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LY4256984

Phase 1

ALS (Amyotrophic Lateral Sclerosis) | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Aug 24, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

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
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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
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites10

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
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Recent Changes (Last 90 Days)

LOWAug 24, 2026NCT07571174lastUpdatePostDate: changed
LOWAug 24, 2026NCT07571200lastUpdatePostDate: changed
LOWAug 24, 2026NCT07571174lastUpdatePostDate: changed
LOWAug 24, 2026NCT07571200lastUpdatePostDate: changed
LOWJul 17, 2026NCT07571174lastUpdatePostDate: changed
LOWJul 17, 2026NCT07571200lastUpdatePostDate: changed
LOWJul 17, 2026NCT07571174lastUpdatePostDate: changed
LOWJul 17, 2026NCT07571200lastUpdatePostDate: changed
LOWJun 24, 2026NCT07571174Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 24, 2026NCT07571200Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 24, 2026NCT07571174Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 24, 2026NCT07571200Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about LY4256984

What is LY4256984 used for?

LY4256984 is an investigational small molecule being developed for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. It is currently in Phase 1 clinical trials for sporadic ALS, which is the most common form of the disease.

Who makes LY4256984?

LY4256984 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and tolerability in participants with sporadic ALS.

What phase is LY4256984 in?

LY4256984 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is currently being studied in early-stage trials to assess its safety, tolerability, and pharmacokinetics in participants with sporadic ALS.

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 trials are currently recruiting participants.

Is LY4256984 the same as any other drug?

No alternative names for LY4256984 have been disclosed. The drug is identified solely by its compound number LY4256984 in clinical trial registrations and scientific literature. It is a distinct investigational small molecule being developed by Eli Lilly and Company for ALS.

What is the design of LY4256984 clinical trials?

The LY4256984 clinical trials are randomized, double-blind, and placebo-controlled. Each of the three Phase 1 studies plans to enroll 32 participants, for a total of 96 participants across the trials. The studies are recruiting adults aged 18 years and older in Belgium, Canada, Germany, Netherlands, and Spain.