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A Study of Brenipatide in Adult Participants With Major Depressive Disorder
Sponsor: Eli Lilly and Company
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 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.
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)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2026-02-09
Completion Date
2028-02
Last Updated
2026-10-05
Healthy Volunteers
No
Conditions
Interventions
Brenipatide
Administered SC
Placebo
Administered SC
Locations (181)
Accellacare - Moorpark
Moorpark, California, United States
ATP Clinical Research
Orange, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Encore Medical Research
Hollywood, Florida, United States
K2 Medical Research - Maitland
Maitland, Florida, United States
Life Medical Research Group Corp
Miami Gardens, Florida, United States
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States
CLA Research
Naples, Florida, United States
Optimal Research Sites
Orange City, Florida, United States
Charter Research - Orlando
Orlando, Florida, United States
K2 Medical Research - Tampa
Tampa, Florida, United States
CenExel iResearch, LLC
Decatur, Georgia, United States
Indiana University Health Neuroscience Center
Indianapolis, Indiana, United States
Cedar Valley Medical Specialists
Waterloo, Iowa, United States
Pharmasite Research, Inc.
Baltimore, Maryland, United States
Adams Clinical Boston
Boston, Massachusetts, United States
K2 Medical Research - Foxborough
Foxborough, Massachusetts, United States
Adams Clinical Watertown
Watertown, Massachusetts, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
Arch Clinical Trials
St Louis, Missouri, United States
Vector Clinical Trials
Las Vegas, Nevada, United States
Adams Clinical Harlem
New York, New York, United States
Summit Headlands
Portland, Oregon, United States
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Suburban Research Associates
West Chester, Pennsylvania, United States
Circle Clinical Research
Sioux Falls, South Dakota, United States
Adams Clinical Dallas
DeSoto, Texas, United States
Re:Cognition Health - Fort Worth
Fort Worth, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Alpine Research Organization
Clinton, Utah, United States
Re:Cognition Health
Fairfax, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
NeuroCentrix
Carlton, Australia
Lyell McEwin Hospital
Elizabeth Vale, Australia
Barwon Health
Geelong, Australia
Multidisciplinary Alfred Psychiatry Research Centre
Melbourne, Australia
Paratus Clinical Research - Melbourne
Melbourne, Australia
Toowoomba Hospital
Toowoomba, Australia
Westmead Hospital
Westmead, Australia
Hospital das Clínicas da UFMG
Belo Horizonte, Brazil
Trial Tech
Curitiba, Brazil
Clinilive
Maringá, Brazil
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, Brazil
Hospital Universitário Onofre Lopes
Natal, Brazil
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, Brazil
Facili Centro Integrado de Psiquiatria
São Bernardo do Campo, Brazil
CPQuali Pesquisa Clínica
São Paulo, Brazil
CPCLIN
São Paulo, Brazil
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, Brazil
A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos
Valinhos, Brazil
Heritage Medical Research Clinic
Calgary, Canada
Hamilton Medical Research Group
Hamilton, Canada
Kelowna Health and Memory Centre
Kelowna, Canada
Alpha Recherche Clinique - Lévis
Lévis, Canada
Genge Partners
Montreal, Canada
Dar Clinical Research - Ottawa
Ottawa, Canada
Centre de Recherche Saint-Louis inc.
Québec, Canada
Alpha Recherche Clinique
Québec, Canada
ALPHA Recherche Clinique
Québec, Canada
Richmond Clinical Trials
Richmond, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Canada
Diex Recherche Sherbrooke
Sherbrooke, Canada
Centre for Neurology Studies
Surrey, Canada
Maple Leaf Research
Toronto, Canada
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing, China
Beijing HuiLongGuan Hospital
Beijing, China
The Second People's Hospital of Hunan Province
Changsha, China
Chaohu Hospital of Anhui Medical University
Chaohu, China
The Fourth People's Hospital of Chengdu
Chengdu, China
Guangzhou Brain Hospital
Guangzhou, China
Peking University Sixth Hospital
Haidian District, China
Hefei No.4 People's Hospital
Hefei, China
3rd People's Hospital of Huzhou
Huzhou, China
Shandong Daizhuang Hospital
Jining, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
The Affilicated Kangning Hospital of Ningbo University
Ningbo, China
Shanghai Mental Health Center
Shanghai, China
The First Hospital of Hebei Medical University
Shijiazhuang, China
Suzhou Guangji Hospital
Suzhou, China
Tianjin Anding Hospital
Tianjin, China
Renmin Hospital of Wuhan University
Wuhan, China
Wuxi Mental Health Center
Wuxi, China
Xi An Mental Health Center
Xi'an, China
Xianyang Hospital of Yan'an University
Xianyang, China
Zhenjiang Mental Health Center
Zhenjiang, China
Zhumadian Psychiatric Hospital
Zhumadian, China
Universitätsklinikum Aachen
Aachen, Germany
FutureMeds Berlin
Berlin, Germany
Neurozentrum Bielefeld
Bielefeld, Germany
Pharmakologisches Studienzentrum Chemnitz
Chemnitz, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Germany
ISPG - Institut für Studien zur Psychischen Gesundheit
Mannheim, Germany
Somni bene
Schwerin, Germany
ZNS Siegen
Siegen, Germany
Argolida General Hospital
Argos, Greece
Aiginiteio University Hospital
Athens, Greece
Multidisciplinary Mental Health Hospital of Attiki
Athens, Greece
Attikon General University Hospital
Chaïdári, Greece
Multidisciplinary Mental Health Hospital of Thessaloniki
Stavroupoli, Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, Greece