NCT07775300RecruitingPhase 3
A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Major Depressive Disorder (RENEW-MDD- 2)
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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 and a post- treatment period that combined will last a minimum of 12 months, and the safety 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 14 Aug 2026
- Start date
- 14 Aug 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Depression
- NCT number
- NCT07775300
- EU CT number
- 2025-522310-24-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1000
- From 14 Aug 2026 to the primary completion date, 31 Dec 2028
- 170 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Are actively suicidal or deemed a significant risk for suicide
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (170)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ramsay Clinic New Farm Coordinator of this site? Confirm its status | Brisbane | Australia | Not yet recruiting |
| Paratus Clinical Research Canberra Coordinator of this site? Confirm its status | Bruce | Australia | Not yet recruiting |
| NeuroCentrix Coordinator of this site? Confirm its status | Carlton | Australia | Not yet recruiting |
| Lyell McEwin Hospital Coordinator of this site? Confirm its status | Elizabeth Vale | Australia | Not yet recruiting |
| Barwon Health Coordinator of this site? Confirm its status | Geelong | Australia | Not yet recruiting |
| Ramsay Clinic Albert Road Coordinator of this site? Confirm its status | Melbourne | Australia | Not yet recruiting |
| Multidisciplinary Alfred Psychiatry Research Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Not yet recruiting |
| Toowoomba Hospital Coordinator of this site? Confirm its status | Toowoomba | Australia | Not yet recruiting |
| Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Not yet recruiting |
| Instituto de Pesquisa Clínica de Campinas Coordinator of this site? Confirm its status | Campinas | Brazil | Not yet recruiting |
| Cline Research Center Coordinator of this site? Confirm its status | Curitiba | Brazil | Not yet recruiting |
| Clinica Neurologica Coordinator of this site? Confirm its status | Joinville | Brazil | Not yet recruiting |
| Instituto Mederi de Pesquisa e Saude Coordinator of this site? Confirm its status | Passo Fundo | Brazil | Not yet recruiting |
| Hospital das Clínicas - UFPE Coordinator of this site? Confirm its status | Recife | Brazil | Not yet recruiting |
| Centro Multidisciplinar de Estudos Clinicos Coordinator of this site? Confirm its status | São Bernardo do Campo | Brazil | Not yet recruiting |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Not yet recruiting |
| PSEG Centro de Pesquisa Clinica Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| CEPIC - Centro Paulista de Investigação Clínica Coordinator of this site? Confirm its status | São Paulo | Brazil | Not yet recruiting |
| CEDOES Coordinator of this site? Confirm its status | Vitória | Brazil | Not yet recruiting |
| Integral Pesquisa e Ensino Coordinator of this site? Confirm its status | Votuporanga | Brazil | Not yet recruiting |
| CaRe Clinic Coordinator of this site? Confirm its status | Calgary | Canada | Not yet recruiting |
| Kelowna Health and Memory Centre Coordinator of this site? Confirm its status | Kelowna | Canada | Not yet recruiting |
| Providence Care Coordinator of this site? Confirm its status | Kingston | Canada | Not yet recruiting |
| Alpha Recherche Clinique - Lévis Coordinator of this site? Confirm its status | Lévis | Canada | Not yet recruiting |
| AMNDX Coordinator of this site? Confirm its status | Markham | Canada | Not yet recruiting |
| Malton Medical Group Coordinator of this site? Confirm its status | Mississauga | Canada | Not yet recruiting |
| Alpha Recherche Clinique Coordinator of this site? Confirm its status | Québec | Canada | Not yet recruiting |
| Richmond Clinical Trials Coordinator of this site? Confirm its status | Richmond | Canada | Not yet recruiting |
| Research, Innovation, Science and Excellence (RISE) Institute Coordinator of this site? Confirm its status | Toronto | Canada | Not yet recruiting |
| Beijing Anding Hospital - Affiliated Capital University of Medical Science Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Chaohu Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Chaohu | China | Recruiting |
| Shandong Mental Health Center Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Linfen Central Hospital Coordinator of this site? Confirm its status | Linfen | China | Recruiting |
