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A Study of LTX-001 for Acute Exacerbation of Schizophrenia

This study is testing an investigational drug called LTX-001 in adults with schizophrenia who are experiencing a recent worsening of their symptoms. Researchers want to see if LTX-001 is safe and well-tolerated. They will compare different doses of LTX-001 (40 mg, 60 mg once daily, or 30 mg, 60 mg twice daily) to a placebo (an inactive substance) to understand how the drug affects the body and symptoms of schizophrenia. The study is looking for about 90 participants aged 18 to 55 who have a schizophrenia diagnosis and a recent acute exacerbation (relapse of symptoms). The main goal is to check for side effects and how well people tolerate the treatment over about six weeks.

Study design
This interventional study plans to enroll 90 adult participants. It will compare different doses of LTX-001 to a placebo.
What's involved
You would visit the study site 3 times and stay overnight for 35 nights (up to 49 nights). Procedures include physical exams, blood and urine tests, heart activity measurements (ECGs), and psychiatric assessments.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be measured from screening through Day 42 after starting the study.

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NCT07734493

A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia

Not Yet Recruiting
PHASE1Ages 18–55InterventionalTreatment
Leal Therapeutics, Inc
~90 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:LTX-001 once dailyPlaceboLTX-001 twice daily

At a glance

Recruiting sites
0 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability - Adverse Events
Measured over Screening through Day 42
+17 more outcomes measured

Conditions

Schizophrenia

Explore related trials

Schizophrenia

Where it's being run

10 sites across 7 states
Florida4
Arkansas1
California1
Georgia1
Maryland1
New Jersey1
Texas1

Who to contact

Clinical Trials Information Medical Monitor
[email protected]
267-503-4800
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Safety and Tolerability - Adverse EventsScreening through Day 42

    Incidence and severity of treatment-emergent adverse events (TEAEs), and treatment-emergent serious adverse events (TESAEs).

  • Safety and Tolerability - Clinical Laboratory TestsScreening through Day 42

    Clinical laboratory tests (including serum chemistry, hematology, urinalysis)

  • Safety and Tolerability - Electrocardiograms (ECG)Screening through Day 42

    ECGs will measure heart rate (HR), QRS complex and QT, QTcF, and PR intervals

  • Safety and Tolerability - Physical and Neurological ExamsScreening through Day 42

    Physical and neurological exams will be performed periodically to ensure participant safety.

  • Safety and Tolerability - SuicidalityScreening through Day 42

    Suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)

  • Safety and Tolerability - Extrapyramidal SymptomsScreening 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 pressureScreening through Day 42

    Vital signs will be collected, including blood pressure (mm Hg)

  • Vital Signs - heart rateScreening through Day 42

    Vital signs will be collected, including heart rate (beats per minute)

  • Vital Signs - respiratory rateScreening through Day 42

    Vital signs will be collected, including respiratory rate (breaths per minute)

  • Vital Signs - body temperatureScreening through Day 42

    Vital signs will be collected, including body temperature (°C or °F)

  • Vital Signs - total body weightScreening through Day 42

    Vital signs will be collected, including total body weight (kilograms)

  • Vital Signs - heightScreening through Day 42

    Vital signs will be collected, including height (centimeters)

  • Vital Signs - Body Mass Index (BMI)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)Screening through Day 42

    Ocular evaluations, including Best Corrected Visual Acuity (BCVA) will be performed

  • Ocular evaluation - dilated Color Fundus Photography (CFP)Screening through Day 42

    Ocular evaluations, including dilated Color Fundus Photography (CFP) will be performed

  • Ocular evaluation - Fundus Autofluorescence (FAF)Screening through Day 42

    Ocular evaluations, including Fundus Autofluorescence (FAF) will be performed

  • Ocular evaluation - dilated Optical Coherence Tomography (OCT)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 examinationScreening through Day 42

    Ocular evaluations, including slit lamp examination with measurement of intraocular pressure (IOP) will be performed