NCT07734493 · Leal Therapeutics, Inc
A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia
What this study is about
The purpose of this clinical trial is to learn whether the experimental drug LTX-001 is safe and well tolerated in adults with a diagnosis of schizophrenia who are having a recent worsening of their symptoms (an acute exacerbation).
View original scientific description
The purpose of this clinical trial is to learn whether the investigational drug LTX-001 is safe and well tolerated in adults with a diagnosis of schizophrenia who are having a recent worsening of their symptoms (an acute exacerbation). Additional questions it aims to answer are: * how does the amount of the study drug in the body change over time (pharmacokinetics) * how does the study drug affect the symptoms of schizophrenia * how do certain markers in the blood change after administration of LTX-001 (pharmacodynamics) Researchers will compare different dose levels of LTX-001 to an inactive product (placebo) to see what differences there are between the two treatments. After successfully screening for the study, participants will stay in a research unit for about five weeks and return one week later for a follow-up visit.
Interventions
DRUG
LTX-001 once daily
LTX-001 40 mg and 60 mg administered as oral suspension
DRUG
Placebo
Oral suspension without LTX-001
DRUG
LTX-001 twice daily
LTX-001 30 mg and 60 mg administered as oral suspension
Primary outcome measures
Safety and Tolerability - Adverse Events
Time frame: Screening through Day 42
Incidence and severity of treatment-emergent adverse events (TEAEs), and treatment-emergent serious adverse events (TESAEs).
Safety and Tolerability - Clinical Laboratory Tests
Time frame: Screening through Day 42
Clinical laboratory tests (including serum chemistry, hematology, urinalysis)
Safety and Tolerability - Electrocardiograms (ECG)
Time frame: Screening through Day 42
ECGs will measure heart rate (HR), QRS complex and QT, QTcF, and PR intervals
Safety and Tolerability - Physical and Neurological Exams
Time frame: Screening through Day 42
Physical and neurological exams will be performed periodically to ensure participant safety.
Safety and Tolerability - Suicidality
Time frame: Screening through Day 42
Suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Safety and Tolerability - Extrapyramidal Symptoms
Time frame: Screening through Day 42
Extrapyramidal symptoms (EPS) as assessed by the Modified Simpson-Angus Scale (M-SAS), the Abnormal Involuntary Movement Scale (AIMS) and the Barnes Akathisia Rating scale (BARS)
Vital signs - blood pressure
Time frame: Screening through Day 42
Vital signs will be collected, including blood pressure (mm Hg)
Vital Signs - heart rate
Time frame: Screening through Day 42
Vital signs will be collected, including heart rate (beats per minute)
Vital Signs - respiratory rate
Time frame: Screening through Day 42
Vital signs will be collected, including respiratory rate (breaths per minute)
Vital Signs - body temperature
Time frame: Screening through Day 42
Vital signs will be collected, including body temperature (°C or °F)
Vital Signs - total body weight
Time frame: Screening through Day 42
Vital signs will be collected, including total body weight (kilograms)
Vital Signs - height
Time frame: Screening through Day 42
Vital signs will be collected, including height (centimeters)
Vital Signs - Body Mass Index (BMI)
Time frame: Screening through Day 42
Body Mass Index (BMI) will be calculated using the values of total body weight and height, with the formula BMI = weight in kg/(height in cm)\^2.
Ocular evaluation - Best Corrected Visual Acuity (BCVA)
Time frame: Screening through Day 42
Ocular evaluations, including Best Corrected Visual Acuity (BCVA) will be performed
Ocular evaluation - dilated Color Fundus Photography (CFP)
Time frame: Screening through Day 42
Ocular evaluations, including dilated Color Fundus Photography (CFP) will be performed
Ocular evaluation - Fundus Autofluorescence (FAF)
Time frame: Screening through Day 42
Ocular evaluations, including Fundus Autofluorescence (FAF) will be performed
Ocular evaluation - dilated Optical Coherence Tomography (OCT)
Time frame: Screening through Day 42
Ocular evaluations, including dilated Optical Coherence Tomography (OCT) of the macula and optic nerve will be performed
Ocular evaluation - slit lamp examination
Time frame: Screening through Day 42
Ocular evaluations, including slit lamp examination with measurement of intraocular pressure (IOP) will be performed
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- BMI \> 17.5 and \< 38.0 kg/m2 and a total body weight \> 50.0 kg (110 lbs)
- Primary diagnosis of schizophrenia per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5-TR)
- Experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months prior to screening for the study
- PANSS total score ≥ 80 at the time of screening for the study
- Not currently on antipsychotic medication, or is willing to discontinue all prohibited psychotropic medications prior to and during the trial period
- Sexually active adults must be willing to use an acceptable contraceptive method throughout the study
Exclusion criteria
- Evidence of organ dysfunction or any clinically significant abnormal finding at physical examination
- History of treatment resistance (e.g., failure to respond to ≥ 2 adequate antipsychotic trials) or failure to respond to use of clozapine
- Current DSM-5-TR diagnosis other than schizophrenia
- Pregnant or lactating female
- Substance use disorder within 1 year prior to screening or recreational use of drugs within 3 months prior to screening
- Moderate to severe alcohol use disorder as per DSM-5-TR within the past year or excessive use of alcohol within 12 months prior to screening
- Positive testing for human immunodeficiency virus (HIV)-1 and -2 antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening
Where
- Little Rock, Arkansas
- Los Alamitos, California
- DeLand, Florida
- Hollywood, Florida
- Miami Lakes, Florida
- Decatur, Georgia
- Gaithersburg, Maryland
- Marlton, New Jersey
- Richardson, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 4, 2026 · Source of record for eligibility and locations