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

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Bipolar Disorder

Treatments: Drug: Brenipatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07286175

27365

J2S-MC-GZMJ (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 3 patient groups, including a placebo group

Brenipatide Dose 1

Experimental group

Description:

Brenipatide administered subcutaneous (SC) + SoC.

Treatment:

Drug: Brenipatide

Brenipatide Dose 2 .

Experimental group

Description:

Brenipatide administered subcutaneous (SC) + SoC.

Treatment:

Drug: Brenipatide

Placebo

Placebo Comparator group

Description:

Placebo administered SC + SoC.

Treatment:

Drug: Placebo