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LY4302814

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: May 5, 2026

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 Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07566338A Study of LY4302814 in Healthy ParticipantsPHASE1 NOT YET_RECRUITING 150May 1, 2026Aug 1, 2027May 5, 20262 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
Day 1 through Day 197
Secondary Endpoints
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4302814
Day 1 through Day 197
PK: Maximum Concentration (Cmax) of LY4302814
Day 1 through Day 197
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY4302814 IVEXPERIMENTALLY4302814 administered intravenously (IV)
Placebo IVPLACEBO_COMPARATORPlacebo administered IV
LY4302814 SCEXPERIMENTALLY4302814 administered subcutaneously (SC)
Placebo SCPLACEBO_COMPARATORPlacebo administered SC
Interventions
NameTypeDescription
LY4302814DRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Are overtly healthy as determined by medical evaluation. * Have clinical laboratory test results within the normal range for the population or investigative site or with abnormalities deemed not clinically significant by the investigator. * Have a body weight of 45 kilograms (...

Countries:United StatesSingapore
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07566338primaryCompletionDate: changed
LOWMay 24, 2026NCT07566338studyFirstPostDate: changed
LOWMay 21, 2026NCT07566338NEW_TRIAL: changed
LOWMay 21, 2026NCT07566338NEW_TRIAL: changed