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NCT07412756PHASE3Recruiting

A Study of Brenipatide in Adult Participants With Major Depressive Disorder

Eli Lilly and Company

Start Date

2/9/2026

Completion Date

2/1/2028

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 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

Interventions

DRUG

Brenipatide

DRUG

Placebo

Interested in This Trial?

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Conditions

Depressive Disorder, Major

Locations

Accellacare - Moorpark

Moorpark, California 93021

United States

ATP Clinical Research

Orange, California 92866

United States

Yale University School of Medicine

New Haven, Connecticut 06519

United States

Encore Medical Research

Hollywood, Florida 33024

United States

K2 Medical Research - Maitland

Maitland, Florida 32751

United States

Life Medical Research Group Corp

Miami Gardens, Florida 33014

United States

Floridian Clinical Research, LLC

Miami Lakes, Florida 33016-1518

United States

CLA Research

Naples, Florida 34116

United States

Optimal Research Sites

Orange City, Florida 32763

United States

Charter Research - Orlando

Orlando, Florida 32803

United States

K2 Medical Research - Tampa

Tampa, Florida 33634

United States

CenExel iResearch, LLC

Decatur, Georgia 30030

United States

Indiana University Health Neuroscience Center

Indianapolis, Indiana 46202

United States

Cedar Valley Medical Specialists

Waterloo, Iowa 50701

United States

Pharmasite Research, Inc.

Baltimore, Maryland 21208

United States

Adams Clinical Boston

Boston, Massachusetts 02116

United States

K2 Medical Research - Foxborough

Foxborough, Massachusetts 02035

United States

Adams Clinical Watertown

Watertown, Massachusetts 02472

United States

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan 48098

United States

Arch Clinical Trials

St Louis, Missouri 63141

United States

Vector Clinical Trials

Las Vegas, Nevada 89128

United States

Adams Clinical Harlem

New York, New York 10029

United States

Summit Headlands

Portland, Oregon 97210

United States

Suburban Research Associates

Media, Pennsylvania 19063

United States

Penn Medicine: University of Pennsylvania Health System

Philadelphia, Pennsylvania 19104

United States

Circle Clinical Research

Sioux Falls, South Dakota 57104

United States

Adams Clinical Dallas

DeSoto, Texas 75115

United States

Re:Cognition Health - Fort Worth

Fort Worth, Texas 76104

United States

Consano Clinical Research, LLC

Shavano Park, Texas 78231

United States

Alpine Research Organization

Clinton, Utah 84015

United States

Re:Cognition Health

Fairfax, Virginia 22031

United States

Northwest Clinical Research Center

Bellevue, Washington 98007

United States

NeuroCentrix

Carlton, 3053

Australia

Lyell McEwin Hospital

Elizabeth Vale, 5112

Australia

Barwon Health

Geelong, 3220

Australia

Multidisciplinary Alfred Psychiatry Research Centre

Melbourne, 3004

Australia

Paratus Clinical Research - Melbourne

Melbourne, 3070

Australia

Toowoomba Hospital

Toowoomba, 4350

Australia

Westmead Hospital

Westmead, 2145

Australia

Hospital das Clínicas da UFMG

Belo Horizonte, 30130-100

Brazil

Trial Tech

Curitiba, 80240-280

Brazil

Clinilive

Maringá, 87013-250

Brazil

Centro de Pesquisa Clínica de Marília - CPCLIM

Marília, 17504-072

Brazil

Hospital Universitário Onofre Lopes

Natal, 59012-300

Brazil

Ruschel Medicina e Pesquisa Clínica

Rio de Janeiro, 22270-060

Brazil

Facili Centro Integrado de Psiquiatria

São Bernardo do Campo, 09726-150

Brazil

CPQuali Pesquisa Clínica

São Paulo, 01228-000

Brazil

CPCLIN

São Paulo, 01228-200

Brazil

BR Trials - Ensaios Clinicos e Consultoria

São Paulo, 01236030

Brazil

A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos

Valinhos, 13271-130

Brazil

Heritage Medical Research Clinic

Calgary, T2N 4Z6

Canada

Premier Clinical Trial Network

Hamilton, L8L 5G4

Canada

Kelowna Health and Memory Centre

Kelowna, V1Y 5A8

Canada

Alpha Recherche Clinique - Lévis

Lévis, G6V 0C9

Canada

Genge Partners

Montreal, H4A 3T2

Canada

Dar Clinical Research - Ottawa

Ottawa, K2J 3Z6

Canada

Centre de Recherche Saint-Louis inc.

