A Study of Brenipatide in Adult Participants With Schizophrenia
ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorEli Lilly and Company
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Brenipatide
- Placebo
Treatment groups
450 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov