Recent Updates
Recently added Catalysts

LY3541860

Phase 2

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about LY3541860

What is LY3541860 used for?

LY3541860 is an investigational small molecule being studied for use in healthy participants and in adults with relapsing multiple sclerosis. It is currently in clinical development and has not been approved by regulatory authorities.

Who is developing LY3541860?

LY3541860 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY.

What phase is LY3541860 in?

LY3541860 is in clinical development. A Phase 1 study in healthy participants has been completed, and a Phase 2 study in adults with relapsing multiple sclerosis is active but not recruiting participants.

What clinical trials is LY3541860 in?

LY3541860 has been studied in two clinical trials. NCT05042310 was a completed Phase 1 study in healthy Japanese and non-Japanese participants. NCT06220669 is an active Phase 2 study in adults with relapsing multiple sclerosis.

Is LY3541860 being studied in multiple sclerosis?

Yes, LY3541860 is being studied in adults with relapsing multiple sclerosis in a Phase 2 clinical trial. The trial is active but not recruiting participants and is being conducted in the United States, France, Italy, Latvia, Poland, Slovakia, and the United Kingdom.