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Comparator: sibutramine

Phase 1

Obesity | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Oct 12, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00914212A Functional Magnetic Resonance Imaging (fMRI) Study in Overweight and Obese Men (0000-103)PHASE1 COMPLETED 15May 1, 2009Aug 1, 2009Oct 12, 2015 -
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Study Endpoints
Primary Endpoints
Average percent signal change of the top 20% of activated voxels (AvgPSC20) during the fasted condition over six primary brain regions of interest (ROI)
Day 1
Secondary Endpoints
Intraclass coefficient of correlation of the AvgPSC20 assessed during the fed and fasted conditions over the six ROIs
Day 1
Regional cerebral blood flow (rCBF) during the fasted condition with placebo or sibutramine in the six ROIs
Day 1
AvgPSC20 in the fed condition with placebo or sibutramine in the six ROIs
Day 1
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORSibutramine
2PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
PlaceboDRUGSingle dose placebo to sibutramine in two of three treatment periods.
Comparator: sibutramineDRUGSingle dose sibutramine 30 mg (2 x 15 mg) in one of three treatment periods.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Subject is a male between 18 and 45 years of age * Subject has a body mass index (BMI) between 28 and 35 kg/m\^2 * Subject does not weigh more than 140 kg (309 lbs) at the screening visit * Subject is right-handed * Subject is a non-smoker * Subject is in generally good health...

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