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Evacetrapib

Phase 1

Dyslipidemia | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Oct 3, 2018

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment101
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02168803A Study of Evacetrapib in Participants With Abnormal CholesterolPHASE1 COMPLETED 101May 1, 2014Dec 1, 2015Oct 3, 20183 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics (PK) Parameters of Evacetrapib: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast])
Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
PK Parameters of Evacetrapib: Maximum Concentration (Cmax)
Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
PK Parameters of Evacetrapib: Terminal Half-life
Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
Secondary Endpoints
PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level
Day -1, Day 8
PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level
Day -1, Day 8
PD Parameters of Evacetrapib: Total Cholesterol Level
Day -1, Day 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Evacetrapib: Single DoseEXPERIMENTALSingle oral dose of evacetrapib on Day 1
Evacetrapib: Multiple Dose 12 WeeksEXPERIMENTALEvacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks
Evacetrapib: Multiple Dose 24 WeeksEXPERIMENTALEvacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks
Evacetrapib: Multiple Dose 52 WeeksEXPERIMENTALEvacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks
Interventions
NameTypeDescription
EvacetrapibDRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Generally healthy participants or have stable medical conditions that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpret...

Countries:United States
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