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 3, 2026

Status verified date

Sep, 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

University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research Unit

Recruiting

DeLand, Florida, United States, 32720

Contacts

Bruce Rankin

bruce.rankin@accelclinical.com

Principal Investigator:

Bruce Rankin, MD

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

Sep 17, 2026

Last verified

Sep, 2026

Keywords

  • schizophrenia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Leal Therapeutics, Inc on 2026-09-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.