NCT07100119

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ALS (Amyotrophic Lateral Sclerosis)

Interventions

Type	Name	Description
DRUG	LY4256984	Administered IT
DRUG	Placebo	Administered IT

Timeline

• Start date: 2025-08-05
• Primary completion: 2027-08-01
• Completion: 2027-09-01
• First posted: 2025-08-03
• Last updated: 2026-03-06

Locations

12 sites across 5 countries: Belgium, Canada, Germany, Netherlands, Spain