Québec, G1W 4R4

Canada

Alpha Recherche Clinique

Québec, G2J 0C4

Canada

ALPHA Recherche Clinique

Québec, G3K 2P8

Canada

Richmond Clinical Trials

Richmond, V6V 2L1

Canada

Bluewater Clinical Research Group Inc.

Sarnia, N7T 4X3

Canada

Diex Recherche Sherbrooke

Sherbrooke, J1L 0H8

Canada

Centre for Neurology Studies

Surrey, V3V 0E8

Canada

Maple Leaf Research

Toronto, M5G 1K2

Canada

Beijing Anding Hospital - Affiliated Capital University of Medical Science

Beijing, 100088

China

Beijing HuiLongGuan Hospital

Beijing, 100096

China

The Second People's Hospital of Hunan Province

Changsha, 410007

China

The Fourth People's Hospital of Chengdu

Chengdu, 610036

China

Guangzhou Brain Hospital

Guangzhou, 510370

China

Peking University Sixth Hospital

Haidian District, 100191

China

Hefei No.4 People's Hospital

Hefei, 230061

China

3rd People's Hospital of Huzhou

Huzhou, 313000

China

Shandong Daizhuang Hospital

Jining, 272051

China

The First Affiliated Hospital of Nanchang University

Nanchang, 330000

China

The Affilicated Kangning Hospital of Ningbo University

Ningbo, 315201

China

Shanghai Mental Health Center

Shanghai, 200030

China

The First Hospital of Hebei Medical University

Shijiazhuang, 050031

China

Suzhou Guangji Hospital

Suzhou, 215003

China

Tianjin Anding Hospital

Tianjin, 300022

China

Renmin Hospital of Wuhan University

Wuhan, 430060

China

Wuxi Mental Health Center

Wuxi, 214151

China

Xi An Mental Health Center

Xi'an, 710061

China

Xianyang Hospital of Yan'an University

Xianyang, 712000

China

Zhumadian Psychiatric Hospital

Zhumadian, 463000

China

Universitätsklinikum Aachen

Aachen, 52074

Germany

FutureMeds GmbH

Berlin, 10629

Germany

Neurozentrum Bielefeld

Bielefeld, 33647

Germany

Pharmakologisches Studienzentrum Chemnitz

Chemnitz, 09111

Germany

Universitätsmedizin Johannes Gutenberg Universität Mainz

Mainz, 55131

Germany

ISPG - Institut für Studien zur Psychischen Gesundheit

Mannheim, 68165

Germany

Somni bene

Schwerin, 19053

Germany

ZNS Siegen

Siegen, 57076

Germany

Argolida General Hospital

Argos, 212 00

Greece

Aiginiteio University Hospital

Athens, 115 28

Greece

Multidisciplinary Mental Health Hospital of Attiki

Athens, 124 62

Greece

Attikon General University Hospital

Chaïdári, 124 62

Greece

Multidisciplinary Mental Health Hospital of Thessaloniki

Stavroupoli, 564 29

Greece

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, 564 29

Greece

General Hospital of Tripoli Panarkadiko Evangelistria

Tripoli, 221 00

Greece

Abe Clinic - Arakawa

Arakawa City, 116-0014

Japan

Uematsu Mental Clinic

Chikugo, 833-0041

Japan

Jimbocho Mental Clinic

Chiyoda City, 101-0051

Japan

Fukuoka University Hospital

Fukuoka, 814-0180

Japan

Kokorono Clinic Hirao

Fukuoka, 815-0071

Japan

Horikoshi Mental Somatic Clinic

Fukushima, 960-8053

Japan

University of the Ryukyus Hospital

Ginowan, 901-2725

Japan

Fujimidai Hospital

Hiratsuka, 259-1205

Japan

Rainbow and Sea Hospital

Karatsu, 847-0031

Japan

Kishiro Mental Clinic

Kawasaki, 214-0014

Japan

Monzen-nakacho Mental Clinic

