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NCT07100119

A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis

StatusRecruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

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Record History

All 9 versions: 8 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment increased: 32 → 36 participants
    • Eligibility criteria expanded, about 9 words
    • Site details revised at 5 of 12 sites
  2. Site details revised at 3 of 12 sitesv8
  3. Site details revised at 2 of 12 sitesv7
  4. Site details revised at 1 of 12 sitesv6
  5. Site contacts updated at 1 of 12 sitesv5
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 10 to 12
    • Start date changed from estimate of Sep 2025 to Aug 5, 2025
    • Eligibility criteria expanded, about 47 words
    v4
  2. Site details revised at 1 of 10 sitesv2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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
Timeframe: Baseline up to Approximately Day 253

Secondary (3)

Pharmacokinetics (PK): Plasma Area Under the Concentration Versus Time Curve (AUC) of LY4256984
PK: Plasma Maximum Concentration (Cmax) of LY4256984
PK: Cerebrospinal Fluid Concentrations (CSF) of LY4256984

Arms and interventions

LY4256984 (Cohorts 1-3)Experimental

Multiple ascending doses (MAD) of LY4256984 administered intrathecally (IT)

PlaceboPlacebo comparator

Administered IT

Drugs: LY4256984, Placebo

Sites

12 sites in 5 countries

Canada 5, Germany 3, Spain 2, Belgium 1, Netherlands 1