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LY900020

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Mar 3, 2020

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04047940A Study of LY900020 in Healthy Chinese ParticipantsPHASE1 COMPLETED 32Nov 29, 2019Feb 18, 2020Mar 3, 20201 Singapore
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Study Endpoints
Primary Endpoints
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY900020
Predose through 72 hours postdose on Day 4 in each study arm

PK: AUC of LY900020

PK: Maximum Observed Drug Concentration (Cmax) of LY900020
Predose through 72 hours postdose on Day 4 in each study arm

PK: Cmax of LY900020

Secondary Endpoints
PK: Time to Maximum Observed Drug Concentration (tmax) of LY900020
Predose through 72 hours postdose on Day 4 in each study arm
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY900020 Formulation 1EXPERIMENTALLY900020 Formulation 1 administered orally
LY900020 Formulation 2EXPERIMENTALLY900020 Formulation 2 administered orally
LY900020 Formulation 3EXPERIMENTALLY900020 Formulation 3 administered orally
Reference DrugsACTIVE_COMPARATORMetformin XR, atorvastatin, and valsartan administered orally
Interventions
NameTypeDescription
LY900020DRUGAdministered orally
Metformin XRDRUGAdministered orally
AtorvastatinDRUGAdministered orally
ValsartanDRUGAdministered orally
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Eligibility Criteria
Age Range21 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until study completion) * Have a body mass index (BMI) of 18.5 to 35 kilogram per square meter (kg/m²), inclusive, at screening * Have normal blood pressure, pulse rate, electrocardiogr...

Countries:Singapore
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