Actively Recruiting
A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis
Led by Eli Lilly and Company · Updated on 2026-03-06
32
Participants Needed
12
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 within 24 months of screening
- Body mass index (BMI) between 18.0 and 35.0 kg/m8 inclusive
You will not qualify if you...
- History or presence of significant medical illnesses including cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematological, endocrine, psychiatric, or neurological diseases, convulsions, or clinically significant lab abnormalities
- History of another neurodegenerative disease or severe cognitive problems
- Serum alanine aminotransferase (ALT), aspartate transferase (AST), or total bilirubin levels greater than twice the upper limit of normal
- Significant renal impairment with estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m8
- Abnormal 12-lead electrocardiogram (ECG) at screening that increases study risk
- Known or newly found significant lumbar spine abnormalities on X-ray or fluoroscopy if performed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
2
Heritage Medical Research Clinic
Calgary, Canada, T2N4Z6
Not Yet Recruiting
3
Walter Mackenzie Health Sciences Centre
Edmonton, Canada, T6G 2X8
Not Yet Recruiting
4
London Health Sciences Centre
London, Canada, N6A 5A5
Not Yet Recruiting
5
Montreal Neurological Institute and Hospital
Montreal, Canada, H3A 2B4
Actively Recruiting
6
Sunnybrook Research Institute
Toronto, Canada, M4N 3M5
Actively Recruiting
7
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany, 23538
Actively Recruiting
8
Universitätsmedizin Rostock Sektion für Translationale Neurodegeneration "Albrecht Kossel" Klinik und Poliklinik für Neurologie
Rostock, Germany, 18147
Not Yet Recruiting
9
Universitätsklinikum Ulm
Ulm, Germany, 89081
Not Yet Recruiting
10
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3584
Actively Recruiting
11
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Spain, 8907
Actively Recruiting
12
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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