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 studyand attend required study visits, and are willing and able to follow studyprocedures 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-5criteria:

• 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 thepast 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 ifthey received active treatment, within 90 days or 5 half-lives (whichever is longer)before screening