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GW501516

Phase 2

Dyslipidaemias | Small molecule | Metabolic |GSK plc|Last Updated: May 30, 2017

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment424
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00158899GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein CholesterolPHASE2 COMPLETED 424 — — Aug 1, 2004Jun 1, 2006May 30, 201764 Belgium, Denmark +9
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Study Endpoints
Primary Endpoints
The change from baseline in fasting plasma HDLc concentration at the end of 12 weeks of double-blind treatment.
12 Weeks
Secondary Endpoints
Changes from baseline at the end of 12 weeks of double-blind treatment of total cholesterol and other lipid parameters. Population pharmacokinetic parameters including oral clearance and apparent volume of distribution of GW501516.
12 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
GW501516 oral tabletsDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites64

Inclusion criteria: * Have a fasting plasma HDLc concentration \<=45mg/dL (\<=1.16mmol/L), plasma LDLc levels that do not require treatment according to the National Cholesterol Education Program/Adult Treatment Panel III (NCEP/ATPÂ III) guidelines. * Have a fasting plasma TG concentration =500mg/d...

Countries:BelgiumDenmarkEstoniaFinlandFranceGermanyLithuaniaNetherlandsNorwayPortugalSweden
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