In short
LY4005130 is an investigational protein-based substance being developed by Eli Lilly and Company for the treatment of autoimmune conditions affecting the skin and hair. It is currently being studied in two Phase 2 clinical trials involving adults with non-segmental vitiligo and severe alopecia areata. The trials, which are authorised but not yet recruiting, will involve a total of 131 participants across both studies.
Key points
- LY4005130 is an investigational protein-based substance with no marketing authorisation.
- It is being studied in two Phase 2 trials for non-segmental vitiligo and severe alopecia areata.
- The vitiligo trial will enrol 66 participants; the alopecia areata trial will enrol 65 participants.
- Both trials compare LY4005130 given intravenously against a placebo.
- The vitiligo trial measures the Facial Vitiligo Area Scoring Index (F-VASI) 75; the alopecia trial measures the Severity of Alopecia Tool (SALT) ≤20.
- Both trials are currently authorised in the EU Clinical Trials Information System.
What is LY4005130?
LY4005130 is an investigational protein-based substance being developed by Eli Lilly and Company Limited. It is classified in the therapeutic area of immune system diseases, specifically under the category of immune system disorders. The substance has no marketing authorisation in the product records, meaning it is still in the research phase and has not been approved as a medicine. LY4005130 is a protein of the type "Protein - Other", which indicates it is a protein-based therapeutic rather than a small chemical molecule.
How does LY4005130 work?
The exact mechanism of action of LY4005130 is not described in the available registry data or supplementary sources. What is known is that it is being investigated for conditions in which the immune system attacks the body's own tissues — non-segmental vitiligo, where the immune system targets pigment-producing cells in the skin, and severe alopecia areata, where it attacks hair follicles. As a protein-based substance given intravenously, it is likely designed to modulate or suppress a specific part of the immune response involved in these autoimmune processes, but the precise molecular target has not been disclosed in the sources provided.
Which conditions is LY4005130 studied for?
LY4005130 is being studied in two autoimmune conditions affecting the skin and hair:
- Non-segmental vitiligo (NSV) — a condition in which the immune system destroys melanocytes, the cells that produce skin pigment, leading to patches of skin losing their colour. The vitiligo trial focuses on facial involvement.
- Severe alopecia areata — an autoimmune condition in which the immune system attacks hair follicles, causing patchy or complete hair loss. The trial specifically targets participants with severe forms of the disease.
How is LY4005130 given?
LY4005130 is formulated as a solution for injection and is administered by intravenous use, meaning it is given directly into a vein. In both clinical trials, the intervention is listed as LY4005130 with a dose of 0 mg, which indicates that the specific dose has not been reported in the registry records. The trials also include a comparator intervention identified as SUB12581MIG, which serves as the placebo arm for comparison.
What do the clinical trials show?
LY4005130 is currently being investigated in two Phase 2 clinical trials authorised in the EU Clinical Trials Information System (CTIS). Both trials are interventional, randomised, multicentre, double-blind, and placebo-controlled, designed as proof-of-concept studies to compare the efficacy and safety of LY4005130 against placebo.
The first trial (EU CT number 2025-524726-18-00) is studying LY4005130 in 66 adult participants with non-segmental vitiligo. The primary outcome measure is the percentage of participants achieving F-VASI 75, which stands for a 75% improvement in the Facial Vitiligo Area Scoring Index — a scale that measures the extent and severity of vitiligo on the face.
The second trial (EU CT number 2025-524727-41-00) is studying LY4005130 in 65 adult participants with severe alopecia areata. The primary outcome measure is the percentage of participants achieving a Severity of Alopecia Tool (SALT) score of 20 or less, which indicates that 80% or more of the scalp hair has regrown.
Both trials are currently in the authorised status, meaning they have received regulatory approval to proceed but have not yet begun recruiting participants. The alopecia areata trial is described in the supplementary source as having a recruiting status, with a planned primary completion date in 2027.
What side effects are known?
The available sources do not provide specific information about side effects associated with LY4005130. As an investigational substance in Phase 2 trials, its safety profile is still being evaluated. The clinical trials are designed to investigate both efficacy and safety, but no adverse event data has been published in the provided registry records or supplementary sources.