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RECRUITINGPhase 1INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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) Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

DRUG

LY4256984

Administered IT

DRUG

Placebo

Administered IT

Locations (12)

UZ Leuven
Leuven, Belgium
Heritage Medical Research Clinic
Calgary, Canada
Walter Mackenzie Health Sciences Centre
Edmonton, Canada
London Health Sciences Centre
London, Canada
Montreal Neurological Institute and Hospital
Montreal, Canada
Sunnybrook Research Institute
Toronto, Canada
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany
Universitätsmedizin Rostock Sektion für Translationale Neurodegeneration "Albrecht Kossel" Klinik und Poliklinik für Neurologie
Rostock, Germany
Universitätsklinikum Ulm
Ulm, Germany
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain