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 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

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.