NCT07100119RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 6 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 31 Jul 2025
- Start date
- 5 Aug 2025
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Eli Lilly and Company
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT07100119
- EU CT number
- 2025-521295-60-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 32
- From 5 Aug 2025 to the primary completion date, 31 Aug 2027
- 12 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Show clinically significant abnormalities in lumbar spine previously known or determined by screening lumbar X-ray or fluoroscopy (if performed)
Other illness
- 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).
Lab values
- 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.
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Heritage Medical Research Clinic Coordinator of this site? Confirm its status | Calgary | Canada | Not yet recruiting |
| Walter Mackenzie Health Sciences Centre Coordinator of this site? Confirm its status | Edmonton | Canada | Not yet recruiting |
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Not yet recruiting |
| Montreal Neurological Institute and Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Sunnybrook Research Institute Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Luebeck | Germany | Recruiting |
| Rostock University Medical Center Coordinator of this site? Confirm its status | Rostock | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.