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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: 2026-07-20
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 (180)
Accellacare - MoorparkRecruiting
Moorpark, California, United States
ATP Clinical ResearchRecruiting
Orange, California, United States
Yale University School of MedicineRecruiting
New Haven, Connecticut, United States
Encore Medical ResearchRecruiting
Hollywood, Florida, United States
K2 Medical Research - MaitlandRecruiting
Maitland, Florida, United States
Life Medical Research Group CorpRecruiting
Miami Gardens, Florida, United States
Floridian Clinical Research, LLCRecruiting
Miami Lakes, Florida, United States
CLA ResearchRecruiting
Naples, Florida, United States
Optimal Research SitesRecruiting
Orange City, Florida, United States
Charter Research - OrlandoRecruiting
Orlando, Florida, United States
K2 Medical Research - TampaRecruiting
Tampa, Florida, United States
CenExel iResearch, LLCRecruiting
Decatur, Georgia, United States
Indiana University Health Neuroscience CenterRecruiting
Indianapolis, Indiana, United States
Cedar Valley Medical SpecialistsRecruiting
Waterloo, Iowa, United States
Pharmasite Research, Inc.Recruiting
Baltimore, Maryland, United States
Adams Clinical BostonRecruiting
Boston, Massachusetts, United States
K2 Medical Research - FoxboroughRecruiting
Foxborough, Massachusetts, United States
Adams Clinical WatertownRecruiting
Watertown, Massachusetts, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionRecruiting
Troy, Michigan, United States
Arch Clinical TrialsRecruiting
St Louis, Missouri, United States
Vector Clinical TrialsRecruiting
Las Vegas, Nevada, United States
Adams Clinical HarlemRecruiting
New York, New York, United States
Summit HeadlandsRecruiting
Portland, Oregon, United States
Suburban Research AssociatesRecruiting
Media, Pennsylvania, United States
Penn Medicine: University of Pennsylvania Health SystemRecruiting
Philadelphia, Pennsylvania, United States
Circle Clinical ResearchNot Yet Recruiting
Sioux Falls, South Dakota, United States
Adams Clinical DallasRecruiting
DeSoto, Texas, United States
Re:Cognition Health - Fort WorthRecruiting
Fort Worth, Texas, United States
Consano Clinical Research, LLCRecruiting
Shavano Park, Texas, United States
Alpine Research OrganizationRecruiting
Clinton, Utah, United States
Re:Cognition HealthRecruiting
Fairfax, Virginia, United States
Northwest Clinical Research CenterRecruiting
Bellevue, Washington, United States
NeuroCentrixNot Yet Recruiting
Carlton, Australia
Lyell McEwin HospitalNot Yet Recruiting
Elizabeth Vale, Australia
Barwon HealthRecruiting
Geelong, Australia
Multidisciplinary Alfred Psychiatry Research CentreRecruiting
Melbourne, Australia
Paratus Clinical Research - MelbourneRecruiting
Melbourne, Australia
Toowoomba HospitalRecruiting
Toowoomba, Australia
Westmead HospitalRecruiting
Westmead, Australia
Hospital das Clínicas da UFMGNot Yet Recruiting
Belo Horizonte, Brazil
Trial TechRecruiting
Curitiba, Brazil
CliniliveNot Yet Recruiting
Maringá, Brazil
Centro de Pesquisa Clínica de Marília - CPCLIMRecruiting
Marília, Brazil
Hospital Universitário Onofre LopesRecruiting
Natal, Brazil
Ruschel Medicina e Pesquisa ClínicaRecruiting
Rio de Janeiro, Brazil
Facili Centro Integrado de PsiquiatriaRecruiting
São Bernardo do Campo, Brazil
CPQuali Pesquisa ClínicaRecruiting
São Paulo, Brazil
CPCLINNot Yet Recruiting
São Paulo, Brazil
BR Trials - Ensaios Clinicos e ConsultoriaRecruiting
São Paulo, Brazil
A2Z Clinical Centro Avançado De Pesquisa Clínica - ValinhosNot Yet Recruiting
Valinhos, Brazil
Heritage Medical Research ClinicNot Yet Recruiting
Calgary, Canada
Premier Clinical Trial NetworkNot Yet Recruiting
Hamilton, Canada
Kelowna Health and Memory CentreNot Yet Recruiting
