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LY4515100 via SAD

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Mar 2, 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 Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07339722A Study of LY4515100 in Healthy ParticipantsPHASE1 RECRUITING 40Jan 15, 2026Jul 1, 2026Mar 2, 20261 United States
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Study Endpoints
Primary Endpoints
Number of participants with one or more serious adverse event(s) (SAEs) of LY4515100
Day 1 up to Day 30

SAEs of LY4515100

Secondary Endpoints
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY4515100
Day 1 through Day 11
PK: Maximum Observed Drug Concentration (Cmax) of LY4515100
Time Frame: Day 1 through Day 11
PK: Time of maximum observed drug concentration (tmax) of LY4515100
Day 1 through Day 11
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY4515100 of Part A (SAD)EXPERIMENTALSingle-ascending doses of LY4515100 will be given orally
LY4515100 of Part B (MAD)EXPERIMENTALMultiple-ascending doses of LY4515100 will be given orally
Placebo Part APLACEBO_COMPARATORPlacebo will be given orally
Placebo Part BPLACEBO_COMPARATORPlacebo will be given orally
Interventions
NameTypeDescription
LY4515100 via SADDRUGgiven orally
LY4515100 via MADDRUGgiven orally
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring. * Have a body mass index within the range of 18.5 to 32.0 kilograms per square meter (kg/m\^2) (inclusive). * Individ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07339722primaryCompletionDate: changed
LOWMay 24, 2026NCT07339722studyFirstPostDate: changed