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GW677954

Phase 2

Metabolic Syndrome X | Small molecule | Metabolic |GSK plc|Last Updated: Oct 28, 2016

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment290
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00264667Study In Patients With DyslipidaemiaPHASE2 COMPLETED 290Dec 1, 2005Jun 1, 2007Oct 28, 201650 Argentina, Australia +11
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Study Endpoints
Primary Endpoints
Percentage change from baseline in non-HDL-C based on log-transformed data at week 24.
Secondary Endpoints
Percentage change from baseline in lipids, in Homeostasis Model Assessment-insulin sensitivity (HOMA-S), C-Reactive Protein (CRP), Fasting Plasma Glucose (FPG), body weight and waist circumference.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
GW677954DRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites50

Inclusion Criteria: * Waist circumference =102cm (men) or =88cm (women) at visit 1. * Fasting plasma HDL C =40mg/dL (1.03mmol/L) (men) or =50mg/dL (1.29mmol/L) (women) at Screening Visit 1. * Fasting TGs =150mg/dL (1.69mmol/L) and =800mg/dL (8.96mmol/L) at Screening Visit 1. * Subjects whose plasma...

Countries:ArgentinaAustraliaChileCosta RicaIndiaLatviaMexicoNew ZealandPakistanRomaniaRussiaSlovakiaSpain
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