This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms.

The trial is divided into three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.

Inclusion Criteria:

• Meet the diagnostic criteria for major depressive disorder

• Are on a stable standard of care medication for major depressive disorder

• 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

Exclusion Criteria:

• Have a lifetime history or current diagnosis of the following:

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

• Have type 1 diabetes mellitus, or a history of

  • ketoacidosis, or
  • hyperosmolar state or coma.

• Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening

• Are actively suicidal or deemed a 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.