Kelowna, Canada
Alpha Recherche Clinique - LévisNot Yet Recruiting
Lévis, Canada
Genge PartnersNot Yet Recruiting
Montreal, Canada
Dar Clinical Research - OttawaRecruiting
Ottawa, Canada
Centre de Recherche Saint-Louis inc.Not Yet Recruiting
Québec, Canada
Alpha Recherche CliniqueNot Yet Recruiting
Québec, Canada
ALPHA Recherche CliniqueNot Yet Recruiting
Québec, Canada
Richmond Clinical TrialsRecruiting
Richmond, Canada
Bluewater Clinical Research Group Inc.Not Yet Recruiting
Sarnia, Canada
Diex Recherche SherbrookeSuspended
Sherbrooke, Canada
Centre for Neurology StudiesNot Yet Recruiting
Surrey, Canada
Maple Leaf ResearchSuspended
Toronto, Canada
Beijing Anding Hospital - Affiliated Capital University of Medical ScienceRecruiting
Beijing, China
Beijing HuiLongGuan HospitalRecruiting
Beijing, China
The Second People's Hospital of Hunan ProvinceRecruiting
Changsha, China
The Fourth People's Hospital of ChengduRecruiting
Chengdu, China
Guangzhou Brain HospitalRecruiting
Guangzhou, China
Peking University Sixth HospitalRecruiting
Haidian District, China
Hefei No.4 People's HospitalRecruiting
Hefei, China
3rd People's Hospital of HuzhouRecruiting
Huzhou, China
Shandong Daizhuang HospitalRecruiting
Jining, China
The First Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, China
The Affilicated Kangning Hospital of Ningbo UniversityRecruiting
Ningbo, China
Shanghai Mental Health CenterRecruiting
Shanghai, China
The First Hospital of Hebei Medical UniversityRecruiting
Shijiazhuang, China
Suzhou Guangji HospitalRecruiting
Suzhou, China
Tianjin Anding HospitalRecruiting
Tianjin, China
Renmin Hospital of Wuhan UniversityRecruiting
Wuhan, China
Wuxi Mental Health CenterRecruiting
Wuxi, China
Xi An Mental Health CenterRecruiting
Xi'an, China
Xianyang Hospital of Yan'an UniversityRecruiting
Xianyang, China
Zhumadian Psychiatric HospitalRecruiting
Zhumadian, China
Universitätsklinikum AachenNot Yet Recruiting
Aachen, Germany
FutureMeds GmbHRecruiting
Berlin, Germany
Neurozentrum BielefeldNot Yet Recruiting
Bielefeld, Germany
Pharmakologisches Studienzentrum ChemnitzNot Yet Recruiting
Chemnitz, Germany
Universitätsmedizin Johannes Gutenberg Universität MainzNot Yet Recruiting
Mainz, Germany
ISPG - Institut für Studien zur Psychischen GesundheitRecruiting
Mannheim, Germany
Somni beneRecruiting
Schwerin, Germany
ZNS SiegenNot Yet Recruiting
Siegen, Germany
Argolida General HospitalRecruiting
Argos, Greece
Aiginiteio University HospitalNot Yet Recruiting
Athens, Greece
Multidisciplinary Mental Health Hospital of AttikiNot Yet Recruiting
Athens, Greece
Attikon General University HospitalRecruiting
Chaïdári, Greece
Multidisciplinary Mental Health Hospital of ThessalonikiNot Yet Recruiting
Stavroupoli, Greece
Papageorgiou General Hospital of ThessalonikiNot Yet Recruiting
Thessaloniki, Greece
General Hospital of Tripoli Panarkadiko EvangelistriaRecruiting
Tripoli, Greece
Abe Clinic - ArakawaRecruiting
Arakawa City, Japan
Uematsu Mental ClinicRecruiting
Chikugo, Japan
Jimbocho Mental ClinicRecruiting
Chiyoda City, Japan
Fukuoka University HospitalRecruiting
Fukuoka, Japan
Kokorono Clinic HiraoRecruiting
Fukuoka, Japan
Horikoshi Mental Somatic ClinicRecruiting
Fukushima, Japan
University of the Ryukyus HospitalRecruiting
Ginowan, Japan
Fujimidai HospitalRecruiting
Hiratsuka, Japan
Rainbow and Sea HospitalRecruiting
Karatsu, Japan
Kishiro Mental ClinicRecruiting
Kawasaki, Japan
Monzen-nakacho Mental ClinicRecruiting
Kōtō City, Japan
Yuge HospitalRecruiting
Kumamoto, Japan
Suizenji Life ClinicRecruiting
Kumamoto, Japan
Kure Medical CenterRecruiting
Kure, Japan
Hirota ClinicRecruiting
Kurume, Japan
Senzoku Psychosomatic Medicine ClinicRecruiting
Meguro-ku, Japan
Arata ClinicRecruiting
Nagasaki, Japan
Yutaka ClinicRecruiting
Sagamihara, Japan
