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
LB Pharmaceuticals Inc.
456 participants
Mar 25, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria12
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
LB-102 oral tablet given for six weeks
LB-102 oral tablet given for six weeks
Placebo tablet given orally for six weeks
Locations(13)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07363577