LY4256984 for people with sporadic ALS.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional study testing intrathecal (spine) administration of LY4256984 versus placebo to characterize tolerability and side effects in people with sporadic ALS. The protocol includes blood sampling to measure how much drug reaches the bloodstream and how long it stays in the body. Eligible participants have symptom onset within 24 months and meet basic BMI and laboratory criteria, while those with significant comorbidities or major liver or kidney abnormalities are excluded. The trial is sponsored by Eli Lilly and is being conducted at centers in Belgium and Canada.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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 m²).
* 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)

Where it's running

• UZ Leuven
  Leuven, Belgium Recruiting
• Heritage Medical Research Clinic
  Calgary, Canada Recruiting
• London Health Sciences Centre
  London, Canada Recruiting
• Montreal Neurological Institute and Hospital
  Montreal, Canada Recruiting
• Sunnybrook Research Institute
  Toronto, Canada Recruiting
• Universitätsklinikum Schleswig-Holstein
  Lübeck, Germany Recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.