Tests brenipatide added to usual care for schizophrenia
Tests brenipatide with usual care against placebo in adults with schizophrenia.
Plain-language title generated from the registry record
Registry title: A Study of Brenipatide in Adult Participants With Schizophrenia
Key facts
- Where
- Atlanta, Augusta, Bellevue, Bellflower, Belmont, Chicago, Cooper City, DeSoto, Eugene, Fort Worth, Gaithersburg, Garden Grove, Hartford, Hollywood, Independence, Lauderhill, Little Rock, Maitland, Miami, Montclair, Naples, New Haven, New York, Orlando, Philadelphia, St Louis, Stanford, Torrance, Walnut Creek, Watertown, and Worcester, United StatesSee the 32 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT07410507, who can take part
Where in United States
- Atlanta Center for Medical ResearchAtlanta, United StatesTaking people
- Augusta UniversityAugusta, United StatesTaking people
- Northwest Clinical Research CenterBellevue, United StatesTaking people
- Clinical Innovations, Inc. dba CITrialsBellflower, United StatesTaking people
- McLean HospitalBelmont, United StatesTaking people
- Re:Cognition Health - ChicagoChicago, United StatesTaking people
- Magno Medical Research GroupCooper City, United StatesTaking people
- Adams Clinical DallasDeSoto, United StatesTaking people
- University of OregonEugene, United StatesTaking people
- Re:Cognition Health - Fort WorthFort Worth, United StatesTaking people
- CBH HealthGaithersburg, United StatesTaking people
- Collaborative NeuroScience Research , LLCGarden Grove, United StatesTaking people
- Institute of LivingHartford, United StatesTaking people
- NextPhase Research Florida - HollywoodHollywood, United StatesTaking people
- Insight Clinical TrialsIndependence, United StatesTaking people
- Innovative Clinical ResearchLauderhill, United StatesTaking people
- Pillar Clinical Research - Little RockLittle Rock, United StatesTaking people
- Accel Research Sites - Maitland Clinical Research UnitMaitland, United StatesTaking people
- Vital Medical ResearchMiami, United StatesTaking people
- Wellness Research CenterMiami, United StatesTaking people
- Catalina Research Institute, LLCMontclair, United StatesTaking people
- CLA ResearchNaples, United StatesTaking people
- Yale University School Of MedicineNew Haven, United StatesTaking people
- Adams Clinical HarlemNew York, United StatesTaking people
- APG Research, LLCOrlando, United StatesTaking people
- Adams Clinical PhiladelphiaPhiladelphia, United StatesTaking people
- Arch Clinical TrialsSt Louis, United StatesTaking people
- Stanford University School of MedicineStanford, United StatesTaking people
- Collaborative Neuroscience Research LLCTorrance, United StatesTaking people
- Sunwise Clinical ResearchWalnut Creek, United StatesTaking people
- Adams Clinical WatertownWatertown, United StatesTaking people
- University of Massachusetts Chan Medical SchoolWorcester, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07410507
- Record updated
- 7 October 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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; 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.