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SR147778

Phase 2

Obesity | Small molecule | Metabolic |Sanofi|Last Updated: Dec 10, 2008

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 Enrollment394
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00239174A Multicenter Study to Evaluate the Efficacy and Safety of of Four Doses of SR147778 in Obese PatientsPHASE2 COMPLETED 394Nov 1, 2004Nov 1, 2005Dec 10, 20085 Argentina, Australia +3
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Study Endpoints
Primary Endpoints
Weight loss at 6 months.
Secondary Endpoints
Waist circumference,lipid parameters,glycemic parameters,metabolic syndrome,blood pressure,adipokines,CRP,IL-6,IL-2,patient satisfaction,food behavior,daily caloric intake, and dietary compliance at 6 months.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
SR147778DRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Patients must voluntarily sign the informed consent, * Patients must be male or female and aged 18 to 65 years, * Patients must be able to follow verbal and written instructions, * Female patients of childbearing potential (pre-menopausal women) must have a confirmed negative ...

Countries:ArgentinaAustraliaFinlandFranceSpain
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