A Study of Brenipatide in Adult Participants With Schizophrenia
Recruiting · NCT07410507 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
BrenipatidePlacebo
What this trial is about
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 take part
Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 15 US states.
- Pillar Clinical Research- Little Rock - Little Rock, Arkansas, United States
- Clinical Innovations, Inc. dba CITrials - Bellflower, California, United States
- Collaborative Neuroscience Research, LLC - Garden Grove, California, United States
- Catalina Research Institute, LLC - Montclair, California, United States
- Stanford University School of Medicine - Stanford, California, United States
- Collaborative Neuroscience Research, LLC - Torrance, California, United States
- Sunwise Clinical Research - Walnut Creek, California, United States
- Institute of Living - Hartford, Connecticut, United States
- Yale University School of Medicine - New Haven, Connecticut, United States
- Magno Medical Research Group - Cooper City, Florida, United States
- NextPhase Research Florida - Hollywood - Hollywood, Florida, United States
- Innovative Clinical Research - Lauderhill, Florida, United States
- Accel Research Sites - Maitland Clinical Research Unit - Maitland, Florida, United States
- Wellness Research Center - Miami, Florida, United States
- Vital Medical Research - Miami, Florida, United States
- CLA Research - Naples, Florida, United States
- Apg Research, Llc - Orlando, Florida, United States
- Atlanta Center for Medical Research - Atlanta, Georgia, United States
- Augusta University - Augusta, Georgia, United States
- Re:Cognition Health - Chicago - Chicago, Illinois, United States
- CBH Health - Gaithersburg, Maryland, United States
- McLean Hospital - Belmont, Massachusetts, United States
- Adams Clinical Watertown - Watertown, Massachusetts, United States
- University of Massachusetts Chan Medical School - Worcester, Massachusetts, United States
- Arch Clinical Trials - St Louis, Missouri, United States
- Adams Clinical Harlem - New York, New York, United States
- Insight Clinical Trials - Independence, Ohio, United States
- University of Oregon - Eugene, Oregon, United States
- Adams Clinical Philadelphia - Philadelphia, Pennsylvania, United States
- Adams Clinical Dallas - DeSoto, Texas, United States
- Re:Cognition Health - Fort Worth - Fort Worth, Texas, United States
- Northwest Clinical Research Center - Bellevue, Washington, United States
- Galaxy Superspeciality Hospital - Aurangabad, India
- Hospital das Clínicas da UFMG - Belo Horizonte, Brazil
- All India Institute of Medical Sciences (AIIMS) - Bhopal - Bhopal, India
- Chronos Pesquisa Clínica - Brasília, Brazil
- Centro Neurobiológico y de Estrés Traumático (CENydET) - Buenos Aires, Argentina
- Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM) - Buenos Aires, Argentina
- Instituto Nacional de Psicopatología (INAPsi)- FunDaMos - Buenos Aires, Argentina
- Fundación Cenit Para La Investigación En Neurociencias - CABA, Argentina
- Instituto de Pesquisa clinica de Campinas - Campinas, Brazil
- Changhua Christian Hospital - Changhua, Taiwan
- The Second Xiangya Hospital of Central South University - Changsha, China
- The Fourth People's Hospital of Chengdu - Chengdu, China
- Rajiv Gandhi Government General Hospital - Chennai, India
- Uematsu Mental Clinic - Chikugo, Japan
- Trial Tech - Curitiba, Brazil
- CEN Centro Especializado en Neurociencias - Córdoba, Argentina
- Sanatorio Morra S.A. - Córdoba, Argentina
- Instituto Kremer - Córdoba, Argentina
- Centro Médico Luquez - Córdoba, Argentina
- Graphic Era Institute of Medical Sciences and Hospital - Dehradun, India
- Dharwad Institute Of Mental Health And Neurosciences - Dharwad, India
- Horikoshi Mental Somatic Clinic - Fukushima, Japan
- Seinan Hospital - Hachinohe, Japan
- The Seventh People's Hospital of Hangzhou - Hangzhou, China
- Fujimidai Hospital - Hiratsuka, Japan
- Rainbow and Sea Hospital - Karatsu, Japan
- Calida Rehab - Karjat - Karjat, India
- Keelung Chang Gung Memorial Hospital - Keelung, Taiwan
Showing 60 of 103 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →