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NCT07775300PHASE3Recruiting

A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder

Eli Lilly and Company

Start Date

8/14/2026

Completion Date

2/1/2029

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.

Eligibility Criteria

Age Range: 18 years to 75 years

Inclusion Criteria: * Meet the diagnostic criteria for major depressive disorder * Are on 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 spectrum 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

Interventions

DRUG

Brenipatide

DRUG

Placebo

Interested in This Trial?

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Conditions

Depressive Disorder, Major

Locations

University of Alabama at Birmingham - School of Medicine

Birmingham, Alabama 35294

United States

NoesisPharma, LLC

Phoenix, Arizona 85028

United States

Irvine Clinical Research

Irvine, California 92614

United States

Healthy Brain Clinic

Long Beach, California 90804

United States

Oakland Clinical

Oakland, California 94609

United States

Concierge Clinical Trials

Valley Village, California 91607

United States

JEM Research Institute

Atlantis, Florida 33462

United States

Bradenton Research Center, Inc.

Bradenton, Florida 34205

United States

Key Clinical Research

Bradenton, Florida 34207

United States

NextPhase Research Florida - Hollywood

Hollywood, Florida 33024

United States

Miami Jewish health

Miami, Florida 33137

United States

Quantix Research - Miami - Southwest 72nd Street

Miami, Florida 33173

United States

Diverse Clinical Research

Miami, Florida 33175

United States

CLA Research

Naples, Florida 34116

United States

Health Synergy Clinical Research

West Palm Beach, Florida 33407

United States

CenExel iResearch, LLC

Decatur, Georgia 30030

United States

AGILE Clinical Research Trials, LLC

Sandy Springs, Georgia 30328

United States

Charter Research - Chicago

Chicago, Illinois 60618

United States

Pharmasite Research, Inc.

