The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC), compared with placebo plus SoC in delaying the worsening of bipolar disorder symptoms.

The trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if bipolar symptoms worsen or if withdrawal from the study occurs for any reason.

Inclusion Criteria:

• Meet the diagnostic criteria for bipolar disorder I or bipolar disorder II

• 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 blinded study intervention, as directed
  • maintain electronic and paper study diaries, as applicable, and
  • complete the required questionnaires

• Are on stable standard of care medication for bipolar disorder

Exclusion Criteria:

• Have a lifetime history or current diagnosis of the following according to DSM-5 criteria:

  • schizophrenia or other psychotic disorder
  • borderline personality disorder, or
  • any eating disorder

• Have type 1 diabetes mellitus, or a history of

  • ketoacidosis, or
  • hyperosmolar state or coma

• Have evidence of moderate or severe substance or alcohol use disorder within the past 180 days prior to screening

• Are actively suicidal and or deemed to be at significant risk for suicide

• Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening

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.