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MBX-2044

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Gilead Sciences, Inc.|Last Updated: May 1, 2015

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 Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00422487Safety and Tolerability Study of MBX-2044 in Patients With Type 2 DiabetesPHASE2 COMPLETED 60Oct 1, 2006Sep 1, 2007May 1, 20151 United States
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Study Endpoints
Primary Endpoints
Evaluate the multiple-dose pharmacokinetics of MBX-2044 administered as monotherapy at the protocol-specified daily dose orally for 14 days
Evaluate the clinical safety and tolerability of MBX-2044 after 14 days administration, including the parameters of weight gain and edema
Determine the maximum tolerated dose (MTD) of MBX-2044, after 14 days administration
Determine the effect of MBX-2044 after 14 days administration, on efficacy parameters
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MBX-2044 1.5 mgEXPERIMENTAL -
MBX-2044 4.5 mgEXPERIMENTAL -
MBX-2044 15 mgEXPERIMENTAL -
MBX-2044 30 mgEXPERIMENTAL -
MBX-2044 60 mgEXPERIMENTAL -
MBX-2044 90 mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
MBX-2044DRUGMBX-2044 1.5 mg one capsule daily for 14 days
Placebo for MBX-2044DRUGPlacebo Intervention
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Type 2 diabetes previously controlled with up to one or two non-TZD hypoglycemic agents including sulfonylureas (e.g., glyburide, glipizide, glimeprimide), meglitinides (e.g., Prandin®, Starlix®), metformin (e.g., Glucophage®), α-glucosidase inhibitors (e.g.,acarbose, miglitol...

Countries:United States
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