LB-102 for Stable Schizophrenia: Long-Term Safety and Tolerability Study

This study is testing the long-term safety and how well people tolerate a medication called LB-102 for adults with stable schizophrenia. You might be able to join if you are between 18 and 65 years old, have stable schizophrenia, and are currently taking an oral antipsychotic. You also need to be medically stable and have a stable living situation. The main goal is to see how many side effects (adverse events) happen over 52 weeks while taking LB-102. This study is for people who might not be responding well to their current medication, are having side effects, or have finished other LB-102 studies.

Study design
This is a Phase 3, open-label (meaning everyone knows what treatment they are receiving), multicenter study planning to enroll about 900 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will evaluate safety and tolerability for 52 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07369154

52-week Open Label Safety-Tolerability Study

Recruiting
PHASE3Ages 18–65InterventionalTreatment
LB Pharmaceuticals Inc.
~900 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:LB-102

At a glance

Recruiting sites
23 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate long term safety and tolerability of LB-102 by evaluating the number of adverse event, incidence of treatment emergent events.
Measured over 52 weeks
Schizophrenia
23 sites across 13 states
California5
Arkansas3
Florida3
Georgia2
Texas2
Arizona1
Illinois1
Maryland1

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Eligibility criteria

Inclusion

Provide ICF
Patients clinically stable PANSS \</= 70 at screening
CGI-S \</+ 3 at screening
Medically stable
BMI 18 -40
Taking oral antipsychotic treatment for at least 30 days
Have stable living environment

Exclusion

Sexually active M/F patients not willing to use highly effective contraception
Breast feeding
History of treatment resistance to schizophrenia medications
DSM-5 current diagnosis other than schizophrenia
Risk of suicidal behavior
History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other
  • Evaluate long term safety and tolerability of LB-102 by evaluating the number of adverse event, incidence of treatment emergent events.52 weeks

    Overall adverse events, serious adverse events, incidence of treatment emergent events and adverse events which lead to study discontinuation