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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified June 2026 by LB Pharmaceuticals Inc.
Sponsor
LB Pharmaceuticals Inc.
Information Provided by (Responsible Party)
LB Pharmaceuticals Inc.
Clinicaltrials.gov Identifier
NCT07363577
Other Study ID Numbers:
LB-102-008
First Submitted
December 25, 2025
First Posted
January 22, 2026
Last Update Posted
July 26, 2026
Last Verified
June 2026

ClinicalTrials.gov processed this data on July 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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

Condition or DiseaseIntervention/Treatment
Schizophrenia
Drug: LB-102 (50 mg tablet)Drug: LB-102 (100 mg tablet)Other: Placebo

Study Design

Study TypeInterventional
Actual Enrollment456 participants
Design AllocationRandomized
Interventional ModelSequential Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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
Study Start DateMarch 24, 2026
Actual Primary Completion Date10mos 1d from now
Actual Study Completion Date1yr 2mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
LB-102 (50 mg tablet)
• LB-102 50 mg given orally for 6 weeks
Drug: LB-102 (50 mg tablet)
LB-102 oral tablet given for six weeks
LB-102 (100 mg tablet)
LB-102 100 mg given orally for 6 weeks
Drug: LB-102 (100 mg tablet)
LB-102 oral tablet given for six weeks
Placebo
Placebo given orally for 6 weeks
Other: Placebo
Placebo tablet given orally for six weeks

Outcome Measures

Primary Outcome Measures
  1. Change from baseline to Week 6 on the Positive and Negative Syndrome Scale
    Determine whether LB-102, demonstrates antipsychotic efficacy, as determined by a change from Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo: increase in scale indicates worsening while a decrease in the scale likely indicates a response to treatment
Secondary Outcome Measures
  1. Evaluate the Safety and Tolerability of LB-102
    Evaluate the safety and tolerability of LB-102 in patients by evaluating adverse events
  2. Change in Clinical Global Impressions-Severity of Illness scale (CGI-S)
    Assess the effect of LB-102 on the treatment for schizophrenia, as determined by a change from Baseline in the Clinical Global Impressions Severity of Illness scale: whereas increase demonstrates worsening of illness and decrease in score likely indicates response to treatment

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsLB Pharmaceuticals Inc.
Locations
Pillar Clinical Research | Bentonville Arkansas, United States, 72712Pillar Clinical Research | Little Rock Arkansas, United States, 72204Woodland International Research Group | Little Rock Arkansas, United States, 72211ProScience Research Group | Culver City California, United States, 90230CenExel | Garden Grove California, United States, 92845Synergy San Diego | Lemon Grove California, United States, 92064Clinical Innovations, Inc. | Riverside California, United States, 92506Health Synergy Clinical Research | Boynton Beach Florida, United States, 33426Innovative Clinical Research | Miami Lakes Florida, United States, 33016Accelerated Clinical Trial | Snellville Georgia, United States, 30078Pillar Clinical Research | Chicago Illinois, United States, 60641Arch Clinical Trials | St Louis Missouri, United States, 63141Neuro-Behavioral Clinical Research | North Canton Ohio, United States, 44720