NCT07363577

Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia

A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate the Antipsychotic Efficacy and Safety of LB 102 in the Treatment of Adult Patients With Acute Schizophrenia

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 456 (estimated)
• Sponsor: LB Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, study designed to evaluate the efficacy, safety, tolerability, and of LB-102 versus placebo for the treatment of adult patients with an acute exacerbation of schizophrenia.

Detailed description

This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, multicenter study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of LB-102 100 mg once daily (QD) and LB-102 50 mg QD versus placebo QD for the treatment of adult patients with an acute exacerbation of schizophrenia

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	LB-102 (50 mg tablet)	LB-102 oral tablet given for six weeks
DRUG	LB-102 (100 mg tablet)	LB-102 oral tablet given for six weeks
OTHER	Placebo	Placebo tablet given orally for six weeks

Timeline

• Start date: 2026-03-25
• Primary completion: 2027-06-01
• Completion: 2027-10-01
• First posted: 2026-01-23
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study