NCT07412756RecruitingPhase 3
A Study of Brenipatide 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 1)
Source: ClinicalTrials.gov · Last updated 5 Oct 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 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 6 Feb 2026
- Start date
- 9 Feb 2026
- Primary completion date
- 29 Feb 2028
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Depression
- NCT number
- NCT07412756
- EU CT number
- 2025-522308-25-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1000
- From 9 Feb 2026 to the primary completion date, 29 Feb 2028
- 180 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 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 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (180)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NeuroCentrix Coordinator of this site? Confirm its status | Carlton | Australia | 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 | Recruiting |
| Paratus Clinical Research - Melbourne Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Multidisciplinary Alfred Psychiatry Research Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Toowoomba Hospital Coordinator of this site? Confirm its status | Toowoomba | Australia | Recruiting |
| Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Recruiting |
| Hospital das Clinicas da UFMG Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Not yet recruiting |
| Trial Tech Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| Centro de Pesquisa Clínica de Marília - CPCLIM Coordinator of this site? Confirm its status | Marília | Brazil | Recruiting |
| Clinilive Coordinator of this site? Confirm its status | Maringá | Brazil | Recruiting |
| Hospital Universitário Onofre Lopes Coordinator of this site? Confirm its status | Natal | Brazil | Recruiting |
| Ruschel Medicina e Pesquisa Clínica Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| Facili - Centro Integrado de Psiquiatria Coordinator of this site? Confirm its status | São Bernardo do Campo | Brazil | Recruiting |
| CPCLIN Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| BR Trials-Ensaios Clinicos e Consultoria Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| CPQuali Pesquisa Clínica Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos Coordinator of this site? Confirm its status | Valinhos | Brazil | Recruiting |
| Heritage Medical Research Clinic Coordinator of this site? Confirm its status | Calgary | Canada | Not yet recruiting |
| Hamilton Medical Research Group Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| Kelowna Health and Memory Centre Coordinator of this site? Confirm its status | Kelowna | Canada | Not yet recruiting |
| Alpha Recherche Clinique - Lévis Coordinator of this site? Confirm its status | Lévis | Canada | Recruiting |
| Genge Partners Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Dar Clinical Research - Ottawa Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Alpha Recherche Clinique Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| Centre de Recherche Saint-Louis inc. Coordinator of this site? Confirm its status | Québec | Canada | Not yet recruiting |
| Richmond Clinical Trials Coordinator of this site? Confirm its status | Richmond | Canada | Recruiting |
| Bluewater Clinical Research Group Inc. Coordinator of this site? Confirm its status | Sarnia | Canada | Recruiting |
| Diex Recherche Sherbrooke Coordinator of this site? Confirm its status | Sherbrooke | Canada | Suspended |
| Centre for Neurology Studies Coordinator of this site? Confirm its status | Surrey | Canada | Not yet recruiting |
| Maple Leaf Research Coordinator of this site? Confirm its status | Toronto | Canada | Suspended |
| Beijing Anding Hospital - Affiliated Capital University of Medical Science Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Huilongguan Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The Second People's Hospital of Hunan Province Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Chaohu Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Chaohu | China | Not yet recruiting |
| The Fourth People's Hospital of Chengdu Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Guangzhou Brain Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Peking University Sixth Hospital Coordinator of this site? Confirm its status | Haidian District | China | Recruiting |
| Hefei No.4 People's Hospital Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| 3rd People's Hospital of Huzhou Coordinator of this site? Confirm its status | Huzhou | China | Recruiting |
| Shandong Daizhuang Hospital Coordinator of this site? Confirm its status | Jining | China | Recruiting |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| The Affilicated Kangning Hospital of Ningbo University Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
| Shanghai Mental Health Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| The First Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | 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 | Recruiting |
| Renmin Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Wuxi Mental Health Center Coordinator of this site? Confirm its status | Wuxi | China | Recruiting |
| Xi'an Mental Health Center Coordinator of this site? Confirm its status | Xi’an | China | Recruiting |
| Xianyang Hospital of Yan'an University Coordinator of this site? Confirm its status | Xianyang | China | Recruiting |