Kōtō City, 135-0047

Japan

Yuge Hospital

Kumamoto, 861-8002

Japan

Suizenji Life Clinic

Kumamoto, 862-0956

Japan

Kure Medical Center

Kure, 737-0023

Japan

Hirota Clinic

Kurume, 830-0033

Japan

Senzoku Psychosomatic Medicine Clinic

Meguro-ku, 152-0012

Japan

Arata Clinic

Nagasaki, 852-8137

Japan

Yutaka Clinic

Sagamihara, 252-0303

Japan

Sangenjaya Shinkeika Shinryonaika Clinic

Setagaya City, 154-0004

Japan

Maynds Tower Mental Clinic

Shibuya-ku, 151-0053

Japan

Nanko Kokorono Clinic

Shirakawa, 961-0021

Japan

Sakurazaka Clinic SophyAnce

Tokyo, 106-0032

Japan

Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi

Tokyo, 162-0843

Japan

Yamagata Sakuracho Hospital

Yamagata, 990-0045

Japan

Miki Mental Clinic

Yokohama, 220-0023

Japan

Shioiri Mental Clinic

Yokosuka, 238-0042

Japan

Scientia Investigacion Clinica S.C.

Chihuahua City, 31207

Mexico

Clinica de Investigacion en Reumatologia y Obesidad S. C.

Guadalajara, 44650

Mexico

B&B Investigaciones Medicas S.C.

Mazatlán, 82103

Mexico

Ketamine Clinic México

Mexico City, 04100

Mexico

GabiPros

Mexico City, 07000

Mexico

Medical Care and Research SA de CV

Mérida, 97070

Mexico

Centro de Investigacion Clinica Chapultepec

Morelia, 58260

Mexico

Arké SMO S.A de C.V

Veracruz, 91900

Mexico

Podlaskie Centrum Psychogeriatrii

Bialystok, 15-756

Poland

MentalMEDIC

Bielsko-Biala, 43-300

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

Private Practice - Dr. Małgorzata Wojtanowska-Bogacka

Poznan, 60-192

Poland

Centrum Medyczne Euromedis

Szczecin, 70-111

Poland

Medical Concierge Centrum Medyczne

Warsaw, 02-798

Poland

Centrum Medyczne Ginemedica

Wroclaw, 50-414

Poland

Clinhouse Centrum Medyczne

Zabrze, 41-807

Poland

SCB Research Center

Bayamón, 00961

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

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Clínic de Barcelona

Barcelona, 08036

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041

Spain

Hospital Universitario Infanta Leonor

Madrid, 28031

Spain

Centro de Atención Integral La Corredoria

Oviedo, 33011

Spain

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, 37005

Spain

Complejo Asistencial de Zamora

Zamora, 49021

Spain

Keelung Chang Gung Memorial Hospital

Keelung, 204

Taiwan

Chung Shan Medical University Hospital

Taichung, 402

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Taipei Medical University Hospital

Taipei, 110

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Cheng Hsin General Hospital

Taipei, 112

Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333

Taiwan

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

The Maudsley Hospital

London, SE5 8AZ

United Kingdom

Clerkenwell Health - London - Welbeck Street

London, W1G 8DR

United Kingdom

Queen's Medical Centre, Nottingham University Hospitals

Nottingham, NG7 2UH

United Kingdom

Warneford Hospital

Oxford, OX3 7JX

United Kingdom

St Bartholomew's Medical Centre

Oxford, OX4 1XB

United Kingdom

Atlantic Medical

Penzance, TR18 3DX

United Kingdom

Woodstock Bower Surgery

Rotherham, S61 1AH

United Kingdom