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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT07775300

Registry updated: 2026-10-07
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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 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.

Interventions

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

Eligibility criteria

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

Conditions

Depressive Disorder, Major

Locations

  • 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
  • CLA Research — Naples, Florida, United States
  • Health Synergy Clinical Research — West Palm Beach, Florida, United States
  • CenExel iResearch, LLC — Decatur, Georgia, 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
  • Adams Clinical Philadelphia — Philadelphia, Pennsylvania, United States
  • Penn Medicine: University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
  • Suburban Research Associates — West Chester, Pennsylvania, United States
  • FutureSearch Trials of Neurology — Austin, Texas, 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
  • 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
  • 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
  • Chaohu Hospital of Anhui Medical University — 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 Berlin — 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
  • Medical corporation Shinseikai Kaku Mental Clinic — Fukuoka, Japan
  • Kuramitsu Hospital — Fukuoka, Japan
  • UNB Sumiyoshi Jinjamae Clinic — Hakata-Ku, Japan
  • Hinotoyoda Cocoro Clinic — Hino, Japan
  • Rainbow and Sea Hospital — Karatsu, Japan
  • Kishiro Mental Clinic — Kawasaki, Japan
  • Hiiragi Kokoro Clinic - Kokurain — Kitakyushu, Japan
  • Juntendo Koshigaya Hospital — Koshigaya, 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
  • Ikebukuro Olive Mental Clinic — Toshima City, Japan
  • Miki Mental Clinic — Yokohama, Japan
  • Yokohama Mental Clinic Totsuka — 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
  • Avrin - Liverpool — Liverpool, 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
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Official Source

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

View Official Record