Actively Recruiting
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
Led by Eli Lilly and Company · Updated on 2026-03-06
32
Participants Needed
12
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerance of LY4256984 in people with sporadic amyotrophic lateral sclerosis (ALS). This Phase 1 study aims to understand what side effects may occur when LY4256984 is given intrathecally (into the spine) and how the drug behaves in the body. The study includes adults aged 18 to 75 with a recent ALS diagnosis and a certain body mass index range. Participants will receive multiple ascending doses of LY4256984 or a placebo administered directly into the spine. The study is randomized and double-blinded, meaning participants receive either the drug or placebo without knowing which one. The treatment period lasts up to approximately 253 days, during which dosing and monitoring occur. Throughout the study, researchers will perform blood tests to measure how much LY4256984 reaches the bloodstream and how long it stays there. They will track side effects and serious adverse events related to the treatment from the start until about day 253. Safety assessments include checking cerebrospinal fluid drug levels, monitoring vital signs, and reviewing lumbar spine health. Participants can expect regular evaluations and laboratory tests during their involvement in the trial, which runs from screening through treatment and follow-up.
CONDITIONS
Brief 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 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/m8) (inclusive)
You will not qualify if you...
- 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 m8)
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 253 days
Participants receive multiple ascending doses of LY4256984 or placebo administered intrathecally.
Multiple dosing visits over the treatment period
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
P
Physicians interested in becoming principal investigators please 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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