| Zhenjiang mental health center Coordinator of this site? Confirm its status | Zhenjiang | China | Not yet recruiting |
| Zhumadian Psychiatric Hospital Coordinator of this site? Confirm its status | Zhumadian | China | Recruiting |
| Universitätsklinikum Aachen Coordinator of this site? Confirm its status | Aachen | Germany | Recruiting |
| FutureMeds Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Neurozentrum Bielefeld Coordinator of this site? Confirm its status | Bielefeld | Germany | Recruiting |
| Pharmakologisches Studienzentrum Chemnitz Coordinator of this site? Confirm its status | Chemnitz | Germany | Recruiting |
| Universitätsmedizin Johannes Gutenberg Universität Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Not yet recruiting |
| ISPG - Institut für Studien zur Psychischen Gesundheit Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
| Somni bene Coordinator of this site? Confirm its status | Schwerin | Germany | Recruiting |
| ZNS Siegen Coordinator of this site? Confirm its status | Siegen | Germany | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Institucion Hosp Hestia Palau Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Parc de Salut Mar - Hospital del Mar 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 de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Infanta Leonor Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Centro de Atención Integral La Corredoria Coordinator of this site? Confirm its status | Oviedo | Spain | Not yet recruiting |
| Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Complejo Asistencial de Zamora Coordinator of this site? Confirm its status | Zamora | Spain | Recruiting |
| Edinburgh Royal Infirmary Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Recruiting |
| Devon Partnership Trust Coordinator of this site? Confirm its status | Exeter | United Kingdom | Recruiting |
| Queen Elizabeth University Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| Clerkenwell Health - London - Welbeck Street Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Maudsley Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Queen's Medical Centre, Nottingham University Hospitals Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Recruiting |
| Warneford Hospital Coordinator of this site? Confirm its status | Oxford | 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 | 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 | Greece | Recruiting |
| Aiginiteio University Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Multidisciplinary Mental Health Hospital of Attiki Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Attikon General University Hospital Coordinator of this site? Confirm its status | Chaïdári | Greece | Recruiting |
| Multidisciplinary Mental Health Hospital of Thessaloniki Coordinator of this site? Confirm its status | Stavroupoli | Greece | Recruiting |
| Papageorgiou General Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| General Hospital of Tripoli Panarkadiko Evangelistria Coordinator of this site? Confirm its status | Tripoli | Greece | Recruiting |
| Abe Clinic - Arakawa Coordinator of this site? Confirm its status | Arakawa City | Japan | Recruiting |
| Uematsu Mental Clinic Coordinator of this site? Confirm its status | Chikugo | Japan | Recruiting |
| Jimbocho Mental Clinic Coordinator of this site? Confirm its status | Chiyoda City | Japan | Recruiting |
| Kokorono Clinic Hirao Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| Fukuoka University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| Horikoshi Mental Somatic Clinic Coordinator of this site? Confirm its status | Fukushima | Japan | Recruiting |
| University of the Ryukyus Hospital Coordinator of this site? Confirm its status | Ginowan | Japan | Recruiting |
| Fujimidai Hospital Coordinator of this site? Confirm its status | Hiratsuka | Japan | Recruiting |
| Rainbow and Sea Hospital Coordinator of this site? Confirm its status | Karatsu | Japan | Recruiting |
| Kishiro Mental Clinic Coordinator of this site? Confirm its status | Kawasaki | Japan | Recruiting |
| Monzen-nakacho Mental Clinic Coordinator of this site? Confirm its status | Kōtō City | Japan | Recruiting |
| Suizenji Life Clinic Coordinator of this site? Confirm its status | Kumamoto | Japan | Recruiting |
| Yuge Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Recruiting |
| Kure Medical Center Coordinator of this site? Confirm its status | Kure | Japan | Recruiting |
| Hirota Clinic Coordinator of this site? Confirm its status | Kurume | Japan | Recruiting |
| Senzoku Psychosomatic Medicine Clinic Coordinator of this site? Confirm its status | Meguro-ku | Japan | Recruiting |
| Arata Clinic Coordinator of this site? Confirm its status | Nagasaki | Japan | Recruiting |
| Yutaka Clinic Coordinator of this site? Confirm its status | Sagamihara | Japan | Recruiting |
| Sangenjaya Shinkeika Shinryonaika Clinic Coordinator of this site? Confirm its status | Setagaya City | Japan | Recruiting |
| Maynds Tower Mental Clinic Coordinator of this site? Confirm its status | Shibuya-ku | Japan | Recruiting |
| Nanko Kokorono Clinic Coordinator of this site? Confirm its status | Shirakawa | Japan | Recruiting |
| Sakurazaka Clinic SophyAnce Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Yamagata Sakuracho Hospital Coordinator of this site? Confirm its status | Yamagata | Japan | Recruiting |
