Ireland
--:--IST
Recruiting Phase 1

A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis

NCT07100119 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1
Started
2025-08-05
Last updated
2026-03-06

Condition(s) studied

ALS (Amyotrophic Lateral Sclerosis)

Investigational drug(s) / intervention(s)

LY4256984 →Placebo

LY4256984: Administered IT

Placebo: Administered IT

Study summary

The purpose of this study is to evaluate how well LY4256984 is tolerated and what side effects may occur in participants with sporadic amyotrophic lateral sclerosis (ALS). The study drug will be administered intrathecally (IT) into the spine. Blood tests will be performed to check how much LY4256984 gets into the bloodstream and how long it takes the body to eliminate it.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Have a definite, possible, or probable diagnosis of sporadic amyotrophic lateral sclerosis (ALS) made by a physician experienced with the management of ALS * ALS symptom onset as determined by the Investigator within 24 months of Screening * Have a body mass index (BMI) within the range of greater than or equal to 18.0 and less than or equal to 35.0 kilogram per square meter (kg/m²) (inclusive) Exclusion Criteria: * Have a history or presence of medical illness including, but not limited to, any cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematological, endocrine, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality * Have a history of another neurodegenerative disease or significant dementia/severe cognitive problems * Have serum alanine aminotransferase (ALT), aspartate transferase (AST), or total bilirubin levels greater than 2 x upper limit of normal. * Have a significant renal impairment (estimated glomerular filtration rate \<60 milliliters per minute \[mL/min\]/1.73 m²). * Have a 12-lead electrocardiogram (ECG) abnormality at screening, in the opinion of the investigator, that increases the risks associated with participating in the study * Show clinically significant abnormalities in lumbar spine previously known or determined by screening lumbar X-ray or fluoroscopy (if performed)

Primary outcome measure(s)

  • Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration — Baseline up to Approximately Day 253
    A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module

Trial sites (12)

FacilityCityRegionStatus
UZ Leuven Leuven Belgium Recruiting
Heritage Medical Research Clinic Calgary Canada Not Yet Recruiting
Walter Mackenzie Health Sciences Centre Edmonton Canada Not Yet Recruiting
London Health Sciences Centre London Canada Not Yet Recruiting
Montreal Neurological Institute and Hospital Montreal Canada Recruiting
Sunnybrook Research Institute Toronto Canada Recruiting
Universitätsklinikum Schleswig-Holstein Lübeck Germany Recruiting
Universitätsmedizin Rostock Sektion für Translationale Neurodegeneration "Albrecht Kossel" Klinik und Poliklinik für Neurologie Rostock Germany Not Yet Recruiting
Universitätsklinikum Ulm Ulm Germany Not Yet Recruiting
Universitair Medisch Centrum Utrecht Utrecht Netherlands Recruiting
Hospital Universitario de Bellvitge L'Hospitalet de Llobregat Spain Recruiting
Hospital Universitari i Politecnic La Fe Valencia Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07100119 on ClinicalTrials.gov ↗ ← All trials in Spain