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Could a new injection keep depression at bay for longer?

NCT ID NCT07775300

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether adding an experimental drug called brenipatide to standard depression treatment can delay the return of major depressive symptoms in adults with major depressive disorder. Participants receive either brenipatide or a placebo by injection, alongside their usual medication, for at least 12 months. The study measures how long it takes for depression symptoms to relapse and also tracks changes in mood, daily functioning, and body weight.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
brenipatide (an experimental drug given by injection)
What this could lead to
If successful, brenipatide could become an add-on treatment that helps people with major depression stay well longer between episodes.
What could go wrong
This is an early-phase test in a large group; the drug may not delay relapse better than placebo, and side effects or the need for self-injections could limit its use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder major depressive disorder mood disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depressive disorder, major

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    169 sites in 15 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AGILE Clinical Research Trials, LLC

    Sandy Springs, Georgia, 30328, United States

  • ALPHA Recherche Clinique

    Québec, G3K 2P8, Canada

  • AMNDX

    Markham, L3R 1A3, Canada

  • Adams Clinical Boston

    Boston, Massachusetts, 02116, United States

  • Adams Clinical Bronx

    The Bronx, New York, 10461, United States

  • Adams Clinical Dallas

    DeSoto, Texas, 75115, United States

  • Adams Clinical Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Adams Clinical Watertown

    Watertown, Massachusetts, 02472, United States

  • Alpha Recherche Clinique

    Québec, G2J 0C4, Canada

  • Alpha Recherche Clinique - Lévis

    Lévis, G6V 0C9, Canada

  • Anhui Medical University - Chaohu Hospital

    Chaohu, 238001, China

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan, 48098, United States

  • Argolida General Hospital

    Argos, 212 00, Greece

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Ascend Clinical Research

    Reading, RG7 8PA, United Kingdom

  • Atlantic Medical

    Penzance, TR18 3DX, United Kingdom

  • Attikon General University Hospital

    Chaïdári, 124 62, Greece

  • Barbara Diaz-Hernandez MD Research, Inc.

    San Juan, 00926, Puerto Rico

  • Barwon Health

    Geelong, 3220, Australia

  • Be Well Clinical Studies - Omaha

    Omaha, Nebraska, 68144, United States

  • Beijing Anding Hospital - Affiliated Capital University of Medical Science

    Beijing, 100088, China

  • Bodmin Community Hospital

    Bodmin, PL31 2QT, United Kingdom

  • Boeson Research - Provo

    Provo, Utah, 84604, United States

  • Bradenton Research Center, Inc.

    Bradenton, Florida, 34205, United States

  • CEDOES

    Vitória, 29055450, Brazil

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010, Brazil

  • CLA Research

    Naples, Florida, 34116, United States

  • CaRe Clinic

    Calgary, T2N 4L7, Canada

  • Centro Multidisciplinar de Estudos Clinicos

    São Bernardo do Campo, 09715-090, Brazil

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

    Culiacán, 80230, Mexico

  • Centro de Salud Mental (CSM) La Corredoria

    Oviedo, 33011, Spain

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

    Gdansk, 80-546, Poland

  • Centrum Medyczne Ginemedica

    Wroclaw, 50-414, Poland

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333, Taiwan

  • Charite Universitätsmedizin Berlin Campus Benjamin Franklin

    Berlin, 12203, Germany

  • Charter Research - Chicago

    Chicago, Illinois, 60618, United States

  • Charter Research - Orlando

    Orlando, Florida, 32803, United States

  • Cheng Hsin General Hospital

    Taipei, 112, Taiwan

  • Chonnam National University Hospital

    Gwangju, 61469, South Korea

  • Chung Shan Medical University Hospital

    Taichung, 402, Taiwan

  • Cline Research Center

    Curitiba, 80030-480, Brazil

  • Clinhouse Centrum Medyczne

    Zabrze, 41-807, Poland

  • Clínica Neurológica

    Joinville, 89202190, Brazil

  • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

    Seville, 41003, Spain

  • Complejo Asistencial de Zamora

    Zamora, 49021, Spain

  • Concierge Clinical Trials

    Valley Village, California, 91607, United States

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231, United States

  • De La Cruz Research Center, LLC

    Miami, Florida, 33184, United States

  • Devon Partnership Trust

    Exeter, EX2 5AF, United Kingdom

  • Diamond Clinic

    Krakow, 31-559, Poland

  • Diverse Clinical Research

    Miami, Florida, 33175, United States

  • EAP Osona Sud - Alt Congost S.L.P

    Centelles, 08540, Spain

  • Edinburgh Royal Infirmary

    Edinburgh, EH16 4SA, United Kingdom

  • Etoh Mentalclinic Meguro

    Shinagawa City, 141-0021, Japan

  • FAICIC S. de R.L. de C.V.

