NCT07660614 A Study of LTX-002 in Adult Participants With Amyotrophic Lateral Sclerosis
| NCT ID | NCT07660614 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Leal Therapeutics, Inc |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2026-04-29 |
| Primary Completion | 2031-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 56 participants in total. It began in 2026-04-29 with a primary completion date of 2031-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will examine what happens when patients with amyotrophic lateral sclerosis (ALS) are given an investigational medication (study drug) known as LTX-002. Specifically, the researchers will be looking at safety, tolerability (if someone has any side effects from the drug), pharmacokinetics (what the body does to the study drug) and pharmacodynamics (what the study drug does to the body). The study will also investigate the effect of the drug on indicators of the severity of ALS, such as markers in blood and in the cerebrospinal fluid (the fluid that surrounds the brain and spinal cord, CSF) and on measures of the participant's ability to move, speak, and breathe.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of ALS per Gold Coast criteria * ALS symptom onset less than 36 months prior to Screening * Slow vital capacity ≥ 50% of predicted value * Body mass index ≥18 and ≤40 kg/m2 Exclusion Criteria: * Current evidence or history of a clinically significant medical condition that, in the Investigator's judgement, would impact the participant's safety, interpretation of study results, or place the participant at high risk of poor treatment compliance or of not completing the study * History of brain or spinal abnormalities on magnetic imaging (MRI) or computed tomography (CT) that might interfere with the lumbar puncture (LP), cerebrospinal fluid (CSF) circulation or safety assessments * Prior treatment with antisense oligonucleotide (ASO), small interfering RNA, stem cell therapy, or gene therapy for any indication * Tracheostomy * HIV, Hepatitis B or C infection (acute or chronic) * Presence of implanted shunt (CSF) or vascular device * Risk for uncontrolled bleeding * Pregnant or breastfeeding
Contact & Investigator
Medical Monitor
STUDY DIRECTOR
Leal Therapeutics, Inc
Frequently Asked Questions
Who can join the NCT07660614 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07660614 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07660614 currently recruiting?
Yes, NCT07660614 is actively recruiting participants. Contact the research team at clinical.trials@lealtx.com for enrollment information.
Where is the NCT07660614 trial being conducted?
This trial is being conducted at Lübeck, Germany, Milan, Italy, Torino, Italy, Utrecht, Netherlands and 1 additional location.
Who is sponsoring the NCT07660614 clinical trial?
NCT07660614 is sponsored by Leal Therapeutics, Inc. The principal investigator is Medical Monitor at Leal Therapeutics, Inc. The trial plans to enroll 56 participants.
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