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MK0557

Phase 3

Obesity | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Jan 2, 2017

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-BlindUNCONTROLLED
Total Trials4
Total Enrollment2,356
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00092872A 1-Year Study of an Investigational Drug in Obese Patients (0557-012)(COMPLETED)PHASE3 COMPLETED 359Nov 1, 2003Feb 1, 2005Jan 30, 2015 -
NCT00092859A 2-Year Study of an Investigational Drug in Obese Patients (0557-011)PHASE3 COMPLETED 1,500Aug 1, 2003Jun 1, 2005Jan 2, 2017 -
NCT00533481Efficacy of MK0557 in Combination With Sibutramine or Orlistat (0557-015)(COMPLETED)PHASE2 COMPLETED 497Feb 1, 2004Dec 1, 2004Sep 16, 2016 -
NCT00533598A Study to Determine the Effects of MK0557 in Obese Subjects (0557-006)(COMPLETED)PHASE2 COMPLETED -Sep 1, 2002Jun 1, 2003Sep 7, 2016 -
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Study Endpoints
Primary Endpoints
Body weight after 1 year of treatment.
After 1 year of treatment
Safety and tolerability.
After 1 year of treatment
Body weight after 1 year of treatment. Safety and tolerability for 2 years.
After 1 & 2 years of treatment
Secondary Endpoints
Waist circumference; Blood pressure, body fat mass, biochemical markers (fasting plasma, lipid profile, fasting plasma glucose, leptin, insulin, insulin sensitivity); body weight after 2 years
After 2 years
Durability of weight loss over two years.
Over two years.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
MK0557DRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Obese men and nonpregnant women between the ages of 18 and 65 years with a body mass index (height to weight ratio) as required by the study. Exclusion Criteria: * Patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)

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