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LY3541860

Phase 2

Undisclosed | Small molecule | Other |Eli Lilly and Company|Trials Updated: Apr 5, 2024

LY3541860 development status

Highest phase Phase 2 (NCT06859294)
Phase scored for LLYPhase 1
Registered trials 3 across 1 sponsor since Sep 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment94

FDA Designations

No designations recorded

LY3541860 clinical trials

LY3541860 · 1 trial · 1 indication

Phase 1 1
NCT05042310A Study of LY3541860 in Healthy Japanese and Non-Japanese ParticipantsHealthy
COMPLETED94 Analytics
PHASE1COMPLETED
A Study of LY3541860 in Healthy Japanese and Non-Japanese Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3541860
Predose on Day 1 through Day 113
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3541860
Predose on Day 1 through Day 113
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
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 either IV or SC.
PlaceboDRUGAdministered either IV or SC.
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Eligibility Criteria

Age Range20 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are male or female not of childbearing potential * Have a body weight between 18 and 32 kilograms per square meter (kg/m²) and a body weight ≥ 50 kilograms (kg) * Have veins suitable for blood sampling Exclusion Criteria: * Have or used to have health problems or laboratory ...

Countries:Japan
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Frequently asked questions about LY3541860

What is LY3541860?

LY3541860 is an investigational small molecule developed by Eli Lilly and Company. It has been studied in a Phase 1 clinical trial in healthy adult participants, including Japanese and non-Japanese volunteers. The specific disease or condition it is intended to treat has not been disclosed.

Who makes LY3541860?

LY3541860 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the Phase 1 study of the compound conducted in Japan.

What phase is LY3541860 in?

LY3541860 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational agent and has not been approved by the FDA for any indication.

What clinical trials is LY3541860 in?

LY3541860 has been evaluated in one completed Phase 1 trial, NCT05042310, titled A Study of LY3541860 in Healthy Japanese and Non-Japanese Participants. The trial enrolled 94 healthy volunteers in Japan, was randomized, double-blind, and placebo-controlled, and included participants aged 20 years and older.

What is LY3541860 used for?

LY3541860 has been studied only in healthy volunteers in a Phase 1 trial, so no therapeutic indication has been disclosed. It is an investigational small molecule and is not approved for any use. Its clinical development remains at the earliest stage.