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Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia
RecruitingPhase 3
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
Who can join
Ages 18 to 65 · All sexes
Full eligibility criteria
Inclusion Criteria: * Able to provide ICF * Willing to be hospitalized for duration of the study * Diagnosis of schizophrenia as defined by DSM-5 * BMI - 18-40 * PANSS 80-120 Exclusion Criteria: * Sexually active m/f not willing to adhere to highly effect birth control * Breast feeding * Increase in PANSS of \> 20% between screening and baseline * History of resistant treatment to schizophrenia medications * DSM-5 diagnosis other than schizophrenia * Risk of suicidal behavior * Risk of violent or destructive behavior * Clinically significant tardive dyskinesia determined by a score of ≥3 on Item 8 of the AIMS at Screening * Score of ≥3 on the BARS global clinical assessment of akathisia at Screening * Insulin dependent diabetes * Known ischemic heart disease or any history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery * History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the patient
About the study
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.
What is being tested
- LB-102 (50 mg tablet) (drug)
- LB-102 (100 mg tablet) (drug)
- Placebo (other)
Sponsor: LB Pharmaceuticals Inc. · Participants: 456 · Started: Mar 25, 2026
Contact the study team
- Branislav Mancevski, MD · Phone: 212-605-0300
Official record on ClinicalTrials.gov — NCT07363577
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.