Baltimore, Maryland 21208

United States

Adams Clinical Boston

Boston, Massachusetts 02116

United States

Adams Clinical Watertown

Watertown, Massachusetts 02472

United States

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan 48098

United States

Be Well Clinical Studies - Omaha

Omaha, Nebraska 68144

United States

Adams Clinical Bronx

The Bronx, New York 10461

United States

Adams Clinical Philadelphia

Philadelphia, Pennsylvania 19104

United States

Penn Medicine: University of Pennsylvania Health System

Philadelphia, Pennsylvania 19104

United States

Suburban Research Associates

West Chester, Pennsylvania 19380

United States

FutureSearch Trials of Neurology

Austin, Texas 78731

United States

Gadolin Research

Beaumont, Texas 77702

United States

Adams Clinical Dallas

DeSoto, Texas 75115

United States

The University of Texas Rio Grande Valley

Harlingen, Texas 78550

United States

Olympus Clinical Research

Katy, Texas 77450

United States

Boeson Research - Provo

Provo, Utah 84604

United States

Northwest Clinical Research Center

Bellevue, Washington 98007

United States

Ramsay Clinic New Farm

Brisbane, 4005

Australia

Paratus Clinical Research Canberra

Bruce, 2617

Australia

NeuroCentrix

Carlton, 3053

Australia

Lyell McEwin Hospital

Elizabeth Vale, 5112

Australia

Barwon Health

Geelong, 3220

Australia

Multidisciplinary Alfred Psychiatry Research Centre

Melbourne, 3004

Australia

Ramsay Clinic Albert Road

Melbourne, 3004

Australia

Toowoomba Hospital

Toowoomba, 4350

Australia

Westmead Hospital

Westmead, 2145

Australia

Instituto de Pesquisa clinica de Campinas

Campinas, 13060-080

Brazil

Cline Research Center

Curitiba, 80030-480

Brazil

Clínica Neurológica

Joinville, 89202190

Brazil

Instituto Méderi de Pesquisa e Saúde

Passo Fundo, 99010-120

Brazil

Hospital das Clínicas - UFPE

Recife, 50670-420

Brazil

Centro Multidisciplinar de Estudos Clinicos

São Bernardo do Campo, 09715-090

Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, 15090000

Brazil

PSEG Centro de Pesquisa Clínica

São Paulo, 04038-002

Brazil

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, 04266-010

Brazil

CEDOES

Vitória, 29055450

Brazil

Integral Pesquisa e Ensino

Votuporanga, 15500-269

Brazil

CaRe Clinic

Calgary, T2N 4L7

Canada

Kelowna Health and Memory Centre

Kelowna, V1Y 5A8

Canada

Providence Care

Kingston, K7L 4X3

Canada

Alpha Recherche Clinique - Lévis

Lévis, G6V 0C9

Canada

AMNDX

Markham, L3R 1A3

Canada

Malton Medical Group

Mississauga, L4T 4J2

Canada

Alpha Recherche Clinique

Québec, G2J 0C4

Canada

ALPHA Recherche Clinique

Québec, G3K 2P8

Canada

Richmond Clinical Trials

Richmond, V6V 2L1

Canada

Research, Innovation, Science and Excellence (RISE) Institute

Toronto, L5L 1W8

Canada

Beijing Anding Hospital - Affiliated Capital University of Medical Science

Beijing, 100088

China

Chaohu Hospital of Anhui Medical University

Chaohu, 238001

China

Shandong Mental Health Center

Jinan, 250012

China

Linfen Central Hospital

Linfen, 041000

China

Shanghai Tongji Hospital

Shanghai, 200065

China

Suzhou Guangji Hospital

Suzhou, 215003

China

Tianjin Anding Hospital

Tianjin, 300022

China

The Affiliated Kangning Hospital of Wenzhou Medical University

Wenzhou, 325007

China

Wuhu Hospital of Beijing Anding hospital

Wuhu, 242407

China

Zhenjiang Mental Health Center

Zhenjiang, 212000

China

FutureMeds Berlin

Berlin, 10629

Germany

Charite Universitätsmedizin Berlin Campus Benjamin Franklin

Berlin, 12203

Germany

Pharmakologisches Studienzentrum Chemnitz

Chemnitz, 09111

Germany

Klinische Forschung Hamburg

Hamburg, 20253

Germany

Universitätsklinikum Leipzig

Leipzig, 04103

Germany

Somni bene

Schwerin, 19053

Germany

Argolida General Hospital

Argos, 212 00

Greece

Multidisciplinary Mental Health Hospital of Attiki

Athens, 124 62

Greece

Sismanogleio General Hospital of Attiki

Athens, 151 26

Greece

Attikon General University Hospital

Chaïdári, 124 62

Greece

University Hospital of Ioannina

Ioannina, 455 00

Greece

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, 564 29

Greece

Medical corporation Shinseikai Kaku Mental Clinic

Fukuoka, 810-0022

Japan

Kuramitsu Hospital

Fukuoka, 819-0037

Japan

UNB Sumiyoshi Jinjamae Clinic

Hakata-Ku, 812-0018

Japan

Hinotoyoda Cocoro Clinic

Hino, 191-0062

Japan

Rainbow and Sea Hospital

Karatsu, 847-0031

Japan

Kishiro Mental Clinic

Kawasaki, 214-0014

Japan

Hiiragi Kokoro Clinic - Kokurain

Kitakyushu, 802-0001

Japan

Juntendo Koshigaya Hospital

Koshigaya, 343-0032

Japan

Monzen-nakacho Mental Clinic

Kōtō City, 135-0047

Japan

National Hospital Organization Shimofusa Psychiatric Medical Center

MIdori-ku, Chiba-shi, 266-0007

Japan

Tokyo Nakano Mental Clinic

Nakano City, 164-0001

Japan

Watanabe Clinic

Osaka, 541-0043

Japan

Yutaka Clinic

Sagamihara, 252-0303

Japan

Kitasato University Hospital

Sagamihara, 252-0375

Japan

Maynds Tower Mental Clinic

Shibuya-ku, 151-0053

Japan

Etoh Mentalclinic Meguro

Shinagawa City, 141-0021

Japan

Tokumoto Komorebi Clinic

Suita, 564-0063

Japan

Sangenjaya Nakamura Mental Clinic

Tokyo, 154-0004

Japan

Ikebukuro Olive Mental Clinic

Toshima City, 170-0013

Japan

Miki Mental Clinic

Yokohama, 220-0023

Japan

Yokohama Mental Clinic Totsuka

Yokohama, 244-0816

Japan

Scientia Investigacion Clinica S.C.

