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TTP273

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |vTv Therapeutics Inc.|Last Updated: Feb 10, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment174
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02653599A Study to Evaluate Safety and Efficacy of TTP273 for 12 Weeks in Subjects With Type 2 DiabetesPHASE2 COMPLETED 174Dec 1, 2015Jan 1, 2017Feb 10, 201730 United States
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Study Endpoints
Primary Endpoints
Change in HbA1c from baseline at 12 weeks
Day 1 to Week 12
Secondary Endpoints
Percentage of subjects who achieve HbA1c <7% at 12 weeks
Day 1 to Week 12
Change in body weight from baseline at 12 weeks
Day 1 to Week 12
Change in plasma glucose levels from baseline at 12 weeks
Day 1 to Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TTP273 300 mg daily (150 mg BID)EXPERIMENTALTwo 75 mg tablets of TTP273 administered orally twice daily for 12 weeks
TTP273 150 mg dailyEXPERIMENTALTwo 75mg tablets of TTP273 administered orally once daily and two placebo tablets administered orally once daily for 12 weeks
PlaceboPLACEBO_COMPARATORTwo matching placebo tablets administered orally twice daily for 12 weeks
Interventions
NameTypeDescription
TTP273DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites30

Inclusion Criteria: * The subject has a 6 month diagnosis of Type 2 diabetes mellitus prior to screening and meets the American Diabetes Association (ADA) guidelines for Type 2 diabetes mellitus. * On a stable regimen of metformin monotherapy equivalent to at least 1000 mg/day for the last 3 months...

Countries:United States
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