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TTP054

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |vTv Therapeutics Inc.|Last Updated: Feb 10, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment186

FDA Designations

No designations recorded

Clinical trial landscape

TTP054 · 1 trial · 1 indication

Phase 2 1
NCT01665352A Study to Evaluate Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 DiabetesType 2 Diabetes Mellitus
COMPLETED186 Analytics
PHASE2COMPLETED
A Study to Evaluate Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes
Type 2 Diabetes Mellitus
NCT01665352186
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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 to 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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Frequently asked questions about TTP054

What is TTP054 used for?

TTP054 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is intended to address the metabolic condition, though its exact mechanism of action has not been disclosed.

Who makes TTP054?

TTP054 is being developed by vTv Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VTVT. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Type 2 Diabetes Mellitus.

What phase is TTP054 in?

TTP054 is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational, meaning it is not yet approved for commercial use. The completed study evaluated the drug's safety and efficacy over 12 weeks in patients with Type 2 Diabetes Mellitus.

What clinical trials is TTP054 in?

TTP054 has one completed Phase 2 clinical trial registered as NCT01665352. This randomized, double-blind, placebo-controlled study enrolled 186 participants with Type 2 Diabetes Mellitus in the United States. The trial evaluated the safety and efficacy of TTP054 over a 12-week treatment period.

Is TTP054 FDA approved?

No, TTP054 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The completed Phase 2 trial (NCT01665352) assessed its safety and efficacy in Type 2 Diabetes Mellitus, but the drug has not yet received regulatory approval for any indication.

Is TTP054 a small molecule?

Yes, TTP054 is a small molecule therapeutic. It is being developed as an oral treatment for Type 2 Diabetes Mellitus. The drug is currently in Phase 2 clinical trials, with one completed study evaluating its effects in patients with the condition.