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Recruiting Phase 2 NCT07410507

A Study of Brenipatide in Adult Participants With Schizophrenia

Phase 2 – studying effectiveness and dosage
Conditions: Schizophrenia

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Are actively suicidal or deemed to be a significant risk for suicide * 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
Interventions
Brenipatide
DRUG
Placebo
DRUG
Locations 102
Argentina (13)
Centro Neurobiológico y de Estrés Traumático (CENydET)
Buenos Aires
NOT_YET_RECRUITING
Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)
Buenos Aires
NOT_YET_RECRUITING
Instituto Nacional de Psicopatología (INAPsi)- FunDaMos
Buenos Aires
NOT_YET_RECRUITING
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires
NOT_YET_RECRUITING
CEN Centro Especializado en Neurociencias
Córdoba
NOT_YET_RECRUITING
Sanatorio Morra S.A.
Córdoba
NOT_YET_RECRUITING
Instituto Kremer
Córdoba
NOT_YET_RECRUITING
Centro Médico Luquez
Córdoba
NOT_YET_RECRUITING
INSA Instituto de Neurociencia San Agustin
La Plata
NOT_YET_RECRUITING
Global Psy Asociación Civil
La Plata
NOT_YET_RECRUITING
Resolution Psychopharmacology Research Institute
Mendoza
NOT_YET_RECRUITING
Centro de Investigación y Asistencia en Psiquiatría (CIAP)
Rosario
NOT_YET_RECRUITING
Fundacion Estudios Clinicos
Rosario
NOT_YET_RECRUITING
Brazil (11)
Hospital das Clínicas da UFMG
Belo Horizonte
NOT_YET_RECRUITING
Chronos Pesquisa Clínica
Brasília
NOT_YET_RECRUITING
Instituto de Pesquisa clinica de Campinas
Campinas
NOT_YET_RECRUITING
Trial Tech
Curitiba
NOT_YET_RECRUITING
Clinilive
Maringá
NOT_YET_RECRUITING
Instituto Atena de Pesquisa Clinica
Natal
NOT_YET_RECRUITING
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro
NOT_YET_RECRUITING
Instituto Apice
Salvador
NOT_YET_RECRUITING
CPQuali Pesquisa Clínica
São Paulo
NOT_YET_RECRUITING
Clinica Viver - Centro de Desospitalizacao Humana
São Paulo
NOT_YET_RECRUITING
PSEG Centro de Pesquisa Clínica
São Paulo
NOT_YET_RECRUITING
China (8)
The Second Xiangya Hospital of Central South University
Changsha
NOT_YET_RECRUITING
The Fourth People's Hospital of Chengdu
Chengdu
NOT_YET_RECRUITING
The Seventh People's Hospital of Hangzhou
Hangzhou
NOT_YET_RECRUITING
Suzhou Guangji Hospital
Suzhou
NOT_YET_RECRUITING
Tianjin Anding Hospital
Tianjin
NOT_YET_RECRUITING
Wuhu Hospital of Beijing Anding hospital
Wuhu
NOT_YET_RECRUITING
Xi An Mental Health Center
Xi'an
NOT_YET_RECRUITING
Zhumadian Psychiatric Hospital
Zhumadian
NOT_YET_RECRUITING
India (13)
Galaxy Superspeciality Hospital
Aurangabad
NOT_YET_RECRUITING
All India Institute of Medical Sciences (AIIMS) - Bhopal
Bhopal
NOT_YET_RECRUITING
Rajiv Gandhi Government General Hospital
Chennai
NOT_YET_RECRUITING
Graphic Era Institute of Medical Sciences and Hospital
Dehradun
NOT_YET_RECRUITING
Dharwad Institute Of Mental Health And Neurosciences
Dharwad
NOT_YET_RECRUITING
Calida Rehab - Karjat
Karjat
NOT_YET_RECRUITING
Shree Mahalaxmi DIATONE Institute
Kolhāpur
NOT_YET_RECRUITING
Dr. Ram Manohar Lohia Institute of Medical Sciences
Lucknow
NOT_YET_RECRUITING
Career Institute of Medical Sciences and Hospital - Lucknow
Lucknow
NOT_YET_RECRUITING
D.Y. Patil Hospital
Navi Mumbai
NOT_YET_RECRUITING
Medipoint Hospitals Pvt. Ltd.
Pune
NOT_YET_RECRUITING
Lifepoint Multispeciality Hospital
Pune
NOT_YET_RECRUITING
Sowmanasya Hospital and Institute of Psychiatry
