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TTP435

Phase 2

Obesity | Small molecule | Metabolic |vTv Therapeutics Inc.|Last Updated: Jun 27, 2011

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_CONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00779519Safety Study of the Inhibition of Agouti-related Protein (AgRP) for the Management of Obesity and Weight LossPHASE2 COMPLETED 100Feb 1, 2009 -Jun 27, 201112 United States, Canada
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Study Endpoints
Primary Endpoints
Participant Adverse Events
Day 1 to Day 70 (2 weeks post dose)
Secondary Endpoints
Change from Baseline Glucose Levels
Day 1 to Day 70 (2 weeks post dose)
Absolute Change in Body Weight
Day 1 to Day 70 (2 weeks post dose)
Absolute Change in Body Mass Index
Day 1 to Day 70 (2 weeks post dose)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
TTP435EXPERIMENTAL -
Interventions
NameTypeDescription
TTP435DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites12

Inclusion Criteria: * Male or female volunteers, aged 18 to 65 years, inclusive. * Subjects must be obese (class 1: BMI of 30.0 to 34.9 kg/m2 or class 2: BMI of 35 to 39.9 kg/m2 in non-Asians and BMI of 27.0 - 31.9 kg/m2 or 32.0 - 36.9 kg/m2 in Asians) at the Screening Visit. * Female subjects must...

Countries:United StatesCanada
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