Adults 18 to 55, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline to Week 4 in the PANSS Total ScorePrimary· Baseline to Day 28 (4 weeks)
The Positive and Negative Syndrome Scale (PANSS) is a scale used for measuring symptom severity of patients with schizophrenia. The PANSS rating is composed of 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Patients are scored from 1 to 7 on each symptom scale. The total score of the PANSS is a minimum of 30 and a maximum of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms whereas a higher PANSS total value represents a worse outcome
Group
Value
95% CI
LB-102, 50 mg QD
-14.28
± 1.097
LB-102, 75 mg QD
-13.95
± 1.108
LB-102, 100 mg
-16.08
± 1.906
Placebo Comparator
-9.27
± 1.078
Change From Baseline to Week 4 in the CGI-S ScoreSecondary· 28 days
The Clinical Global Impressions-Severity (CGI-S) rates illness severity on a scale from 1 to 7 and has been shown to correlate with PANSS.
The CGI-S is rated on a 7-point scale commonly used in clinical settings and research to evaluate the severity of symptoms and treatment responses in patients with mental disorders. The CGI-S specifically focuses on the severity of illness at the time of assessment, where clinicians assess the patient's current condition relative to their past. The scoring is for the CGI-S:1-normal, not at all ill, 2-Borderline mentally ill, 3-Mildly ill, 4-Moderately ill,
Group
Value
95% CI
LB-102, 50 mg QD
-.72
± 0.076
LB-102, 75 mg QD
-.67
± 0.075
LB-102, 100 mg
-.84
± 0.136
Placebo Comparator
-.39
± 0.074
Adverse events — posted to ClinicalTrials.gov
Time frame: From Screening to study day 56.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center inpatient study to evaluate the efficacy and safety of LB-102 in adult patients diagnosed with acutely exacerbated schizophrenia. To determine whether LB-102 administered to patients with acutely exacerbated schizophrenia demonstrates antipsychotic efficacy, as determined by a change from Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo at 28 days. The secondary objectives of the study are to evaluate improvement in CGI-S, safety and tolerability, and pharmacokinetics.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04588129 — Receptor Occupancy of LB-102 Using Positron Emission Tomography (PET) in Healthy Volunteers
· Phase 1
· completed
NCT04187560 — Safety and Tolerability of Single and Multiple Doses of LB-102 in Healthy Adults
· Phase 1
· completed
Other recruiting trials for Schizophrenia
Currently open trials in the same condition.
NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au
· Phase 3
· recruiting
NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia
· Phase 2
· recruiting
NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)
· recruiting
NCT06758414 — CBT-CP for Veterans With SMI
· NA
· recruiting
NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis
· NA
· recruiting
Other LB Pharmaceuticals Inc. trials
Trials by the same sponsor.
NCT04588129 — Receptor Occupancy of LB-102 Using Positron Emission Tomography (PET) in Healthy Volunteers
· Phase 1
· completed
NCT04187560 — Safety and Tolerability of Single and Multiple Doses of LB-102 in Healthy Adults
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by LB Pharmaceuticals Inc.
Last refreshed: 22 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06179108.