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GW590735

Phase 2

Dyslipidaemias | Small molecule | Metabolic |GSK plc|Last Updated: Oct 22, 2012

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_CONTROLLED
Total Trials1
Total Enrollment250
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00169559Dyslipidemia Study Investigating The Increase In "Good Cholesterol"PHASE2 COMPLETED 250 — — Nov 1, 2003Apr 1, 2005Oct 22, 201250 United States, Canada
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Study Endpoints
Primary Endpoints
change from baseline in fasting plasma HDLc concentration at the end of eight weeks of double blind treatment
8 weeks
Secondary Endpoints
changes from baseline in: fasting plasma total cholesterol, TG, LDLc, ApoA1, ApoA2, Lipoprotein containing ApoA1 and not ApoA2, Lipoprotein containing both ApoA1 and ApoA2, Apo B100, Apo CIII, Free Fatty Acid, insulin, fibrinogen, and C-reactive protein
8 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1PLACEBO_COMPARATORPlacebo
Arm 2ACTIVE_COMPARATORFenofibrate
Interventions
NameTypeDescription
GW590735DRUG1µg to 20µg daily doses of GW590735
fenofibrateDRUGMarketed Drug
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites50

Inclusion criteria: * High-density lipoprotein cholesterol less than or equal to 45 mg/dL. * Triglycerides greater than or equal to 120 mg/dL and less than or equal to 500 mg/dL. * Women must be surgically sterile or postmenopausal. Exclusion criteria: * Heart disease * Diabetes

Countries:United StatesCanada
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