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TTP054

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 Enrollment186
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01665352A Study to Evaluate Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 DiabetesPHASE2 COMPLETED 186 — — Aug 1, 2012May 1, 2013Feb 10, 201719 United States
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Study Endpoints
Primary Endpoints
Change from baseline in HbA1c (%) as compared to placebo
Day 1 to Day 84
Secondary Endpoints
Change from baseline in fasting plasma glucose (mg/dL)
Day 1, Day 14, Day 28, Day 56 and Day 84
Subject achievement of HbA1c <7%
Day 84
Change from baseline in body weight
Day 1, Day 14, Day 28, Day 56 and Day 84
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TTP054 400 mgEXPERIMENTAL -
TTP054 200 mgEXPERIMENTAL -
TTP054 800 mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
TTP054DRUGAdministered orally once daily for 12 weeks.
PlaceboDRUGAdministered orally once daily for 12 weeks.
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Diagnosis of type 2 diabetes mellitus * On a stable (for the last 3 months) regimen of either metformin alone or metformin in combination with one additional acceptable oral antidiabetic (OAD) agent * HbA1c: Metformin only: 7.0 - 11.0%; Metformin + acceptable OAD agent: 6.5 - ...

Countries:United States
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