Tiruchirappalli
NOT_YET_RECRUITING
Japan (16)
Uematsu Mental Clinic
Chikugo
NOT_YET_RECRUITING
Horikoshi Mental Somatic Clinic
Fukushima
NOT_YET_RECRUITING
Seinan Hospital
Hachinohe
NOT_YET_RECRUITING
Fujimidai Hospital
Hiratsuka
NOT_YET_RECRUITING
Rainbow and Sea Hospital
Karatsu
NOT_YET_RECRUITING
National Center of Neurology and Psychiatry
Kodaira
NOT_YET_RECRUITING
Yuge Hospital
Kumamoto
NOT_YET_RECRUITING
Hirota Clinic
Kurume
NOT_YET_RECRUITING
Asuka Hospital
Machida
NOT_YET_RECRUITING
Arata Clinic
Nagasaki
NOT_YET_RECRUITING
Yutaka Clinic
Sagamihara
NOT_YET_RECRUITING
Sho Midori Hospital
Saitama
NOT_YET_RECRUITING
Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi
Tokyo
NOT_YET_RECRUITING
Okehazama Hospital
Toyoake
NOT_YET_RECRUITING
Yamagata Sakuracho Hospital
Yamagata
NOT_YET_RECRUITING
Shioiri Mental Clinic
Yokosuka
NOT_YET_RECRUITING
Taiwan (10)
Changhua Christian Hospital
Changhua
NOT_YET_RECRUITING
Keelung Chang Gung Memorial Hospital
Keelung
NOT_YET_RECRUITING
Chung Shan Medical University Hospital
Taichung
NOT_YET_RECRUITING
National Cheng Kung University Hospital
Tainan
NOT_YET_RECRUITING
National Taiwan University Hospital
Taipei
NOT_YET_RECRUITING
Taipei City Hospital - Songde Branch
Taipei
NOT_YET_RECRUITING
Taipei Medical University Hospital
Taipei
NOT_YET_RECRUITING
Taipei Veterans General Hospital
Taipei
NOT_YET_RECRUITING
Tri-Service General Hospital
Taipei
NOT_YET_RECRUITING
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District
NOT_YET_RECRUITING
United States (31)
Atlanta Center for Medical Research
Atlanta , Georgia
Augusta University
Augusta , Georgia
NOT_YET_RECRUITING
Northwest Clinical Research Center
Bellevue , Washington
Clinical Innovations, Inc. dba CITrials
Bellflower , California
McLean Hospital
Belmont , Massachusetts
Re:Cognition Health - Chicago
Chicago , Illinois
Magno Medical Research Group
Cooper City , Florida
Adams Clinical Dallas
DeSoto , Texas
University of Oregon
Eugene , Oregon
Re:Cognition Health - Fort Worth
Fort Worth , Texas
CBH Health
Gaithersburg , Maryland
NOT_YET_RECRUITING
Collaborative Neuroscience Research, LLC
Garden Grove , California
Institute of Living
Hartford , Connecticut
Insight Clinical Trials
Independence , Ohio
Innovative Clinical Research
Lauderhill , Florida
Pillar Clinical Research- Little Rock
Little Rock , Arkansas
Accel Research Sites - Maitland Clinical Research Unit
Maitland , Florida
Wellness Research Center
Miami , Florida
NOT_YET_RECRUITING
Vital Medical Research
Miami , Florida
CLA Research
Naples , Florida
Yale University School of Medicine
New Haven , Connecticut
NOT_YET_RECRUITING
Adams Clinical Harlem
New York , New York
Apg Research, Llc
Orlando , Florida
Adams Clinical Philadelphia
Philadelphia , Pennsylvania
Arch Clinical Trials
St Louis , Missouri
Stanford University School of Medicine
Stanford , California
PsychMe
Tampa , Florida
NOT_YET_RECRUITING
Collaborative Neuroscience Research, LLC
Torrance , California
Sunwise Clinical Research
Walnut Creek , California
Adams Clinical Watertown
Watertown , Massachusetts
University of Massachusetts Chan Medical School
Worcester , Massachusetts
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
55 Years
Healthy volunteers
No
Start date
10.02.2026
Completion date
01.11.2027
Registry ID
NCT07410507
Source
clinicaltrials.gov
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