A Study of Brenipatide in Adult Participants With Major Depressive Disorder | NCT07412756 | Trialant
RecruitingInterventionalPhase 3Updated Aug 6, 2026
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)
ClinicalTrials.gov ID
NCT07412756
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Overall Status
Recruiting
Study Type
Interventional
Phase
Phase 3
Enrollment
1,000Estimated
Last Update Posted
Aug 6, 2026Actual
Start Date
Feb 9, 2026Actual
Primary Completion Date
Feb 2028Estimated
Completion Date
Feb 2028Estimated
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)
Brief 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.
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.
Depressive Disorder, Major
Brenipatide
Placebo
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orContact
LillyTrials@Lilly.com1-317-615-4559
Physicians interested in becoming principal investigators please contactContact
clinical_inquiry_hub@lilly.com
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Accellacare - MoorparkRecruiting
Moorpark, California 93021, United States
-Contact
747-998-0394
Arjun ReyesPrincipal Investigator
ATP Clinical ResearchRecruiting
Orange, California 92866, United States
Yale University School of MedicineRecruiting
New Haven, Connecticut 06519, United States
Encore Medical ResearchRecruiting
Hollywood, Florida 33024, United States
K2 Medical Research - MaitlandRecruiting
Maitland, Florida 32751, United States
Life Medical Research Group CorpRecruiting
Miami Gardens, Florida 33014, United States
Floridian Clinical Research, LLCRecruiting
Miami Lakes, Florida 33016-1518, United States
CLA ResearchRecruiting
Naples, Florida 34116, United States
Optimal Research SitesRecruiting
Orange City, Florida 32763, United States
Charter Research - OrlandoRecruiting
Orlando, Florida 32803, United States
K2 Medical Research - TampaRecruiting
Tampa, Florida 33634, United States
CenExel iResearch, LLCRecruiting
Decatur, Georgia 30030, United States
Indiana University Health Neuroscience CenterRecruiting
Indianapolis, Indiana 46202, United States
Cedar Valley Medical SpecialistsRecruiting
Waterloo, Iowa 50701, United States
Pharmasite Research, Inc.Recruiting
Baltimore, Maryland 21208, United States
Adams Clinical BostonRecruiting
Boston, Massachusetts 02116, United States
K2 Medical Research - FoxboroughRecruiting
Foxborough, Massachusetts 02035, United States
Adams Clinical WatertownRecruiting
Watertown, Massachusetts 02472, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionRecruiting
Troy, Michigan 48098, United States
Arch Clinical TrialsRecruiting
St Louis, Missouri 63141, United States
Vector Clinical TrialsRecruiting
Las Vegas, Nevada 89128, United States
Adams Clinical HarlemRecruiting
New York, New York 10029, United States
Summit HeadlandsRecruiting
Portland, Oregon 97210, United States
Suburban Research AssociatesRecruiting
Media, Pennsylvania 19063, United States
Penn Medicine: University of Pennsylvania Health SystemRecruiting
Philadelphia, Pennsylvania 19104, United States
Circle Clinical ResearchNot yet recruiting
Sioux Falls, South Dakota 57104, United States
Adams Clinical DallasRecruiting
DeSoto, Texas 75115, United States
Re:Cognition Health - Fort WorthRecruiting
Fort Worth, Texas 76104, United States
Consano Clinical Research, LLCRecruiting
Shavano Park, Texas 78231, United States