Sangenjaya Shinkeika Shinryonaika ClinicRecruiting
Setagaya City, Japan
Maynds Tower Mental ClinicRecruiting
Shibuya-ku, Japan
Nanko Kokorono ClinicRecruiting
Shirakawa, Japan
Sakurazaka Clinic SophyAnceRecruiting
Tokyo, Japan
Himorogi Psychiatric Institute - Tokyo - IchigayatamachiRecruiting
Tokyo, Japan
Yamagata Sakuracho HospitalRecruiting
Yamagata, Japan
Miki Mental ClinicRecruiting
Yokohama, Japan
Shioiri Mental ClinicRecruiting
Yokosuka, Japan
Scientia Investigacion Clinica S.C.Not Yet Recruiting
Chihuahua City, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.Not Yet Recruiting
Guadalajara, Mexico
B&B Investigaciones Medicas S.C.Not Yet Recruiting
Mazatlán, Mexico
Ketamine Clinic MéxicoNot Yet Recruiting
Mexico City, Mexico
GabiProsNot Yet Recruiting
Mexico City, Mexico
Medical Care and Research SA de CVNot Yet Recruiting
Mérida, Mexico
Centro de Investigacion Clinica ChapultepecNot Yet Recruiting
Morelia, Mexico
Arké SMO S.A de C.VNot Yet Recruiting
Veracruz, Mexico
Podlaskie Centrum PsychogeriatriiNot Yet Recruiting
Bialystok, Poland
MentalMEDICNot Yet Recruiting
Bielsko-Biala, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.Not Yet Recruiting
Gdansk, Poland
Diamond ClinicNot Yet Recruiting
Krakow, Poland
NZOZ Psychiatrycznej MentisNot Yet Recruiting
Leszno, Poland
Private Practice - Dr. Małgorzata Wojtanowska-BogackaNot Yet Recruiting
Poznan, Poland
Centrum Medyczne EuromedisNot Yet Recruiting
Szczecin, Poland
Medical Concierge Centrum MedyczneNot Yet Recruiting
Warsaw, Poland
Centrum Medyczne GinemedicaNot Yet Recruiting
Wroclaw, Poland
Clinhouse Centrum MedyczneNot Yet Recruiting
Zabrze, Poland
SCB Research CenterRecruiting
Bayamón, Puerto Rico
Korea University Ansan HospitalRecruiting
Ansan-si, South Korea
Chonnam National University HospitalRecruiting
Gwangju, South Korea
Jeju National University HospitalRecruiting
Jeju City, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Konkuk University Medical CenterRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
The Catholic Univ. of Korea Seoul St. Mary's HospitalRecruiting
Seoul, South Korea
Parc de Salut Mar - Hospital del MarRecruiting
Barcelona, Spain
Institucion Hosp Hestia PalauNot Yet Recruiting
Barcelona, Spain
Hospital Universitari Vall d'HebronNot Yet Recruiting
Barcelona, Spain
Hospital Clínic de BarcelonaRecruiting
Barcelona, Spain
Hospital de la Santa Creu i Sant PauRecruiting
Barcelona, Spain
Hospital Universitario Infanta LeonorRecruiting
Madrid, Spain
Centro de Atención Integral La CorredoriaNot Yet Recruiting
Oviedo, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de SalamancaRecruiting
Salamanca, Spain
Complejo Asistencial de ZamoraRecruiting
Zamora, Spain
Keelung Chang Gung Memorial HospitalRecruiting
Keelung, Taiwan
Chung Shan Medical University HospitalRecruiting
Taichung, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Medical University HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Cheng Hsin General HospitalNot Yet Recruiting
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou BranchRecruiting
Taoyuan, Taiwan
Edinburgh Royal InfirmaryNot Yet Recruiting
Edinburgh, United Kingdom
Devon Partnership TrustRecruiting
Exeter, United Kingdom
Queen Elizabeth University HospitalRecruiting
Glasgow, United Kingdom
The Maudsley HospitalRecruiting
London, United Kingdom
Clerkenwell Health - London - Welbeck StreetRecruiting
London, United Kingdom
Queen's Medical Centre, Nottingham University HospitalsNot Yet Recruiting
Nottingham, United Kingdom
Warneford HospitalRecruiting
Oxford, United Kingdom
St Bartholomew's Medical CentreRecruiting
Oxford, United Kingdom
Atlantic MedicalRecruiting
Penzance, United Kingdom
Woodstock Bower SurgeryRecruiting
Rotherham, United Kingdom
A Study of Brenipatide in Adult Participants With Major Depressive Disorder · TrialPath