NCT07363577RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 456 (estimated)
- First submitted
- 26 Dec 2025
- Start date
- 25 Mar 2026
- Primary completion date
- Jun 2027
- Lead sponsor
- LB Pharmaceuticals Inc.
- Diseases
- Schizophrenia
- NCT number
- NCT07363577
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 456
- From 25 Mar 2026 to the primary completion date, Jun 2027
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of resistant treatment to schizophrenia medications
- 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
Other
- Sexually active m/f not willing to adhere to highly effect birth control
- Breast feeding
- Increase in PANSS of \> 20% between screening and baseline
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pillar Clinical Research Coordinator of this site? Confirm its status | Bentonville | United States | Recruiting |
| Health Synergy Clinical Research Coordinator of this site? Confirm its status | Boynton Beach | United States | Recruiting |
| Pillar Clinical Research Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| ProScience Research Group Coordinator of this site? Confirm its status | Culver City | United States | Recruiting |
| CenExel Coordinator of this site? Confirm its status | Garden Grove | United States | Recruiting |
| Synergy San Diego Coordinator of this site? Confirm its status | Lemon Grove | United States | Recruiting |
| Pillar Clinical Research Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Woodland International Research Group Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Innovative Clinical Research Coordinator of this site? Confirm its status | Miami Lakes | United States | Recruiting |
| Neuro-Behavioral Clinical Research Coordinator of this site? Confirm its status | North Canton | United States | Recruiting |
| Clinical Innovations, Inc. Coordinator of this site? Confirm its status | Riverside | United States | Recruiting |
| Accelerated Clinical Trial Coordinator of this site? Confirm its status | Snellville | United States | Recruiting |
| Arch Clinical Trials Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.