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NOT YET RECRUITING
NCT07775300
PHASE3

A Study of Brenipatide (LY3537031) 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- 2)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2026-08

Completion Date

2029-02

Last Updated

2026-08-20

Healthy Volunteers

No

Interventions

DRUG

Brenipatide

Administered SC.

DRUG

Placebo

Administered SC.

Locations (169)

University of Alabama at Birmingham - School of Medicine

Birmingham, Alabama, United States

NoesisPharma, LLC

Phoenix, Arizona, United States

Irvine Clinical Research

Irvine, California, United States

Healthy Brain Clinic

Long Beach, California, United States

Oakland Clinical

Oakland, California, United States

Concierge Clinical Trials

Valley Village, California, United States

JEM Research Institute

Atlantis, Florida, United States

Bradenton Research Center, Inc.

Bradenton, Florida, United States

Key Clinical Research

Bradenton, Florida, United States

NextPhase Research Florida - Hollywood

Hollywood, Florida, United States

Miami Jewish health

Miami, Florida, United States

Quantix Research - Miami - Southwest 72nd Street

Miami, Florida, United States

Diverse Clinical Research

Miami, Florida, United States

De La Cruz Research Center, LLC

Miami, Florida, United States

CLA Research

Naples, Florida, United States

Charter Research - Orlando

Orlando, Florida, United States

Health Synergy Clinical Research

West Palm Beach, Florida, United States

AGILE Clinical Research Trials, LLC

Sandy Springs, Georgia, United States

Charter Research - Chicago

Chicago, Illinois, 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

Be Well Clinical Studies - Omaha

Omaha, Nebraska, United States

Adams Clinical Bronx

The Bronx, New York, United States

Lehigh Center for Clinical Research

Allentown, Pennsylvania, United States

Suburban Research Associates

Media, Pennsylvania, United States

Adams Clinical Philadelphia

Philadelphia, Pennsylvania, United States

Penn Medicine: University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Gadolin Research

Beaumont, Texas, United States

Adams Clinical Dallas

DeSoto, Texas, United States

The University of Texas Rio Grande Valley

Harlingen, Texas, United States

Olympus Clinical Research

Katy, Texas, United States

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Boeson Research - Provo

Provo, Utah, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Ramsay Clinic New Farm

Brisbane, Australia

Paratus Clinical Research Canberra

Bruce, Australia

NeuroCentrix

Carlton, Australia

Lyell McEwin Hospital

Elizabeth Vale, Australia

Peninsula Therapeutic & Research Group

Frankston, Australia

Barwon Health

Geelong, Australia

Multidisciplinary Alfred Psychiatry Research Centre

Melbourne, Australia

Ramsay Clinic Albert Road

Melbourne, Australia

Toowoomba Hospital

Toowoomba, Australia

Westmead Hospital

Westmead, Australia

Instituto de Pesquisa clinica de Campinas

Campinas, Brazil

Cline Research Center

Curitiba, Brazil

Clínica Neurológica

Joinville, Brazil

Instituto Méderi de Pesquisa e Saúde

Passo Fundo, Brazil

Hospital das Clínicas - UFPE

Recife, Brazil

Centro Multidisciplinar de Estudos Clinicos

São Bernardo do Campo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, Brazil

