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LY3540378

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Jun 21, 2022

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment134

FDA Designations

No designations recorded

Clinical trial landscape

LY3540378 · 1 trial · 1 indication

Phase 1 1
NCT04768855A Study of LY3540378 in Healthy ParticipantsHealthy
COMPLETED134 Analytics
PHASE1COMPLETED
A Study of LY3540378 in Healthy Participants
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Study Endpoints

Primary Endpoints

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline up to Day 113

A summary of 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 LY3540378
Predose on Day 1 through Day 113
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3540378
Predose on Day 1 through Day 113
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3540378 (Part A)EXPERIMENTALSingle ascending doses of LY3540378 administered either intravenously (IV) or subcutaneously (SC).
LY3540378 (Part B)EXPERIMENTALMultiple ascending doses of LY3540378 administered SC.
LY3540378 (Part C)EXPERIMENTALMultiple ascending doses of LY3540378 administered SC in Japanese Participants.
LY3540378 (Part D)EXPERIMENTALMultiple ascending doses of LY3540378 administered SC in Chinese Participants.
Placebo (Part A, B, C & D)PLACEBO_COMPARATORPlacebo administered either IV or SC.

Interventions

NameTypeDescription
LY3540378DRUGAdministered IV or SC.
PlaceboDRUGAdministered IV or SC.
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Eligibility Criteria

Age Range21 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Overtly healthy males or females, as determined by medical history and physical examination. * Body mass index (BMI) within the range of 19 to 30 kilograms per meter squared (kg/m²) * For Part C, participants should be first generation Japanese origin. * For Part D, participan...

Countries:United StatesSingapore
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Frequently asked questions about LY3540378

What is LY3540378?

LY3540378 is an investigational small molecule being developed by Eli Lilly and Company. It is currently in Phase 1 clinical development, studied in healthy participants. The drug is not approved and remains under investigation.

What is LY3540378 used for?

LY3540378 is being studied in healthy participants as part of early clinical development. Its intended therapeutic use has not been established, as it is still in Phase 1 trials.

Who makes LY3540378?

LY3540378 is developed by Eli Lilly and Company, a biopharmaceutical company traded on the stock exchange under the ticker LLY.

What phase is LY3540378 in?

LY3540378 is in Phase 1 clinical development. A Phase 1 study in healthy participants has been completed, and the drug remains investigational.

What clinical trials is LY3540378 in?

LY3540378 has one completed Phase 1 trial, NCT04768855, titled "A Study of LY3540378 in Healthy Participants." The trial enrolled 134 participants in the United States and Singapore.

Is LY3540378 FDA approved?

LY3540378 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development, with a completed study in healthy participants.