| Miki Mental Clinic Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| Shioiri Mental Clinic Coordinator of this site? Confirm its status | Yokosuka | Japan | Recruiting |
| Korea University Ansan Hospital Coordinator of this site? Confirm its status | Ansan-si | South Korea | Recruiting |
| Chonnam National University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Recruiting |
| Jeju National University Hospital Coordinator of this site? Confirm its status | Jeju City | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Konkuk University Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Scientia Investigacion Clinica S.C. Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Not yet recruiting |
| Clinica de Investigacion en Reumatologia y Obesidad S. C. Coordinator of this site? Confirm its status | Guadalajara | Mexico | Not yet recruiting |
| B&B Investigaciones Medicas S.C. Coordinator of this site? Confirm its status | Mazatlán | Mexico | Not yet recruiting |
| Medical Care and Research Sa de Cv Coordinator of this site? Confirm its status | Mérida | Mexico | Not yet recruiting |
| Ketamine Clinic México Coordinator of this site? Confirm its status | Mexico City | Mexico | Not yet recruiting |
| GabiPros Coordinator of this site? Confirm its status | Mexico City | Mexico | Not yet recruiting |
| Centro de Investigacion Clinica Chapultepec Coordinator of this site? Confirm its status | Morelia | Mexico | Not yet recruiting |
| Arké SMO S.A de C.V Coordinator of this site? Confirm its status | Veracruz | Mexico | Not yet recruiting |
| Podlaskie Centrum Psychogeriatrii Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
| MentalMEDIC Coordinator of this site? Confirm its status | Bielsko-Biala | Poland | Not yet recruiting |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Not yet recruiting |
| Diamond Clinic Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| NZOZ Psychiatrycznej Mentis Coordinator of this site? Confirm its status | Leszno | Poland | Not yet recruiting |
| Private Practice - Dr. Małgorzata Wojtanowska-Bogacka Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Centrum Medyczne Euromedis Coordinator of this site? Confirm its status | Szczecin | Poland | Not yet recruiting |
| Centrum Medyczne Ginemedica Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| ClinHouse Centrum Medyczne Coordinator of this site? Confirm its status | Zabrze | Poland | Not yet recruiting |
| SCB Research Center Coordinator of this site? Confirm its status | Bayamón | Puerto Rico | Recruiting |
| Keelung Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Keelung | Taiwan | Recruiting |
| Chung Shan Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| Taipei Medical University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Cheng Hsin General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Chang Gung Medical Foundation-Linkou Branch Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Recruiting |
| Pharmasite Research, Inc. Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Northwest Clinical Research Center Coordinator of this site? Confirm its status | Bellevue | United States | Recruiting |
| Adams Clinical Boston Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Alpine Research Organization Coordinator of this site? Confirm its status | Clinton | United States | Recruiting |
| CenExel iResearch, LLC Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| Adams Clinical Dallas Coordinator of this site? Confirm its status | DeSoto | United States | Recruiting |
| Re:Cognition Health Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Re:Cognition Health - Fort Worth Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| K2 Medical Research - Foxborough Coordinator of this site? Confirm its status | Foxborough | United States | Recruiting |
| Encore Medical Research Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| Indiana University Health Neuroscience Center Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Vector Clinical Trials Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| K2 Medical Research - Maitland Coordinator of this site? Confirm its status | Maitland | United States | Recruiting |
| Life Medical Research Group Corp Coordinator of this site? Confirm its status | Miami Gardens | United States | Recruiting |
| Floridian Clinical Research, LLC Coordinator of this site? Confirm its status | Miami Lakes | United States | Recruiting |
| Accellacare - Moorpark Coordinator of this site? Confirm its status | Moorpark | United States | Recruiting |
| CLA Research Coordinator of this site? Confirm its status | Naples | United States | Recruiting |
| Yale University School Of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
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| ATP Clinical Research Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
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| Charter Research - Orlando Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Penn Medicine: University of Pennsylvania Health System Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Summit Headlands Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Consano Clinical Research, LLC Coordinator of this site? Confirm its status | Shavano Park | United States | Recruiting |
| Circle Clinical Research Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
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This page is information, not medical advice. Discuss any trial with your doctor.