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GSK1521498

Phase 2

Obesity | Small molecule | Metabolic |GSK plc|Last Updated: Dec 1, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01195792A 35 Day Study to Investigate the Effects of GSK1521498 on Bodyweight in Obese Subjects With Over-Eating Behaviours.PHASE2 COMPLETED 60Sep 1, 2010May 1, 2011Dec 1, 20163 United Kingdom
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Study Endpoints
Primary Endpoints
Clinically and statistically significant weight loss
35 days
Secondary Endpoints
To see if effects on bodyweight are associated with effects on fat mass, eating behaviour brain function and blood and urine markers
35 days
To see if effects on bodyweight correlate with over-eating behaviour at baseline
35 days
Safety: adverse events,blood pressure, heart rate, ECG, clinical chemistry, hematology, urinalysis, change in cognition (eg reaction times), change in mood scales, change in neuropsychiatric symptoms
35 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
2 mg GSK1521498EXPERIMENTALApproximately 20 subjects will be randomised to receive 2 mg GSK1521498. The drug is being developed for the treatment of obesity due to excessive consumption of high calorie foods
5 mg GSK1521498EXPERIMENTALApproximately 20 subjects will be randomised to receive 5 mg GSK1521498. The drug is being developed for the treatment of obesity due to excessive consumption of high calorie foods
PlaceboPLACEBO_COMPARATORApproximately 20 subjects will be randomised to receive matching placebo.
Interventions
NameTypeDescription
GSK1521498DRUGGSK1521498 2mg or 5mg will be given for up to 35 days and subjects will be assessed weekly
PlaceboDRUGPlacebo will be given for up to 35 days and subjects will be assessed weekly
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Obese but essentially healthy male or female between 18 and 60 years of age inclusive. * Body Mass Index greater than or equal to 30 kg/m2. * Binge Eating Scale (BES) score that is greater than or equal to 19 at screening assessment. * A female subject of child-bearing potenti...

Countries:United Kingdom
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