| Shanghai Tongji Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Suzhou Guangji Hospital Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Tianjin Anding Hospital Coordinator of this site? Confirm its status | Tianjin | China | Not yet recruiting |
| The Affiliated Kangning Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| Wuhu Hospital of Beijing Anding hospital Coordinator of this site? Confirm its status | Wuhu | China | Recruiting |
| Zhenjiang mental health center Coordinator of this site? Confirm its status | Zhenjiang | China | Recruiting |
| FutureMeds GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Pharmakologisches Studienzentrum Chemnitz GmbH Coordinator of this site? Confirm its status | Chemnitz | Germany | Recruiting |
| Klinische Forschung Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Universitaet Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbH Coordinator of this site? Confirm its status | Schwerin | Germany | Recruiting |
| Hestia Palau S.L. Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| EAP Osona Sud - Alt Congost S.L.P Coordinator of this site? Confirm its status | Centelles | Spain | Recruiting |
| Hospital Universitario Infanta Leonor Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Complejo Asistencial Universitario de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Parc Sanitari Sant Joan de Déu Coordinator of this site? Confirm its status | Sant Boi de Llobregat | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Provincial de Zamora Coordinator of this site? Confirm its status | Zamora | Spain | Recruiting |
| Servicio de Salud Mental del Área IV CSM La Corredoría Oviedo Coordinator of this site? Confirm its status | - | Spain | Recruiting |
| Bodmin Community Hospital Coordinator of this site? Confirm its status | Bodmin | United Kingdom | Not yet recruiting |
| Edinburgh Royal Infirmary Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Not yet recruiting |
| Devon Partnership Trust Coordinator of this site? Confirm its status | Exeter | United Kingdom | Not yet recruiting |
| Queen Elizabeth University Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Not yet recruiting |
| Avrin - Liverpool Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Not yet recruiting |
| Neuroclnx Coordinator of this site? Confirm its status | Motherwell | United Kingdom | Recruiting |
| St Bartholomew's Medical Centre Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
| Atlantic Medical Coordinator of this site? Confirm its status | Penzance | United Kingdom | Not yet recruiting |
| Ascend Clinical Research Coordinator of this site? Confirm its status | Reading | United Kingdom | Recruiting |
| Woodstock Bower Surgery Coordinator of this site? Confirm its status | Rotherham | United Kingdom | Recruiting |
| Argolida General Hospital Coordinator of this site? Confirm its status | Argos-Mykines | Greece | Not yet recruiting |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" Coordinator of this site? Confirm its status | Chaïdári | Greece | Not yet recruiting |
| Multidisciplinary Mental Health Hospital of Attiki Coordinator of this site? Confirm its status | Chaidari, Athens | Greece | Not yet recruiting |
| General Hospital Of Thessaloniki Papageorgiou Coordinator of this site? Confirm its status | Efkarpia | Greece | Not yet recruiting |
| University General Hospital of Ioannina Coordinator of this site? Confirm its status | Ioannina | Greece | Not yet recruiting |
| Sismanogleio General Hospital Coordinator of this site? Confirm its status | Maroussi | Greece | Not yet recruiting |
| Pan-Arcadian General Hospital Of Tripoli Evangelistria Coordinator of this site? Confirm its status | Tripolis | Greece | Not yet recruiting |
| Kuramitsu Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Not yet recruiting |
| Medical corporation Shinseikai Kaku Mental Clinic Coordinator of this site? Confirm its status | Fukuoka | Japan | Not yet recruiting |
| UNB Sumiyoshi Jinjamae Clinic Coordinator of this site? Confirm its status | Hakata-Ku | Japan | Not yet recruiting |
| Hinotoyoda Cocoro Clinic Coordinator of this site? Confirm its status | Hino | Japan | Not yet recruiting |
| Rainbow and Sea Hospital Coordinator of this site? Confirm its status | Karatsu | Japan | Not yet recruiting |
| Kishiro Mental Clinic Coordinator of this site? Confirm its status | Kawasaki | Japan | Not yet recruiting |
