NCT07467993

Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia

A Phase 2a, Randomized, Participant- and Investigator- Blinded, Parallel-group, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With DSM-5 Schizophrenia (STAR-1)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	GXV813	GXV813 administered orally.
DRUG	Placebo	Placebo administered orally.

Timeline

• Start date: 2026-03-16
• Primary completion: 2027-04-27
• Completion: 2027-04-27
• First posted: 2026-03-12
• Last updated: 2026-03-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study