Tests LY4256984 safety in adults with sporadic ALS
Tests the drug LY4256984, given into the spine, in adults with ALS.
Plain-language title generated from the registry record
Registry title: A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis
Key facts
- Where
- Leuven, BelgiumSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with sporadic ALS (amyotrophic lateral sclerosis). It tests how safe and well tolerated LY4256984 is when given into the spine.
- Age
- 18 Years to 75 Years
- Sex
- All sexes can join.
- Disease stage
- Definite, possible, or probable sporadic ALS, with symptoms that began within 24 months of Screening.
Main reasons for not taking part
- Another neurodegenerative disease, or significant dementia or severe cognitive problems
- Significant kidney impairment (estimated glomerular filtration rate <60 mL/min/1.73 m²)
- Liver tests (ALT, AST or total bilirubin) greater than 2 x upper limit of normal
- Heart tracing (12-lead ECG) abnormality that raises the risks of taking part
- Clinically significant abnormalities in the lumbar spine
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07100119, who can take part
Where in Belgium
- UZ LeuvenLeuven, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07100119EU 2025-521295-60-00
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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/m²) (inclusive).
Exclusion: Show clinically significant abnormalities in lumbar spine previously known or determined by screening lumbar X-ray or fluoroscopy (if performed); Have a history of another neurodegenerative disease or significant dementia/severe cognitive problems; Have a significant renal impairment (estimated glomerular filtration rate <60 milliliters per minute [mL/min]/1.73 m²); 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 serum alanine aminotransferase (ALT), aspartate transferase (AST), or total bilirubin levels greater than 2 x upper limit of normal; 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.