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GW869682

Phase 2

Obesity | Small molecule | Metabolic |GSK plc|Last Updated: Apr 15, 2015

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 Enrollment136
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00297180Weight Loss In Obese Subjects Taking Either GW869682 Or Placebo 3 Times Per Day For 12 WeeksPHASE2 COMPLETED 136Jan 1, 2006Sep 1, 2006Apr 15, 20153 United States
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Study Endpoints
Primary Endpoints
Percentage change in body weight from baseline to Week 12.
from baseline to Week 12.
Secondary Endpoints
Blood levels of GW869682 at the Week 2 and Week 11.
at the Week 2 and Week 11
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
GW869682DRUG -
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion criteria: * Have a BMI within range 30.0 to 40.0kg/m2, inclusive. * Females who meet above criteria must be physiologically incapable of becoming pregnant (ie., surgically sterilized, or post-menopausal per protocol definition). Exclusion criteria: * History of eating disorders. * Recen...

Countries:United States
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