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LY4005130

Phase 2

Alopecia Areata | Small molecule | Dermatology |Eli Lilly and Company|Last Updated: Aug 24, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

LY4005130 · 3 trials · 4 indications

Phase 2 2Phase 1 1
NCT07533006A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)Alopecia Areata
RECRUITING60 Analytics
NCT07533019A Study of LY4005130 in Adult Participants With Non-Segmental VitiligoVitiligo
RECRUITING66 Analytics
PHASE2RECRUITING
A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)
Alopecia AreataUnlock trial analytics
PHASE2RECRUITING
A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
VitiligoUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Less than or Equal to (≤) 20
Week 24
Percentage of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI) 75
Week 24
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline to Study Completion (Up to 26 Weeks)

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

Secondary Endpoints

Percentage of Participants Achieving At Least 50 Percent (%) Improvement from Baseline (SALT50)
Week 24
Pharmacokinetics (PK): Trough Concentrations of LY4005130
Baseline Through Week 20
Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Scalp Biopsy
Baseline, Week 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY4005130EXPERIMENTALLY4005130 administered intravenously (IV)
PlaceboPLACEBO_COMPARATORPlacebo administered IV
LY4005130 Part A (SAD) SCEXPERIMENTALA single-ascending dose of LY4005130 administered subcutaneously (SC)
Placebo Part A (SAD) SCPLACEBO_COMPARATORPlacebo administered SC
LY4005130 Part A (SAD) IVEXPERIMENTALA single-ascending dose of LY4005130 administered intravenously (IV)
Placebo Part A (SAD) IVPLACEBO_COMPARATORPlacebo administered IV
LY4005130 Part A (SAD) OptionalEXPERIMENTALA single-ascending dose of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts
Placebo Part A (SAD) OptionalPLACEBO_COMPARATORA single-ascending dose of placebo administered either SC or IV depending on emerging data from earlier cohorts
LY4005130 Part B (MAD) IVEXPERIMENTALMultiple-ascending doses of LY4005130 administered IV
Placebo Part B (MAD) IVPLACEBO_COMPARATORPlacebo administered IV
LY4005130 Part B (MAD) SC or IVEXPERIMENTALMultiple-ascending doses of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts
Placebo Part B (MAD) SC or IVPLACEBO_COMPARATORMultiple-ascending doses of placebo administered either SC or IV depending on emerging data from earlier cohorts
LY4005130 Part B (MAD) OptionalEXPERIMENTALMultiple-ascending doses of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts
Placebo Part B (MAD) OptionalPLACEBO_COMPARATORMultiple-ascending doses of placebo administered either SC or IV depending on emerging data from earlier cohorts

Interventions

NameTypeDescription
LY4005130DRUGAdministered IV
PlaceboDRUGAdministered IV
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersNo
Study Sites30

Inclusion Criteria: * Have severe Alopecia Areata (AA) that meets all of the following criteria: * Hair loss encompassing ≥50% and ≤90% of the scalp, as measured by Severity of Alopecia Tool (SALT) score * The duration of the current episode of severe AA is at least 6 months and does not excee...

Countries:United StatesCanadaChinaNetherlandsPolandSouth KoreaUnited KingdomBelgium
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Recent Changes (Last 90 Days)

LOWAug 24, 2026NCT07533019lastUpdatePostDate: changed
LOWAug 24, 2026NCT07533006lastUpdatePostDate: changed
LOWAug 24, 2026NCT07533019lastUpdatePostDate: changed
LOWAug 24, 2026NCT07533006lastUpdatePostDate: changed
LOWAug 6, 2026NCT07533019lastUpdatePostDate: changed
LOWAug 6, 2026NCT07533006lastUpdatePostDate: changed
LOWAug 6, 2026NCT07533019lastUpdatePostDate: changed
LOWAug 6, 2026NCT07533006lastUpdatePostDate: changed
LOWJul 30, 2026NCT07533019Enrollment: 60 → 66
LOWJul 30, 2026NCT07533019Enrollment: 60 → 66
MEDIUMJul 24, 2026NCT06690996TRIAL_REMOVED: changed
MEDIUMJul 24, 2026NCT06690996TRIAL_REMOVED: changed
LOWJul 17, 2026NCT07533019lastUpdatePostDate: changed
LOWJul 17, 2026NCT07533006lastUpdatePostDate: changed
LOWJul 17, 2026NCT07533019lastUpdatePostDate: changed
LOWJul 17, 2026NCT07533006lastUpdatePostDate: changed
LOWJun 23, 2026NCT07533019lastUpdatePostDate: changed
LOWJun 23, 2026NCT07533006lastUpdatePostDate: changed
HIGHJun 23, 2026NCT06690996Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWJun 23, 2026NCT07533019lastUpdatePostDate: changed

Frequently asked questions about LY4005130

What is LY4005130 used for?

LY4005130 is an investigational small molecule being developed by Eli Lilly and Company for dermatology conditions. It is being studied in Phase 2 clinical trials for severe alopecia areata (hair loss) and non-segmental vitiligo. The drug is also being evaluated in a completed Phase 1 study in healthy participants.

What does LY4005130 target?

LY4005130 is a small molecule developed by Eli Lilly and Company. The specific molecular target of LY4005130 has not been disclosed in the available information. The drug is being investigated for its potential to treat alopecia areata and vitiligo, both of which are autoimmune-related skin conditions.

Who makes LY4005130?

LY4005130 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is currently in Phase 2 clinical development for dermatology indications including alopecia areata and vitiligo.

What phase is LY4005130 in?

LY4005130 is currently in Phase 2 clinical development. Eli Lilly and Company is conducting two Phase 2 trials for the drug, one in severe alopecia areata and another in non-segmental vitiligo. A Phase 1 study in healthy participants has been completed. LY4005130 is investigational and not yet approved.

What clinical trials is LY4005130 in?

LY4005130 is being studied in three clinical trials. NCT06690996 is a completed Phase 1 study in healthy participants. NCT07533006 is a recruiting Phase 2 trial in adults with severe alopecia areata. NCT07533019 is a recruiting Phase 2 trial in adults with non-segmental vitiligo. All trials are randomized, double-blind, and placebo-controlled.

Is LY4005130 FDA approved?

LY4005130 is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for alopecia areata and vitiligo, developed by Eli Lilly and Company. The drug has completed a Phase 1 study in healthy participants, but it remains in clinical development and has not received regulatory approval.