NCT07410507

A Study of Brenipatide in Adult Participants With Schizophrenia

A Phase 2 Multicenter, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Adult Participants With Schizophrenia (RENEW-Scz-1)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 55 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 to placebo plus SoC for treatment of schizophrenia. The trial is divided into three periods as follows: Screening period will last approximately 1 month, treatment period will last a maximum of 12 months, and the follow up period will last approximately 2 months. The length of time of your study participation may last up to approximately 15 months.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Brenipatide	Administered SC
DRUG	Placebo	Administered SC

Timeline

• Start date: 2026-02-10
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2026-02-13
• Last updated: 2026-04-17

Locations

102 sites across 7 countries: United States, Argentina, Brazil, China, India, Japan, Taiwan

Regulatory

• FDA-regulated drug study