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)
Eli Lilly and Company
Summary
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.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- No
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 *…
Interventions
- DrugBrenipatide
Administered SC
- DrugPlacebo
Administered SC
Locations (102)
- Pillar Clinical Research- Little RockLittle Rock, Arkansas
- Clinical Innovations, Inc. dba CITrialsBellflower, California
- Collaborative Neuroscience Research, LLCGarden Grove, California
- Stanford University School of MedicineStanford, California
- Collaborative Neuroscience Research, LLCTorrance, California
- Sunwise Clinical ResearchWalnut Creek, California