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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
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

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumRecruiting
Heritage Medical Research Clinic
Coordinator of this site? Confirm its status
CalgaryCanadaNot yet recruiting
Walter Mackenzie Health Sciences Centre
Coordinator of this site? Confirm its status
EdmontonCanadaNot yet recruiting
London Health Sciences Centre
Coordinator of this site? Confirm its status
LondonCanadaNot yet recruiting
Montreal Neurological Institute and Hospital
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
Sunnybrook Research Institute
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
Universitaetsklinikum Schleswig-Holstein AöR
Coordinator of this site? Confirm its status
LuebeckGermanyRecruiting
Rostock University Medical Center
Coordinator of this site? Confirm its status
RostockGermanyRecruiting
Universitaetsklinikum Ulm AoR
Coordinator of this site? Confirm its status
UlmGermanyRecruiting
Bellvitge University Hospital
Coordinator of this site? Confirm its status
L'hospitalet De LlobregatSpainRecruiting
Hospital Universitario Y Politecnico La Fe
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
Universitair Medisch Centrum Utrecht
Coordinator of this site? Confirm its status
UtrechtNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.