Recruiting
Phase 1

LTX-001

Sponsor:

Leal Therapeutics, Inc

Code:

NCT07734493

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

LTX-001 once daily

Placebo

LTX-001 twice daily

Study Details

Brief summary:

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.

Conditions

Schizophrenia

Study ID

NCT07734493

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Placebo

experimental: LTX-001 once daily

LTX-001

experimental: LTX-001 twice daily

LTX-001

Interventions

LTX-001 once daily

LTX-001 40 mg and 60 mg administered as oral suspension

Placebo

Oral suspension without LTX-001

LTX-001 twice daily

LTX-001 30 mg and 60 mg administered as oral suspension

Primary outcome measure

  • Safety and Tolerability - Adverse Events [ Time Frame: Screening through Day 42 ]
  • Safety and Tolerability - Clinical Laboratory Tests [ Time Frame: Screening through Day 42 ]
  • Safety and Tolerability - Electrocardiograms (ECG) [ Time Frame: Screening through Day 42 ]
  • Safety and Tolerability - Physical and Neurological Exams [ Time Frame: Screening through Day 42 ]
  • Safety and Tolerability - Suicidality [ Time Frame: Screening through Day 42 ]
  • Safety and Tolerability - Extrapyramidal Symptoms [ Time Frame: Screening through Day 42 ]
  • Vital signs - blood pressure [ Time Frame: Screening through Day 42 ]
  • Vital Signs - heart rate [ Time Frame: Screening through Day 42 ]
  • Vital Signs - respiratory rate [ Time Frame: Screening through Day 42 ]
  • Vital Signs - body temperature [ Time Frame: Screening through Day 42 ]
  • Vital Signs - total body weight [ Time Frame: Screening through Day 42 ]
  • Vital Signs - height [ Time Frame: Screening through Day 42 ]
  • Vital Signs - Body Mass Index (BMI) [ Time Frame: Screening through Day 42 ]
  • Ocular evaluation - Best Corrected Visual Acuity (BCVA) [ Time Frame: Screening through Day 42 ]
  • Ocular evaluation - dilated Color Fundus Photography (CFP) [ Time Frame: Screening through Day 42 ]
  • Ocular evaluation - Fundus Autofluorescence (FAF) [ Time Frame: Screening through Day 42 ]
  • Ocular evaluation - dilated Optical Coherence Tomography (OCT) [ Time Frame: Screening through Day 42 ]
  • Ocular evaluation - slit lamp examination [ Time Frame: Screening through Day 42 ]

Central Contacts and Locations

Central contacts

Clinical Trials Information Medical Monitor

267-503-4800clinical.trials@lealtx.com

Locations

Pillar Clinical Research, LLC

Recruiting

Little Rock, Arkansas, United States, 72204

Contacts

Leslie Smith

Studies@pillarhc.com

Principal Investigator:

Leslie Smith, MD

Collaborative Neuroscience Research, LLC

Recruiting

Los Alamitos, California, United States, 90720

Contacts

Study Recruiter

(714)-891-0971

Principal Investigator:

David Walling, PhD

Behavioral Clinical Research, Inc.

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Leandro Rueda

lrueda@segaltrials.com

Principal Investigator:

Olga Lapeyra, MD

CenExel Hollywood FL

Recruiting

Hollywood, Florida, United States, 33024

Contacts

Edwin A Gomez

954-990-7649

Principal Investigator:

Edwin A Gomez, MD

Innovative Clinical Research, Inc.

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

Leandro Rueda

lrueda@segaltrials.com

Principal Investigator:

Rishi Kakar, MD

CenExel iResearch, LLC

Recruiting

Decatur, Georgia, United States, 30030

Contacts

Michael Mahaffey

m.mahaffey@cenexel.com

Principal Investigator:

Kimball Johnson, MD

CBH Health LLC., dba CenExel Gaithersburg MD

Recruiting

Gaithersburg, Maryland, United States, 20877

Contacts

Elia Acevedo-Diaz

301-251-4702

Principal Investigator:

Elia Acevedo-Diaz, MD

Hassman Research Institute, LLC

Recruiting

Marlton, New Jersey, United States, 08053

Contacts

Lisa Wilkins

888-437-4104L.Wilkins@CenExel.com

Principal Investigator:

Elan Cohen, MD

Pillar Clinical Research, LLC

Recruiting

Richardson, Texas, United States, 75080

Contacts

Scott Bartley

studies@pillarhc.com

Principal Investigator:

Scott Bartley, MD

More Information

Sponsor

Leal Therapeutics, Inc

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • schizophrenia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Leal Therapeutics, Inc on 2026-08-21.