    Veracruz, 91900, Mexico

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, 15090000, Brazil

  • FutureMeds GmbH

    Berlin, 10629, Germany

  • Gadolin Research

    Beaumont, Texas, 77702, United States

  • General Hospital of Tripoli Panarkadiko Evangelistria

    Tripoli, 221 00, Greece

  • Health Synergy Clinical Research

    West Palm Beach, Florida, 33407, United States

  • Healthy Brain Clinic

    Long Beach, California, 90804, United States

  • Hiiragi Kokoro Clinic - Kokurain

    Kitakyushu, 802-0001, Japan

  • Hinotoyoda Cocoro Clinic

    Hino, 191-0062, Japan

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Universitario Infanta Leonor

    Madrid, 28031, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    Salamanca, 37005, Spain

  • Hospital das Clínicas - UFPE

    Recife, 50670-420, Brazil

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • Human Science Research Trials

    Mexico City, 14050, Mexico

  • IN VIVO

    Bydgoszcz, 85-048, Poland

  • INSPIRA Clinical Research

    San Juan, 00918, Puerto Rico

  • Institucion Hosp Hestia Palau

    Barcelona, 08025, Spain

  • Instituto De Neurologia Dra. Ivonne Fraga

    San Juan, 00918, Puerto Rico

  • Instituto Méderi de Pesquisa e Saúde

    Passo Fundo, 99010-120, Brazil

  • Instituto de Pesquisa clinica de Campinas

    Campinas, 13060-080, Brazil

  • Integral Pesquisa e Ensino

    Votuporanga, 15500-269, Brazil

  • Investigación Clínica Cuernavaca, S.C.

    Cuernavaca, 62448, Mexico

  • Irvine Clinical Research

    Irvine, California, 92614, United States

  • JEM Research Institute

    Atlantis, Florida, 33462, United States

  • Jeju National University Hospital

    Jeju City, 63241, South Korea

  • Keelung Chang Gung Memorial Hospital

    Keelung, 204, Taiwan

  • Kelowna Health and Memory Centre

    Kelowna, V1Y 5A8, Canada

  • Ketamine Clinic México

    Mexico City, 04100, Mexico

  • Key Clinical Research

    Bradenton, Florida, 34207, United States

  • Kishiro Mental Clinic

    Kawasaki, 214-0014, Japan

  • Kitasato University Hospital

    Sagamihara, 252-0375, Japan

  • Klinische Forschung Hamburg

    Hamburg, 20253, Germany

  • Konkuk University Medical Center

    Seoul, 05030, South Korea

  • Korea University Ansan Hospital

    Ansan-si, 15355, South Korea

  • Kuramitsu Hospital

    Fukuoka, 819-0037, Japan

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18103, United States

  • Linfen Central Hospital

    Linfen, 041000, China

  • Lyell McEwin Hospital

    Elizabeth Vale, 5112, Australia

  • Malton Medical Group

    Mississauga, L4T 4J2, Canada

  • Maynds Tower Mental Clinic

    Shibuya-ku, 151-0053, Japan

  • Medical Care and Research SA de CV

    Mérida, 97070, Mexico

  • Medical corporation Shinseikai Kaku Mental Clinic

    Fukuoka, 810-0022, Japan

  • MentalMEDIC

    Bielsko-Biala, 43-300, Poland

  • Miami Jewish health

    Miami, Florida, 33137, United States

  • Miki Mental Clinic

    Yokohama, 220-0023, Japan

  • Monzen-nakacho Mental Clinic

    Kōtō City, 135-0047, Japan

  • Multidisciplinary Alfred Psychiatry Research Centre

    Melbourne, 3004, Australia

  • Multidisciplinary Mental Health Hospital of Attiki

    Athens, 124 62, Greece

  • NZOZ Psychiatrycznej Mentis

    Leszno, 64-100, Poland

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Hospital Organization Shimofusa Psychiatric Medical Center

    MIdori-ku, Chiba-shi, 266-0007, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • NeuroCentrix

