Recent Updates
Recently added Catalysts

LY4256984

Phase 1

ALS (Amyotrophic Lateral Sclerosis) | Small molecule | Neurology |Eli Lilly and Company|Trials Updated: Sep 22, 2026

LY4256984 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Aug 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment96

FDA Designations

No designations recorded

LY4256984 clinical trials

LY4256984 · 3 trials · 2 indications

Phase 1 3
NCT07571174A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis
RECRUITING32 Analytics
NCT07571200A Master Protocol (OLMP): A Study of LY4256984 in Participants With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis
RECRUITING32 Analytics
NCT07100119A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral SclerosisALS (Amyotrophic Lateral Sclerosis)
RECRUITING32 Analytics
PHASE1RECRUITING
A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis
Amyotrophic Lateral SclerosisUnlock trial analytics
PHASE1RECRUITING
A Master Protocol (OLMP): A Study of LY4256984 in Participants With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral SclerosisUnlock trial analytics
PHASE1RECRUITING
A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis
ALS (Amyotrophic Lateral Sclerosis)Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline Up to Week 96
Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA)
Baseline Up to Week 96
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
Baseline up to Approximately Day 253

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

Secondary Endpoints

Pharmacokinetics (PK): Plasma Area Under the Concentration Versus Time Curve (AUC) of LY4256984
Baseline up to Approximately Day 253
PK: Plasma Maximum Concentration (Cmax) of LY4256984
Baseline up to Approximately Day 253
PK: Cerebrospinal Fluid Concentrations (CSF) of LY4256984
Baseline up to Approximately Day 253
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY4256984EXPERIMENTALLY4256984 administered intrathecally (IT)
LY4256984 (Cohorts 1-4)EXPERIMENTALMultiple ascending doses (MAD) of LY4256984 administered intrathecally (IT)
PlaceboPLACEBO_COMPARATORAdministered IT

Interventions

NameTypeDescription
LY4256984DRUGAdministered IT
PlaceboDRUGAdministered IT
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites11

Participants must meet eligibility criteria in the \[L0U-MC-OLMP\] screening protocol before entry into the treatment study. Inclusion Criteria: * Have completed the main treatment period/phase as well as any off-treatment period/phase of Study OWAA, the parent study for this ISA. Exclusion Crite...

Countries:BelgiumCanadaGermanyNetherlandsSpain
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWSep 22, 2026NCT07571174lastUpdatePostDate: changed
LOWSep 22, 2026NCT07571200lastUpdatePostDate: changed
LOWSep 22, 2026NCT07571174lastUpdatePostDate: changed
LOWSep 22, 2026NCT07571200lastUpdatePostDate: changed
LOWAug 24, 2026NCT07571174lastUpdatePostDate: changed
LOWAug 24, 2026NCT07571200lastUpdatePostDate: changed
LOWAug 24, 2026NCT07571174lastUpdatePostDate: changed
LOWAug 24, 2026NCT07571200lastUpdatePostDate: changed

Frequently asked questions about LY4256984

What is LY4256984 used for?

LY4256984 is an investigational small molecule being developed for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. It is currently in Phase 1 clinical trials studying participants with sporadic ALS. The drug is being evaluated in placebo-controlled, double-blind studies to assess its safety and tolerability in this patient population.

Who makes LY4256984?

LY4256984 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is sponsoring multiple Phase 1 clinical trials of LY4256984 in participants with sporadic amyotrophic lateral sclerosis across several countries including Belgium, Canada, Germany, Netherlands, and Spain.

What phase is LY4256984 in?

LY4256984 is in Phase 1 clinical development for amyotrophic lateral sclerosis (ALS). It is an investigational drug that has not yet been approved by regulatory authorities. The ongoing Phase 1 trials are recruiting participants with sporadic ALS to evaluate the drug's safety, tolerability, and pharmacokinetics in a controlled clinical setting.

What clinical trials is LY4256984 in?

LY4256984 is being studied in three Phase 1 clinical trials: NCT07100119, a study in participants with sporadic ALS; NCT07571174, a substudy in participants with sporadic ALS; and NCT07571200, a master protocol study in participants with ALS. All three trials are actively recruiting participants in Belgium, Canada, Germany, Netherlands, and Spain.

Is LY4256984 FDA approved?

LY4256984 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials for amyotrophic lateral sclerosis (ALS). The drug is being studied in placebo-controlled, double-blind trials to evaluate its safety and tolerability in participants with sporadic ALS, but it has not yet completed the clinical development process required for regulatory approval.