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

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Bipolar Disorder

Eligibility basics and study details

Study type

Interventional

Phase

Phase 2

Ages

18 to 75 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

Eli Lilly and Company

Last updated on ClinicalTrials.gov

October 7, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites