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

NCT07363577 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • LB Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-25
Primary Completion
2027-06-30
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07363577 on ClinicalTrials.gov