Alpine Research OrganizationRecruiting
Clinton, Utah 84015, United States
Re:Cognition HealthRecruiting
Fairfax, Virginia 22031, United States
Northwest Clinical Research CenterRecruiting
Bellevue, Washington 98007, United States
NeuroCentrixRecruiting
Carlton, 3053, Australia
Lyell McEwin HospitalNot yet recruiting
Elizabeth Vale, 5112, Australia
Barwon HealthRecruiting
Geelong, 3220, Australia
Multidisciplinary Alfred Psychiatry Research CentreRecruiting
Melbourne, 3004, Australia
Paratus Clinical Research - MelbourneRecruiting
Melbourne, 3070, Australia
Toowoomba HospitalRecruiting
Toowoomba, 4350, Australia
Westmead HospitalRecruiting
Westmead, 2145, Australia
Hospital das Clínicas da UFMGNot yet recruiting
Belo Horizonte, 30130-100, Brazil
Trial TechRecruiting
Curitiba, 80240-280, Brazil
CliniliveRecruiting
Maringá, 87013-250, Brazil
Centro de Pesquisa Clínica de Marília - CPCLIMRecruiting
Marília, 17504-072, Brazil
Hospital Universitário Onofre LopesRecruiting
Natal, 59012-300, Brazil
Ruschel Medicina e Pesquisa ClínicaRecruiting
Rio de Janeiro, 22270-060, Brazil
Facili Centro Integrado de PsiquiatriaRecruiting
São Bernardo do Campo, 09726-150, Brazil
CPQuali Pesquisa ClínicaRecruiting
São Paulo, 01228-000, Brazil
CPCLINNot yet recruiting
São Paulo, 01228-200, Brazil
BR Trials - Ensaios Clinicos e ConsultoriaRecruiting
São Paulo, 01236030, Brazil
A2Z Clinical Centro Avançado De Pesquisa Clínica - ValinhosRecruiting
Valinhos, 13271-130, Brazil
Heritage Medical Research ClinicNot yet recruiting
Calgary, T2N 4Z6, Canada
Premier Clinical Trial NetworkNot yet recruiting
Hamilton, L8L 5G4, Canada
Kelowna Health and Memory CentreNot yet recruiting
Kelowna, V1Y 5A8, Canada
Alpha Recherche Clinique - LévisRecruiting
Lévis, G6V 0C9, Canada
Genge PartnersNot yet recruiting
Montreal, H4A 3T2, Canada
Dar Clinical Research - OttawaRecruiting
Ottawa, K2J 3Z6, Canada
Centre de Recherche Saint-Louis inc.Not yet recruiting
Québec, G1W 4R4, Canada
Alpha Recherche CliniqueRecruiting
Québec, G2J 0C4, Canada
ALPHA Recherche CliniqueRecruiting
Québec, G3K 2P8, Canada
Richmond Clinical TrialsRecruiting
Richmond, V6V 2L1, Canada
Bluewater Clinical Research Group Inc.Not yet recruiting
Sarnia, N7T 4X3, Canada
Diex Recherche SherbrookeSuspended
Sherbrooke, J1L 0H8, Canada
Centre for Neurology StudiesNot yet recruiting
Surrey, V3V 0E8, Canada
Maple Leaf ResearchSuspended
Toronto, M5G 1K2, Canada
Beijing Anding Hospital - Affiliated Capital University of Medical ScienceRecruiting
Beijing, 100088, China
Beijing HuiLongGuan HospitalRecruiting
Beijing, 100096, China
The Second People's Hospital of Hunan ProvinceRecruiting
Changsha, 410007, China
The Fourth People's Hospital of ChengduRecruiting
Chengdu, 610036, China
Guangzhou Brain HospitalRecruiting
Guangzhou, 510370, China
Peking University Sixth HospitalRecruiting
Haidian District, 100191, China
Hongyan ZhangPrincipal Investigator
Hefei No.4 People's HospitalRecruiting
Hefei, 230061, China
3rd People's Hospital of HuzhouRecruiting
Huzhou, 313000, China
Shandong Daizhuang HospitalRecruiting
Jining, 272051, China
The First Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, 330000, China
The Affilicated Kangning Hospital of Ningbo UniversityRecruiting
Ningbo, 315201, China
Shanghai Mental Health CenterRecruiting
Shanghai, 200030, China
The First Hospital of Hebei Medical UniversityRecruiting