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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT07363577

Run by

LB Pharmaceuticals Inc.

People needed

456

Starts

2026-03-25

Expected to finish

2027-10-01

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pillar Clinical Research — Bentonville, Arkansas, United States (enrolling)
• Pillar Clinical Research — Little Rock, Arkansas, United States (enrolling)
• Woodland International Research Group — Little Rock, Arkansas, United States (enrolling)
• ProScience Research Group — Culver City, California, United States (enrolling)
• CenExel — Garden Grove, California, United States (enrolling)
• Synergy San Diego — Lemon Grove, California, United States (enrolling)
• Clinical Innovations, Inc. — Riverside, California, United States (enrolling)
• Health Synergy Clinical Research — Boynton Beach, Florida, United States (enrolling)
• Innovative Clinical Research — Miami Lakes, Florida, United States (enrolling)
• Accelerated Clinical Trial — Snellville, Georgia, United States (enrolling)
• Pillar Clinical Research — Chicago, Illinois, United States (enrolling)
• Arch Clinical Trials — St Louis, Missouri, United States (enrolling)
• Neuro-Behavioral Clinical Research — North Canton, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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