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A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis

ConditionALS (Amyotrophic Lateral Sclerosis)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEli Lilly and Company

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY4256984

    Drug

    Administered IT

  • Placebo

    Drug

    Administered IT

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: LY4256984 (Cohorts 1-4)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration

A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module

Time frame
Baseline up to Approximately Day 253

Secondary outcomes

1

Pharmacokinetics (PK): Plasma Area Under the Concentration Versus Time Curve (AUC) of LY4256984

PK: Plasma AUC of LY4256984

Time frame
Baseline up to Approximately Day 253
2

PK: Plasma Maximum Concentration (Cmax) of LY4256984

PK: Plasma Cmax of LY4256984

Time frame
Baseline up to Approximately Day 253
3

PK: Cerebrospinal Fluid Concentrations (CSF) of LY4256984

PK: CSF Concentrations of LY4256984

Time frame
Baseline up to Approximately Day 253

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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