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NCT07410507RecruitingPhase 2

A Study of Brenipatide in Adult Participants With Schizophrenia

A Phase 2 Multicenter, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Adult Participants With Schizophrenia (RENEW-Scz-1)

Source: ClinicalTrials.gov · Last updated 7 Oct 2026

Brief summary (registry, in English)

The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC for treatment of schizophrenia. The trial is divided into three periods as follows: Screening period will last approximately 1 month, treatment period will last a maximum of 12 months, and the follow up period will last approximately 2 months. The length of time of your study participation may last up to approximately 15 months.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
450 (estimated)
First submitted
6 Feb 2026
Start date
10 Feb 2026
Primary completion date
Nov 2027
Lead sponsor
Eli Lilly and Company
NCT number
NCT07410507

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 450
  • From 10 Feb 2026 to the primary completion date, Nov 2027
  • 101 sites in 7 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

  • Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study

Other illness

  • Have lifetime history of bipolar disorder, borderline personality disorder, or any eating disorder
  • Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
  • Have type 1 diabetes, or history of ketoacidosis or hyperosmolar state or coma

Other

  • Are actively suicidal or deemed to be a significant risk for suicide

Who the study is looking for

  • Meet the diagnostic criteria of schizophrenia
  • Are on a stable standard of care medication regimen for schizophrenia
  • If the duration of illness is \>6 years, participant has experienced at least one relapse of schizophrenia in last 3 years
  • Have at least 1 reliable study partner (for example, a family member, social worker, caseworker, residential facility staff, or nurse)
  • 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 study intervention as directed,
    • maintain electronic or paper study diaries, as applicable, and
    • complete the required questionnaires

Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (101)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro Neurobiológico y de Estrés Traumático (CENydET)
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Buenos AiresArgentinaRecruiting
Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)
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Buenos AiresArgentinaRecruiting
Instituto Nacional de Psicopatología (INAPsi)- FunDaMos
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Buenos AiresArgentinaRecruiting
Fundacion CENIT para la Investigacion en Neurociencias
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CabaArgentinaNot yet recruiting
Sanatorio Morra S.A.
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CórdobaArgentinaRecruiting
Centro Médico Luquez
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CórdobaArgentinaRecruiting
Instituto Kremer
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CórdobaArgentinaRecruiting
CEN Centro Especializado en Neurociencias
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CórdobaArgentinaRecruiting
INSA Instituto de Neurociencia San Agustin
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La PlataArgentinaRecruiting
Global Psy Asociación Civil
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La PlataArgentinaRecruiting
Resolution Psychopharmacology Research Institute
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MendozaArgentinaRecruiting
Centro de Investigacion y Asistencia en Psiquiatria (CIAP)
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RosarioArgentinaRecruiting
Fundacion Estudios Clinicos
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RosarioArgentinaRecruiting
Hospital das Clinicas da UFMG
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Belo HorizonteBrazilRecruiting
Chronos Pesquisa Clínica
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BrasíliaBrazilRecruiting
Instituto de Pesquisa Clínica de Campinas
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CampinasBrazilRecruiting
Trial Tech
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CuritibaBrazilRecruiting
Clinilive
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MaringáBrazilRecruiting
Instituto Atena de Pesquisa Clínica
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NatalBrazilRecruiting
Ruschel Medicina e Pesquisa Clínica
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Rio de JaneiroBrazilRecruiting
Instituto Apice
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SalvadorBrazilRecruiting
CPQuali Pesquisa Clínica
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São PauloBrazilRecruiting
PSEG Centro de Pesquisa Clinica
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São PauloBrazilRecruiting
Clinica Viver - Centro de Desospitalizacao Humana
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São PauloBrazilRecruiting
The Second Xiangya Hospital of Central South University
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ChangshaChinaRecruiting
The Fourth People's Hospital of Chengdu
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ChengduChinaRecruiting
The Seventh People's Hospital of Hangzhou
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HangzhouChinaRecruiting
Suzhou Guangji Hospital
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SuzhouChinaRecruiting
Tianjin Anding Hospital
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TianjinChinaRecruiting
Wuhu Hospital of Beijing Anding hospital
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WuhuChinaRecruiting
Xi'an Mental Health Center
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Xi’anChinaRecruiting
Zhumadian Psychiatric Hospital
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ZhumadianChinaRecruiting
All India Institute of Medical Sciences (AIIMS) - Bhopal
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BhopalIndiaRecruiting
Galaxy Superspeciality Hospital
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Chhatrapati SambhajinagarIndiaRecruiting
Dharwad Institute Of Mental Health And Neurosciences
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DharwadIndiaRecruiting
Calida Rehab - Karjat
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KarjatIndiaRecruiting
Shree Mahalaxmi DIATONE Institute
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KolhāpurIndiaRecruiting
Career Institute of Medical Sciences and Hospital - Lucknow
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LucknowIndiaRecruiting
Dr Ram Manohar Lohia Institute of Medical Sciences
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LucknowIndiaRecruiting
D.Y. Patil Hospital
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Navi MumbaiIndiaRecruiting
Lifepoint Multispeciality Hospital
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PuneIndiaRecruiting
Medipoint Hospitals Pvt. Ltd.
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PuneIndiaRecruiting
Sowmanasya Hospital and Institute of Psychiatry
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TiruchirappalliIndiaRecruiting
Uematsu Mental Clinic
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ChikugoJapanRecruiting
Horikoshi Mental Somatic Clinic
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FukushimaJapanRecruiting
Seinan Hospital
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HachinoheJapanNot yet recruiting
Fujimidai Hospital
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HiratsukaJapanRecruiting
Rainbow and Sea Hospital
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KaratsuJapanRecruiting
National Center of Neurology and Psychiatry
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KodairaJapanRecruiting
Yuge Hospital
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KumamotoJapanRecruiting
Hirota Clinic
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KurumeJapanRecruiting
Asuka Hospital
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MachidaJapanRecruiting
Arata Clinic
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NagasakiJapanRecruiting
Yutaka Clinic
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SagamiharaJapanRecruiting
Sho Midori Hospital
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SaitamaJapanRecruiting
Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi
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TokyoJapanRecruiting
Okehazama Hospital
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ToyoakeJapanRecruiting
Yamagata Sakuracho Hospital
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YamagataJapanRecruiting
Shioiri Mental Clinic
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YokosukaJapanRecruiting
Changhua Christian Hospital
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ChanghuaTaiwanRecruiting
Keelung Chang Gung Memorial Hospital
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KeelungTaiwanRecruiting
Chung Shan Medical University Hospital
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TaichungTaiwanRecruiting
National Cheng Kung University Hospital
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TainanTaiwanRecruiting
Taipei Medical University Hospital
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TaipeiTaiwanRecruiting
Taipei Veterans General Hospital
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TaipeiTaiwanRecruiting
Tri-Service General Hospital
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TaipeiTaiwanRecruiting
Taipei City Hospital - Songde Branch
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TaipeiTaiwanNot yet recruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
Chang Gung Medical Foundation-Linkou Branch
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TaoyuanTaiwanRecruiting
Atlanta Center for Medical Research
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AtlantaUnited StatesRecruiting
Augusta University
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AugustaUnited StatesRecruiting
Northwest Clinical Research Center
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BellevueUnited StatesRecruiting
Clinical Innovations, Inc. dba CITrials
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BellflowerUnited StatesRecruiting
McLean Hospital
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BelmontUnited StatesRecruiting
Re:Cognition Health - Chicago
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ChicagoUnited StatesRecruiting
Magno Medical Research Group
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Cooper CityUnited StatesRecruiting
Adams Clinical Dallas
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DeSotoUnited StatesRecruiting
University of Oregon
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EugeneUnited StatesRecruiting
Re:Cognition Health - Fort Worth
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Fort WorthUnited StatesRecruiting
CBH Health
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GaithersburgUnited StatesRecruiting
Collaborative NeuroScience Research , LLC
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Garden GroveUnited StatesRecruiting
Institute of Living
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HartfordUnited StatesRecruiting
NextPhase Research Florida - Hollywood
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HollywoodUnited StatesRecruiting
Insight Clinical Trials
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IndependenceUnited StatesRecruiting
Innovative Clinical Research
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LauderhillUnited StatesRecruiting
Pillar Clinical Research - Little Rock
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Little RockUnited StatesRecruiting
Accel Research Sites - Maitland Clinical Research Unit
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MaitlandUnited StatesRecruiting
Wellness Research Center
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MiamiUnited StatesRecruiting
Vital Medical Research
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MiamiUnited StatesRecruiting
Catalina Research Institute, LLC
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MontclairUnited StatesRecruiting
CLA Research
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NaplesUnited StatesRecruiting
Yale University School Of Medicine
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New HavenUnited StatesRecruiting
Adams Clinical Harlem
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New YorkUnited StatesRecruiting
APG Research, LLC
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OrlandoUnited StatesRecruiting
Adams Clinical Philadelphia
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PhiladelphiaUnited StatesRecruiting
Stanford University School of Medicine
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StanfordUnited StatesRecruiting
Arch Clinical Trials
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St LouisUnited StatesRecruiting
Collaborative Neuroscience Research LLC
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TorranceUnited StatesRecruiting
Sunwise Clinical Research
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Walnut CreekUnited StatesRecruiting
Adams Clinical Watertown
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WatertownUnited StatesRecruiting
University of Massachusetts Chan Medical School
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WorcesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.