A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

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