RecruitingPhase 1NCT07100119

A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis

A Multiple Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally Administered LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis


Sponsor

Eli Lilly and Company

Enrollment

32 participants

Start Date

Aug 5, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called LY4256984 as a potential treatment for ALS (amyotrophic lateral sclerosis, also known as Lou Gehrig's disease) — a progressive neurological condition that causes muscle weakness and paralysis. This early-phase study is primarily evaluating safety and how the drug behaves in the body. **You may be eligible if...** - You have a definite, possible, or probable diagnosis of sporadic ALS (not inherited) - Your ALS symptoms started within the last 24 months - Your BMI is between 18.0 and 35.0 kg/m² **You may NOT be eligible if...** - You have significant heart, kidney, liver, gastrointestinal, breathing, blood, or other medical conditions - You have another neurodegenerative disease or significant memory or thinking problems - Your liver enzymes (ALT, AST) or bilirubin are significantly elevated - You have significant kidney impairment - You have an abnormal ECG (heart tracing) that the investigator considers risky - You have significant spine problems found on X-ray Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLY4256984

Administered IT

DRUGPlacebo

Administered IT


Locations(12)

UZ Leuven

Leuven, Belgium

Heritage Medical Research Clinic

Calgary, Canada

Walter Mackenzie Health Sciences Centre

Edmonton, Canada

London Health Sciences Centre

London, Canada

Montreal Neurological Institute and Hospital

Montreal, Canada

Sunnybrook Research Institute

Toronto, Canada

Universitätsklinikum Schleswig-Holstein

Lübeck, Germany

Universitätsmedizin Rostock Sektion für Translationale Neurodegeneration "Albrecht Kossel" Klinik und Poliklinik für Neurologie

Rostock, Germany

Universitätsklinikum Ulm

Ulm, Germany

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT07100119


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