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

ClinicalTrials.gov ID

NCT07286175

Lead Sponsor

Eli Lilly and CompanyINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

400Estimated

Last Update Posted

Sep 4, 2026Actual

Start Date

Nov 24, 2025Actual

Primary Completion Date

Nov 2027Estimated

Completion Date

Nov 2027Estimated

Official Title

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

Brief Summary

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.

• Bipolar Disorder

• Brenipatide
• Placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Eli Lilly and CompanyINDUSTRY

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