PSEG Centro de Pesquisa Clínica

São Paulo, Brazil

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, Brazil

CEDOES

Vitória, Brazil

Integral Pesquisa e Ensino

Votuporanga, Brazil

CaRe Clinic

Calgary, Canada

Kelowna Health and Memory Centre

Kelowna, Canada

Providence Care

Kingston, Canada

Alpha Recherche Clinique - Lévis

Lévis, Canada

AMNDX

Markham, Canada

Malton Medical Group

Mississauga, Canada

Alpha Recherche Clinique

Québec, Canada

ALPHA Recherche Clinique

Québec, Canada

Richmond Clinical Trials

Richmond, Canada

Research, Innovation, Science and Excellence (RISE) Institute

Toronto, Canada

Beijing Anding Hospital - Affiliated Capital University of Medical Science

Beijing, China

Anhui Medical University - Chaohu Hospital

Chaohu, China

Shandong Mental Health Center

Jinan, China

Linfen Central Hospital

Linfen, China

Shanghai Tongji Hospital

Shanghai, China

Suzhou Guangji Hospital

Suzhou, China

Tianjin Anding Hospital

Tianjin, China

The Affiliated Kangning Hospital of Wenzhou Medical University

Wenzhou, China

Wuhu Hospital of Beijing Anding hospital

Wuhu, China

Zhenjiang Mental Health Center

Zhenjiang, China

FutureMeds GmbH

Berlin, Germany

Charite Universitätsmedizin Berlin Campus Benjamin Franklin

Berlin, Germany

Pharmakologisches Studienzentrum Chemnitz

Chemnitz, Germany

Klinische Forschung Hamburg

Hamburg, Germany

Universitätsklinikum Leipzig

Leipzig, Germany

Somni bene

Schwerin, Germany

Argolida General Hospital

Argos, Greece

Multidisciplinary Mental Health Hospital of Attiki

Athens, Greece

Sismanogleio General Hospital of Attiki

Athens, Greece

Attikon General University Hospital

Chaïdári, Greece

University Hospital of Ioannina

Ioannina, Greece

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, Greece

General Hospital of Tripoli Panarkadiko Evangelistria

Tripoli, Greece

Medical corporation Shinseikai Kaku Mental Clinic

Fukuoka, Japan

Kuramitsu Hospital

Fukuoka, Japan

Hinotoyoda Cocoro Clinic

Hino, Japan

Rainbow and Sea Hospital

Karatsu, Japan

Kishiro Mental Clinic

Kawasaki, Japan

Hiiragi Kokoro Clinic - Kokurain

Kitakyushu, Japan

Monzen-nakacho Mental Clinic

Kōtō City, Japan

National Hospital Organization Shimofusa Psychiatric Medical Center

MIdori-ku, Chiba-shi, Japan

Tokyo Nakano Mental Clinic

Nakano City, Japan

Watanabe Clinic

Osaka, Japan

Yutaka Clinic

Sagamihara, Japan

Kitasato University Hospital

Sagamihara, Japan

Maynds Tower Mental Clinic

Shibuya-ku, Japan

Etoh Mentalclinic Meguro

Shinagawa City, Japan

Tokumoto Komorebi Clinic

Suita, Japan

Sangenjaya Nakamura Mental Clinic

Tokyo, Japan

Miki Mental Clinic

Yokohama, Japan

Scientia Investigacion Clinica S.C.

Chihuahua City, Mexico

Scientia Investigacion Clinica Tj

Ciudad de Tijuana, Mexico

Investigación Clínica Cuernavaca, S.C.

Cuernavaca, Mexico

Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.

Culiacán, Mexico

RM Pharma Specialists

Mexico City, Mexico

Ketamine Clinic México

Mexico City, Mexico

Human Science Research Trials

Mexico City, Mexico

Medical Care and Research SA de CV

Mérida, Mexico

FAICIC S. de R.L. de C.V.

Veracruz, Mexico

Núcleo de Investigación Médica Sur de Guadalajara

Zapopan, Mexico

Podlaskie Centrum Psychogeriatrii

Bialystok, Poland

MentalMEDIC

Bielsko-Biala, Poland

IN VIVO

Bydgoszcz, Poland

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

Gdansk, Poland

Diamond Clinic

Krakow, Poland

NZOZ Psychiatrycznej Mentis

Leszno, Poland

Santa Familia PTG Lodz

Lodz, Poland

Nowy Szpital w Olkuszu

Olkusz, Poland

Private Practice - Dr. Małgorzata Wojtanowska-Bogacka

Poznan, Poland

Centrum Medyczne Ginemedica

Wroclaw, Poland

Clinhouse Centrum Medyczne

Zabrze, Poland

INSPIRA Clinical Research

San Juan, Puerto Rico

Instituto De Neurologia Dra. Ivonne Fraga

San Juan, Puerto Rico

Barbara Diaz-Hernandez MD Research, Inc.

San Juan, 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

Parc Sanitari Sant Joan de Déu

Barcelona, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

EAP Osona Sud - Alt Congost S.L.P

Centelles, Spain

Hospital Universitario Infanta Leonor

Madrid, Spain

Centro de Salud Mental (CSM) La Corredoria

Oviedo, Spain

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, Spain

Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

Seville, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Complejo Asistencial de Zamora

Zamora, Spain

Keelung Chang Gung Memorial Hospital

Keelung, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Cheng Hsin General Hospital

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, Taiwan

Bodmin Community Hospital

Bodmin, United Kingdom

Edinburgh Royal Infirmary

Edinburgh, United Kingdom

Devon Partnership Trust

Exeter, United Kingdom

Queen Elizabeth University Hospital

Glasgow, United Kingdom

NeuroClnx

Motherwell, United Kingdom

St Bartholomew's Medical Centre

Oxford, United Kingdom

Atlantic Medical

Penzance, United Kingdom

Ascend Clinical Research

Reading, United Kingdom

Woodstock Bower Surgery

Rotherham, United Kingdom