| Hiiragi Kokoro Clinic - Kokurain Coordinator of this site? Confirm its status | Kitakyushu | Japan | Not yet recruiting |
| Juntendo Koshigaya Hospital Coordinator of this site? Confirm its status | Koshigaya | Japan | Not yet recruiting |
| Monzen-nakacho Mental Clinic Coordinator of this site? Confirm its status | Kōtō City | Japan | Not yet recruiting |
| National Hospital Organization Shimofusa Psychiatric Medical Center Coordinator of this site? Confirm its status | MIdori-ku, Chiba-shi | Japan | Not yet recruiting |
| Tokyo Nakano Mental Clinic Coordinator of this site? Confirm its status | Nakano City | Japan | Not yet recruiting |
| Watanabe Clinic Coordinator of this site? Confirm its status | Osaka | Japan | Not yet recruiting |
| Yutaka Clinic Coordinator of this site? Confirm its status | Sagamihara | Japan | Not yet recruiting |
| Kitasato University Hospital Coordinator of this site? Confirm its status | Sagamihara | Japan | Not yet recruiting |
| Maynds Tower Mental Clinic Coordinator of this site? Confirm its status | Shibuya-ku | Japan | Not yet recruiting |
| Etoh Mentalclinic Meguro Coordinator of this site? Confirm its status | Shinagawa City | Japan | Not yet recruiting |
| Tokumoto Komorebi Clinic Coordinator of this site? Confirm its status | Suita | Japan | Not yet recruiting |
| Sangenjaya Nakamura Mental Clinic Coordinator of this site? Confirm its status | Tokyo | Japan | Not yet recruiting |
| Ikebukuro Olive Mental Clinic Coordinator of this site? Confirm its status | Toshima City | Japan | Not yet recruiting |
| Miki Mental Clinic Coordinator of this site? Confirm its status | Yokohama | Japan | Not yet recruiting |
| Yokohama Mental Clinic Totsuka Coordinator of this site? Confirm its status | Yokohama | Japan | Not yet recruiting |
| Korea University Ansan Hospital Coordinator of this site? Confirm its status | Ansan-si | South Korea | Not yet recruiting |
| Chonnam National University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Not yet recruiting |
| Jeju National University Hospital Coordinator of this site? Confirm its status | Jeju City | South Korea | Not yet recruiting |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Konkuk University Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Scientia Investigacion Clinica S.C. Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Not yet recruiting |
| Scientia Investigacion Clinica Tj Coordinator of this site? Confirm its status | Ciudad de Tijuana | Mexico | Not yet recruiting |
| Investigación Clínica Cuernavaca, S.C. Coordinator of this site? Confirm its status | Cuernavaca | Mexico | Not yet recruiting |
| Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C. Coordinator of this site? Confirm its status | Culiacán | Mexico | Not yet recruiting |
| Medical Care and Research Sa de Cv Coordinator of this site? Confirm its status | Mérida | Mexico | Not yet recruiting |
| Human Science Research Trials Coordinator of this site? Confirm its status | Mexico City | Mexico | Not yet recruiting |
| RM Pharma Specialists Coordinator of this site? Confirm its status | Mexico City | Mexico | Not yet recruiting |
| Ketamine Clinic México Coordinator of this site? Confirm its status | Mexico City | Mexico | Not yet recruiting |
| FAICIC S. de R.L. de C.V. Coordinator of this site? Confirm its status | Veracruz | Mexico | Not yet recruiting |
| Núcleo de Investigación Médica Sur de Guadalajara Coordinator of this site? Confirm its status | Zapopan | Mexico | Not yet recruiting |
| Revit Sp. z o.o. Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
| MentalMEDIC Grzegorz Giemza, Gliwickie Centrum Psychiatrii i Psychoterapii Coordinator of this site? Confirm its status | Bielsko-Biała | Poland | Recruiting |
| In- Vivo Sp. z o. o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Diamond Clinic Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Penta Hospitals Badania Kliniczne sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| NZOP Mentis Coordinator of this site? Confirm its status | Leszno | Poland | Recruiting |
| Santa SP. z o.o Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Nowy Szpital W Olkuszu Sp. z o.o. Coordinator of this site? Confirm its status | Olkusz | Poland | Recruiting |
| Praktyka Lekarska Małgorzata Wojtanowska-Bogacka Coordinator of this site? Confirm its status | Poznań | Poland | Recruiting |
| Ginemedica Sp. z o.o. Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Clinhouse Sp. z o.o. Coordinator of this site? Confirm its status | Zabrze | Poland | Recruiting |
