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LY3478045

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Jul 25, 2024

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 Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04270370A Study of LY3478045 in Healthy ParticipantsPHASE1 COMPLETED 72 — — Mar 16, 2020Jun 23, 2021Jul 25, 20241 United States
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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 Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is reported in the Reported Adverse Events module.

Secondary Endpoints
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3478045
Part A: Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 95 hours post dose; Part B: Day 1: Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16 and 24 hours post dose; Day 14: Predose ,0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose
PK: Maximum Concentration (Cmax) of LY3478045
Part A: Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 95 hours post dose; Part B: Day 1: Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16 and 24 hours post dose; Day 14: Predose ,0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3478045 (Part A)EXPERIMENTALParticipants received single ascending oral dose of 20 milligram (mg), 60mg, 180 mg, 500 mg, 700 mg LY3478045 on Day 1.
Placebo (Part A)PLACEBO_COMPARATORParticipants received single oral dose of placebo on Day 1.
LY3478045 (Part B)EXPERIMENTALParticipants received multiple ascending oral dose of 60mg and 300 mg LY3478045 once-daily (QD)for 14 days.
Placebo (Part B)PLACEBO_COMPARATORParticipants received oral dose of placebo QD for 14 days.
LY3478045 + Atorvastatin (Part B)EXPERIMENTALParticipants received multiple ascending oral doses of 160 mg, 360 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
Placebo + Atorvastatin (Part B)PLACEBO_COMPARATORParticipants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
Interventions
NameTypeDescription
LY3478045DRUGAdministered orally.
PlaceboDRUGAdministered orally.
AtorvastatinDRUGAdministered orally.
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are overtly healthy participants as determined through medical history and physical examination * Have a body mass index greater than or equal to (≥)18.5 and less than or equal to (≤)40 kilograms per square meter (kg/m²) * Have had a stable weight for 3 months prior to screeni...

Countries:United States
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