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RECRUITING
NCT07412756
PHASE3

A Study of Brenipatide in Adult Participants With Major Depressive Disorder

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

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

2026-03-23

Healthy Volunteers

No

Interventions

DRUG

Brenipatide

Administered SC

DRUG

Placebo

Administered SC

Locations (186)

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

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

Suburban Research Associates

Media, Pennsylvania, United States

Penn Medicine: University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

K2 Medical Research - East Providence

East Providence, Rhode Island, 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

Mater Misericordiae Limited

Brisbane, Australia

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

Mildura Base Hospital

Mildura, Australia

Toowoomba Hospital

Toowoomba, Australia

Innovate Clinical Research

Waitara, 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

Winterberry Research Inc.

Hamilton, Canada

Premier Clinical Trial Network

Hamilton, 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

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

Zhumadian Psychiatric Hospital

Zhumadian, China

Universitätsklinikum Aachen

Aachen, Germany

FutureMeds GmbH

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

General Hospital of Tripoli Panarkadiko Evangelistria

Tripoli, Greece

Abe Clinic - Arakawa

Arakawa City, Japan

Uematsu Mental Clinic

Chikugo, Japan

Jimbocho Mental Clinic

Chiyoda City, Japan

Fukuoka University Hospital

Fukuoka, Japan

Kokorono Clinic Hirao

Fukuoka, Japan

Horikoshi Mental Somatic Clinic

Fukushima, Japan

University of the Ryukyus Hospital

Ginowan, Japan

Fujimidai Hospital

Hiratsuka, Japan

Rainbow and Sea Hospital

Karatsu, Japan

Kishiro Mental Clinic

Kawasaki, Japan

Monzen-nakacho Mental Clinic

Kōtō City, Japan

Yuge Hospital

Kumamoto, Japan

Suizenji Life Clinic

Kumamoto, Japan

Kure Medical Center

Kure, Japan

Hirota Clinic

Kurume, Japan

Senzoku Psychosomatic Medicine Clinic

Meguro-ku, Japan

Arata Clinic

Nagasaki, Japan

Yutaka Clinic

Sagamihara, Japan

Sangenjaya Shinkeika Shinryonaika Clinic

Setagaya City, Japan

Maynds Tower Mental Clinic

Shibuya-ku, Japan

Nanko Kokorono Clinic

Shirakawa, Japan

Sakurazaka Clinic SophyAnce

Tokyo, Japan

Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi

Tokyo, Japan

Yamagata Sakuracho Hospital

Yamagata, Japan

Miki Mental Clinic

Yokohama, Japan

Shioiri Mental Clinic

Yokosuka, Japan

Scientia Investigacion Clinica S.C.

Chihuahua City, Mexico

Clinica de Investigacion en Reumatologia y Obesidad S. C.

Guadalajara, Mexico

B&B Investigaciones Medicas S.C.

Mazatlán, Mexico

Ketamine Clinic México

Mexico City, Mexico

GabiPros

Mexico City, Mexico

Medical Care and Research SA de CV

Mérida, Mexico

Centro de Investigacion Clinica Chapultepec

Morelia, Mexico

Arké SMO S.A de C.V

Veracruz, Mexico

Instituto Jalisciense de Salud Mental

Zapopan, Mexico

Podlaskie Centrum Psychogeriatrii

Bialystok, Poland

MentalMEDIC

Bielsko-Biala, Poland

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Poland

Diamond Clinic

Krakow, Poland

NZOZ Psychiatrycznej Mentis

Leszno, Poland

Centrum Medyczne Luxmed

Lublin, Poland

Private Practice - Dr. Małgorzata Wojtanowska-Bogacka

Poznan, Poland

Centrum Medyczne Euromedis

Szczecin, Poland

Medical Concierge Centrum Medyczne

Warsaw, Poland

Centrum Medyczne Ginemedica

Wroclaw, Poland

Clinhouse Centrum Medyczne

Zabrze, Poland

SCB Research Center

Bayamón, Puerto Rico

Korea University Ansan Hospital

Ansan-si, South Korea

Chonnam National University Hospital

Gwangju, South Korea

Jeju National University Hospital

Jeju City, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Konkuk University Medical Center

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic Univ. of Korea Seoul St. Mary's Hospital

Seoul, South Korea

Parc de Salut Mar - Hospital del Mar

Barcelona, Spain

Institucion Hosp Hestia Palau

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitario Infanta Leonor

Madrid, Spain

Centro de Atención Integral La Corredoria

Oviedo, Spain

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, Spain

Hospital Universitario de Araba (HUA)- Hospital Txagorritxu

Vitoria-Gasteiz, Spain

Complejo Asistencial de Zamora

Zamora, Spain

Keelung Chang Gung Memorial Hospital

Keelung, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Cheng Hsin General Hospital

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, Taiwan

Edinburgh Royal Infirmary

Edinburgh, United Kingdom

Devon Partnership Trust

Exeter, United Kingdom

Queen Elizabeth University Hospital

Glasgow, United Kingdom

The Maudsley Hospital

London, United Kingdom

Clerkenwell Health - London - Welbeck Street

London, United Kingdom

Queen's Medical Centre, Nottingham University Hospitals

Nottingham, United Kingdom

Warneford Hospital

Oxford, United Kingdom

St Bartholomew's Medical Centre

Oxford, United Kingdom

Atlantic Medical

Penzance, United Kingdom

Woodstock Bower Surgery

Rotherham, United Kingdom