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LY3541860

Phase 2

Multiple Sclerosis | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Apr 7, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment63
FDA Designations
No designations recorded
Clinical trial landscape

LY3541860 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT06220669A Study of LY3541860 in Adult Participants With Relapsing Multiple SclerosisMultiple Sclerosis
ACTIVE NOT_RECRUITING63 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis
Multiple SclerosisUnlock trial analytics
Study Endpoints
Primary Endpoints
Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions
12 Weeks

Cumulative number will be measured by magnetic resonance imaging (MRI) scans.

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 through Day 113

A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Endpoints
Cumulative Number of Total Number of T1 GdE Lesions
12 Weeks
Cumulative Number of New and/or Enlarging T2 Lesions
12 Weeks
Pharmacokinetics (PK): Plasma Trough Concentrations of LY3541860
Baseline Through Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY3541860 Phase 2a Dose Level 1EXPERIMENTALLY3541860 will be given intravenously (IV)
LY3541860 Phase 2a Dose Level 2EXPERIMENTALLY3541860 will be given IV.
Placebo Phase 2aPLACEBO_COMPARATORPlacebo will be given IV.
LY3541860 Phase 2b Dose Level 3EXPERIMENTALLY3541860 will be given IV.
LY3541860 Phase 2b Dose Level 4EXPERIMENTALLY3541860 will be given IV.
Placebo Phase 2bPLACEBO_COMPARATORPlacebo will be given IV.
LY3541860 (Part A)EXPERIMENTALSingle doses of LY3541860 administered intravenously (IV) or subcutaneously (SC).
LY3541860 (Part B)EXPERIMENTALMultiple doses of LY3541860 administered either IV or SC.
Placebo (Part A)PLACEBO_COMPARATORSingle doses of Placebo administered either IV or SC.
Placebo (Part B)PLACEBO_COMPARATORMultiple doses of Placebo administered either IV or SC.
Interventions
NameTypeDescription
LY3541860DRUGAdministered IV
PlaceboDRUGAdministered IV
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Eligibility Criteria
Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Participants must meet criteria for relapsing forms of multiple sclerosis, including relapsing-remitting multiple sclerosis based on the 2017 revision of the McDonald diagnostic criteria (Thompson et al. 2018) with a relapsing course (RMS) activity according to Klineova and Lu...

Countries:United StatesFranceItalyLatviaPolandSlovakiaUnited KingdomJapan
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Recent Changes (Last 90 Days)
HIGHMay 26, 2026NCT06220669Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT06220669studyFirstPostDate: changed