Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2025-12-10; most recent amendment 2026-07-16.
Trial Details
NCT Number NCT07286175
Lead Sponsor Eli Lilly and Company
Conditions Bipolar Disorder
Enrollment 400 participants
Start Date 2025-11-24
Primary Completion 2027-11 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-06