NCT07286175

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

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Brenipatide	Administered SC
DRUG	Placebo	Administered SC

Timeline

• Start date: 2025-11-24
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2025-12-16
• Last updated: 2026-04-17

Locations

88 sites across 8 countries: United States, Argentina, Brazil, China, India, Japan, Mexico, Puerto Rico

Regulatory

• FDA-regulated drug study