| Barbara Diaz Hernandez MD Research Inc Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Not yet recruiting |
| INSPIRA Clinical Research Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Recruiting |
| Instituto De Neurologia Dra. Ivonne Fraga Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Not yet recruiting |
| Keelung Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Keelung | Taiwan | Not yet recruiting |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Not yet recruiting |
| Chung Shan Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Not yet recruiting |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Not yet recruiting |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Not yet recruiting |
| Cheng Hsin General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Not yet recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Not yet recruiting |
| Chang Gung Medical Foundation-Linkou Branch Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Not yet recruiting |
| JEM Research Institute Coordinator of this site? Confirm its status | Atlantis | United States | Recruiting |
| FutureSearch Trials of Neurology Coordinator of this site? Confirm its status | Austin | United States | Not yet recruiting |
| Pharmasite Research, Inc. Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Gadolin Research Coordinator of this site? Confirm its status | Beaumont | United States | Recruiting |
| Northwest Clinical Research Center Coordinator of this site? Confirm its status | Bellevue | United States | Recruiting |
| University of Alabama at Birmingham School of Medicine Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Adams Clinical Boston Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Key Clinical Research Coordinator of this site? Confirm its status | Bradenton | United States | Recruiting |
| Bradenton Research Center, Inc. Coordinator of this site? Confirm its status | Bradenton | United States | Recruiting |
| Charter Research Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| CenExel iResearch, LLC Coordinator of this site? Confirm its status | Decatur | United States | Not yet recruiting |
| Adams Clinical Dallas Coordinator of this site? Confirm its status | DeSoto | United States | Recruiting |
| The University of Texas Rio Grande Valley Coordinator of this site? Confirm its status | Harlingen | United States | Not yet recruiting |
| NextPhase Research Florida - Hollywood Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| Irvine Clinical Research Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| Olympus Clinical Research Coordinator of this site? Confirm its status | Katy | United States | Recruiting |
| Healthy Brain Clinic Coordinator of this site? Confirm its status | Long Beach | United States | Not yet recruiting |
| Diverse Clinical Research Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Quantix Research - Miami - Southwest 72nd Street Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Miami Jewish Health Coordinator of this site? Confirm its status | Miami | United States | Not yet recruiting |
| CLA Research Coordinator of this site? Confirm its status | Naples | United States | Recruiting |
| Oakland Clinical Coordinator of this site? Confirm its status | Oakland | United States | Recruiting |
| Be Well Clinical Studies - Omaha Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Adams Clinical Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Penn Medicine: University of Pennsylvania Health System Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| NoesisPharma, LLC Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Boeson Research - Provo Coordinator of this site? Confirm its status | Provo | United States | Recruiting |
| AGILE Clinical Research Trials, LLC Coordinator of this site? Confirm its status | Sandy Springs | United States | Recruiting |
| Adams Clinical Bronx Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Coordinator of this site? Confirm its status | Troy | United States | Recruiting |
| Concierge Clinical Trials Coordinator of this site? Confirm its status | Valley Village | United States | Recruiting |
| Adams Clinical Watertown Coordinator of this site? Confirm its status | Watertown | United States | Recruiting |
| Suburban Research Associates Coordinator of this site? Confirm its status | West Chester | United States | Recruiting |
| Health Synergy Clinical Research Coordinator of this site? Confirm its status | West Palm Beach | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.