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RECRUITING Phase 3 ClinicalTrials.gov

A Study of Brenipatide in Adult Participants With Major Depressive Disorder

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT07412756

Registry updated: 2026-10-05
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Description

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 four periods as follows: a screening period that will last approximately 1 month, a treatment period with a potential post treatment period that combined will last a minimum of 12 months, and the follow up period that will last approximately 2 months.

Interventions

  • Brenipatide (Drug)
    Administered SC
  • Placebo (Drug)
    Administered SC

Eligibility criteria

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

Conditions

Depressive Disorder, Major

Locations

  • 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
  • K2 Medical Research - Foxborough — Foxborough, 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
  • Penn Medicine: University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
  • Suburban Research Associates — West Chester, Pennsylvania, 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
  • 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
  • Toowoomba Hospital — Toowoomba, 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
  • Hamilton Medical Research Group — Hamilton, Canada
  • Kelowna Health and Memory Centre — Kelowna, 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
  • Chaohu Hospital of Anhui Medical University — Chaohu, 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
  • Zhenjiang Mental Health Center — Zhenjiang, China
  • Zhumadian Psychiatric Hospital — Zhumadian, China
  • Universitätsklinikum Aachen — Aachen, Germany
  • FutureMeds Berlin — 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
  • 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
  • Private Practice - Dr. Małgorzata Wojtanowska-Bogacka — Poznan, Poland
  • Centrum Medyczne Euromedis — Szczecin, 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
  • 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, 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record