Chihuahua City, 31207

Mexico

Scientia Investigacion Clinica Tj

Ciudad de Tijuana, 22105

Mexico

Investigación Clínica Cuernavaca, S.C.

Cuernavaca, 62448

Mexico

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

Culiacán, 80230

Mexico

RM Pharma Specialists

Mexico City, 03100

Mexico

Ketamine Clinic México

Mexico City, 04100

Mexico

Human Science Research Trials

Mexico City, 14050

Mexico

Medical Care and Research SA de CV

Mérida, 97070

Mexico

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

Veracruz, 91900

Mexico

Núcleo de Investigación Médica Sur de Guadalajara

Zapopan, 45070

Mexico

Podlaskie Centrum Psychogeriatrii

Bialystok, 15-756

Poland

MentalMEDIC

Bielsko-Biala, 43-300

Poland

IN VIVO

Bydgoszcz, 85-048

Poland

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

Gdansk, 80-546

Poland

Diamond Clinic

Krakow, 31-559

Poland

NZOZ Psychiatrycznej Mentis

Leszno, 64-100

Poland

Santa Familia PTG Lodz

Lodz, 90-302

Poland

Nowy Szpital w Olkuszu

Olkusz, 32-300

Poland

Private Practice - Dr. Małgorzata Wojtanowska-Bogacka

Poznan, 60-192

Poland

Centrum Medyczne Ginemedica

Wroclaw, 50-414

Poland

Clinhouse Centrum Medyczne

Zabrze, 41-807

Poland

INSPIRA Clinical Research

San Juan, 00918

Puerto Rico

Instituto De Neurologia Dra. Ivonne Fraga

San Juan, 00918

Puerto Rico

Barbara Diaz-Hernandez MD Research, Inc.

San Juan, 00926

Puerto Rico

Korea University Ansan Hospital

Ansan-si, 15355

South Korea

Chonnam National University Hospital

Gwangju, 61469

South Korea

Jeju National University Hospital

Jeju City, 63241

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Konkuk University Medical Center

Seoul, 05030

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

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

Seoul, 06591

South Korea

Parc de Salut Mar - Hospital del Mar

Barcelona, 08003

Spain

Institucion Hosp Hestia Palau

Barcelona, 08025

Spain

Parc Sanitari Sant Joan de Déu

Barcelona, 08029

Spain

Hospital Clínic de Barcelona

Barcelona, 08036

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041

Spain

EAP Osona Sud - Alt Congost S.L.P

Centelles, 08540

Spain

Hospital Universitario Infanta Leonor

Madrid, 28031

Spain

Centro de Salud Mental (CSM) La Corredoria

Oviedo, 33011

Spain

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, 37005

Spain

Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

Seville, 41003

Spain

Hospital Universitario Virgen Del Rocio

Seville, 41013

Spain

Complejo Asistencial de Zamora

Zamora, 49021

Spain

Keelung Chang Gung Memorial Hospital

Keelung, 204

Taiwan

Chung Shan Medical University Hospital

Taichung, 402

Taiwan

Taichung Veterans General Hospital

Taichung, 407

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Cheng Hsin General Hospital

Taipei, 112

Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333

Taiwan

Bodmin Community Hospital

Bodmin, PL31 2QT

United Kingdom

Edinburgh Royal Infirmary

Edinburgh, EH16 4SA

United Kingdom

Devon Partnership Trust

Exeter, EX2 5AF

United Kingdom

Queen Elizabeth University Hospital

Glasgow, G51 4TF

United Kingdom

Avrin - Liverpool

Liverpool, L24 7RB

United Kingdom

NeuroClnx

Motherwell, ML1 4UF

United Kingdom

St Bartholomew's Medical Centre

Oxford, OX4 1XB

United Kingdom

Atlantic Medical

Penzance, TR18 3DX

United Kingdom

Ascend Clinical Research

Reading, RG7 8PA

United Kingdom

Woodstock Bower Surgery

Rotherham, S61 1AH

United Kingdom