NCT07369154 52-week Open Label Safety-Tolerability Study
| NCT ID | NCT07369154 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | LB Pharmaceuticals Inc. |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2026-04-23 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 900 participants in total. It began in 2026-04-23 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Phase 3, open label, multicenter study designed to assess the long term safety and tolerability of LB-102 for the treatment of adult patients with stable schizophrenia
Eligibility Criteria
Inclusion Criteria: * Provide ICF * Patients clinically stable PANSS \</= 80 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07369154 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07369154 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 900 participants.
Is NCT07369154 currently recruiting?
Yes, NCT07369154 is actively recruiting participants. Contact the research team at clinicaltrials@lbpharma.us for enrollment information.
Where is the NCT07369154 trial being conducted?
This trial is being conducted at Chandler, United States, Bentonville, United States, Little Rock, United States, Little Rock, United States and 11 additional locations.
Who is sponsoring the NCT07369154 clinical trial?
NCT07369154 is sponsored by LB Pharmaceuticals Inc.. The trial plans to enroll 900 participants.
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