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A Study of Brenipatide in Adult Participants With Major Depressive Disorder

NCT07412756 · Eli Lilly and Company
In plain English

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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 1)
About this study
This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms. The trial is divided into three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.
Eligibility criteria
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 design
Enrollment target: 1000 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-02-09
Estimated completion: 2028-02
Last updated: 2026-03-23
Interventions
Drug: BrenipatideDrug: Placebo
Primary outcomes
  • 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) (From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 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
All locations (186)
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Orange, California, United States
Yale University School of MedicineNot Yet Recruiting
New Haven, Connecticut, United States
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Life Medical Research Group CorpRecruiting
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Naples, Florida, United States
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DeSoto, Texas, United States
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Shavano Park, Texas, United States
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Clinton, Utah, United States
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Fairfax, Virginia, United States
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Bellevue, Washington, United States
Mater Misericordiae LimitedNot Yet Recruiting
Brisbane, Australia
NeuroCentrixNot Yet Recruiting
Carlton, Australia
Lyell McEwin HospitalNot Yet Recruiting
Elizabeth Vale, Australia
Barwon HealthNot Yet Recruiting
Geelong, Australia
Multidisciplinary Alfred Psychiatry Research CentreNot Yet Recruiting
Melbourne, Australia
Paratus Clinical Research - MelbourneNot Yet Recruiting
Melbourne, Australia
Mildura Base HospitalNot Yet Recruiting
Mildura, Australia
Toowoomba HospitalNot Yet Recruiting
Toowoomba, Australia
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Waitara, Australia
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Westmead, Australia
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Trial TechNot Yet Recruiting
Curitiba, Brazil
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Maringá, Brazil
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Ruschel Medicina e Pesquisa ClínicaNot Yet Recruiting
Rio de Janeiro, Brazil
Facili Centro Integrado de PsiquiatriaNot Yet Recruiting
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Heritage Medical Research ClinicNot Yet Recruiting
Calgary, Canada
Winterberry Research Inc.Not Yet Recruiting
Hamilton, Canada
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Alpha Recherche Clinique - LévisNot Yet Recruiting
Lévis, Canada
Genge PartnersNot Yet Recruiting
Montreal, Canada
Dar Clinical Research - OttawaNot Yet Recruiting
Ottawa, Canada
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Québec, Canada
Alpha Recherche CliniqueNot Yet Recruiting
Québec, Canada
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Québec, Canada
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Richmond, Canada
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Sarnia, Canada
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Surrey, Canada
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Hefei, China
3rd People's Hospital of HuzhouNot Yet Recruiting
Huzhou, China
Shandong Daizhuang HospitalNot Yet Recruiting
Jining, China
The First Affiliated Hospital of Nanchang UniversityNot Yet Recruiting
Nanchang, China
The Affilicated Kangning Hospital of Ningbo UniversityNot Yet Recruiting
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Shanghai Mental Health CenterNot Yet Recruiting
Shanghai, China
The First Hospital of Hebei Medical UniversityNot Yet Recruiting
Shijiazhuang, China
Suzhou Guangji HospitalNot Yet Recruiting
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Tianjin Anding HospitalNot Yet Recruiting
Tianjin, China
Renmin Hospital of Wuhan UniversityNot Yet Recruiting
Wuhan, China
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Wuxi, China
Xi An Mental Health CenterNot Yet Recruiting
Xi'an, China
Xianyang Hospital of Yan'an UniversityNot Yet Recruiting
Xianyang, China
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Zhumadian, China
Universitätsklinikum AachenNot Yet Recruiting
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FutureMeds GmbHNot Yet Recruiting
Berlin, Germany
Neurozentrum BielefeldNot Yet Recruiting
Bielefeld, Germany
Pharmakologisches Studienzentrum ChemnitzNot Yet Recruiting
Chemnitz, Germany
Universitätsmedizin Johannes Gutenberg Universität MainzNot Yet Recruiting
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ISPG - Institut für Studien zur Psychischen GesundheitNot Yet Recruiting
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Somni beneNot Yet Recruiting
Schwerin, Germany
ZNS SiegenNot Yet Recruiting
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Argolida General HospitalNot Yet Recruiting
Argos, Greece
Aiginiteio University HospitalNot Yet Recruiting
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Multidisciplinary Mental Health Hospital of AttikiNot Yet Recruiting
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Attikon General University HospitalNot Yet Recruiting
Chaïdári, Greece
Multidisciplinary Mental Health Hospital of ThessalonikiNot Yet Recruiting
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Papageorgiou General Hospital of ThessalonikiNot Yet Recruiting
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General Hospital of Tripoli Panarkadiko EvangelistriaNot Yet Recruiting
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Abe Clinic - ArakawaNot Yet Recruiting
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Uematsu Mental ClinicNot Yet Recruiting
Chikugo, Japan
Jimbocho Mental ClinicNot Yet Recruiting
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Fukuoka University HospitalNot Yet Recruiting
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Horikoshi Mental Somatic ClinicNot Yet Recruiting
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Fujimidai HospitalNot Yet Recruiting
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Konkuk University Medical CenterNot Yet Recruiting
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Asan Medical CenterNot Yet Recruiting
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Hospital Universitario de Araba (HUA)- Hospital TxagorritxuNot Yet Recruiting
Vitoria-Gasteiz, Spain
Complejo Asistencial de ZamoraNot Yet Recruiting
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Keelung Chang Gung Memorial HospitalNot Yet Recruiting
Keelung, Taiwan
Chung Shan Medical University HospitalNot Yet Recruiting
Taichung, Taiwan
National Cheng Kung University HospitalNot Yet Recruiting
Tainan, Taiwan
National Taiwan University HospitalNot Yet Recruiting
Taipei, Taiwan
Taipei Medical University HospitalNot Yet Recruiting
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Taipei Veterans General HospitalNot Yet Recruiting
Taipei, Taiwan
Cheng Hsin General HospitalNot Yet Recruiting
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou BranchNot Yet Recruiting
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Edinburgh Royal InfirmaryNot Yet Recruiting
Edinburgh, United Kingdom
Devon Partnership TrustNot Yet Recruiting
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Queen Elizabeth University HospitalNot Yet Recruiting
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London, United Kingdom
Clerkenwell Health - London - Welbeck StreetNot Yet Recruiting
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Nottingham, United Kingdom
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Oxford, United Kingdom
St Bartholomew's Medical CentreNot Yet Recruiting
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Atlantic MedicalNot Yet Recruiting
Penzance, United Kingdom
Woodstock Bower SurgeryNot Yet Recruiting
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A Study of Brenipatide in Adult Participants With Major Depressive Disorder · TrialPath