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RECRUITING
NCT07100119
PHASE1

A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-08-05

Completion Date

2027-09

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

DRUG

LY4256984

Administered IT

DRUG

Placebo

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