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LY3540378

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment134
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04768855A Study of LY3540378 in Healthy ParticipantsPHASE1 COMPLETED 134Mar 17, 2021May 30, 2022Jun 21, 20222 United States, Singapore
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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 — 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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