status
WaterlooUnited StatesRecruiting
Adams Clinical Watertown
Coordinator of this site? Confirm its status
WatertownUnited StatesRecruiting
Suburban Research Associates
Coordinator of this site? Confirm its status
West ChesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.