    Carlton, 3053, Australia

  • NeuroClnx

    Motherwell, ML1 4UF, United Kingdom

  • NextPhase Research Florida - Hollywood

    Hollywood, Florida, 33024, United States

  • NoesisPharma, LLC

    Phoenix, Arizona, 85028, United States

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Nowy Szpital w Olkuszu

    Olkusz, 32-300, Poland

  • Núcleo de Investigación Médica Sur de Guadalajara

    Zapopan, 45070, Mexico

  • Oakland Clinical

    Oakland, California, 94609, United States

  • Olympus Clinical Research

    Katy, Texas, 77450, United States

  • PSEG Centro de Pesquisa Clínica

    São Paulo, 04038-002, Brazil

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, 564 29, Greece

  • Paratus Clinical Research Canberra

    Bruce, 2617, Australia

  • Parc Sanitari Sant Joan de Déu

    Barcelona, 08029, Spain

  • Parc de Salut Mar - Hospital del Mar

    Barcelona, 08003, Spain

  • Peninsula Therapeutic & Research Group

    Frankston, 3199, Australia

  • Penn Medicine: University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104, United States

  • Pharmakologisches Studienzentrum Chemnitz

    Chemnitz, 09111, Germany

  • Pharmasite Research, Inc.

    Baltimore, Maryland, 21208, United States

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, 15-756, Poland

  • Private Practice - Dr. Małgorzata Wojtanowska-Bogacka

    Poznan, 60-192, Poland

  • Providence Care

    Kingston, K7L 4X3, Canada

  • Quantix Research - Miami - Southwest 72nd Street

    Miami, Florida, 33173, United States

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF, United Kingdom

  • RM Pharma Specialists

    Mexico City, 03100, Mexico

  • Rainbow and Sea Hospital

    Karatsu, 847-0031, Japan

  • Ramsay Clinic Albert Road

    Melbourne, 3004, Australia

  • Ramsay Clinic New Farm

    Brisbane, 4005, Australia

  • Research, Innovation, Science and Excellence (RISE) Institute

    Toronto, L5L 1W8, Canada

  • Richmond Clinical Trials

    Richmond, V6V 2L1, Canada

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sangenjaya Nakamura Mental Clinic

    Tokyo, 154-0004, Japan

  • Santa Familia PTG Lodz

    Lodz, 90-302, Poland

  • Scientia Investigacion Clinica S.C.

    Chihuahua City, 31207, Mexico

  • Scientia Investigacion Clinica Tj

    Ciudad de Tijuana, 22105, Mexico

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Shandong Mental Health Center

    Jinan, 250012, China

  • Shanghai Tongji Hospital

    Shanghai, 200065, China

  • Sismanogleio General Hospital of Attiki

    Athens, 151 26, Greece

  • Somni bene

    Schwerin, 19053, Germany

  • St Bartholomew's Medical Centre

    Oxford, OX4 1XB, United Kingdom

  • Suburban Research Associates

    Media, Pennsylvania, 19063, United States

  • Suzhou Guangji Hospital

    Suzhou, 215003, China

  • Taichung Veterans General Hospital

    Taichung, 407, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The Affiliated Kangning Hospital of Wenzhou Medical University

    Wenzhou, 325007, China

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

    Seoul, 06591, South Korea

  • The University of Texas Rio Grande Valley

    Harlingen, Texas, 78550, United States

  • Tianjin Anding Hospital

    Tianjin, 300022, China

  • Tokumoto Komorebi Clinic

    Suita, 564-0063, Japan

  • Tokyo Nakano Mental Clinic

    Nakano City, 164-0001, Japan

  • Toowoomba Hospital

    Toowoomba, 4350, Australia

  • University Hospital of Ioannina

    Ioannina, 455 00, Greece

  • University of Alabama at Birmingham - School of Medicine

    Birmingham, Alabama, 35294, United States

  • Universitätsklinikum Leipzig

    Leipzig, 04103, Germany

  • Watanabe Clinic

    Osaka, 541-0043, Japan

  • Westmead Hospital

    Westmead, 2145, Australia

  • Woodstock Bower Surgery

    Rotherham, S61 1AH, United Kingdom

  • Wuhu Hospital of Beijing Anding hospital

    Wuhu, 242407, China

  • Yutaka Clinic

    Sagamihara, 252-0303, Japan

  • Zhenjiang Mental Health Center

    Zhenjiang, 212000, China

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