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MBX-2982

Phase 2

Diabetes | Small molecule | Metabolic |Gilead Sciences, Inc.|Last Updated: Apr 17, 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_CONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01035879Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of MBX-2982 Administered Daily for 4 Weeks as Monotherapy in Patients With Type 2 DiabetesPHASE2 COMPLETED 100Dec 1, 2009Aug 1, 2010Apr 17, 201514 United States, Georgia +1
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Study Endpoints
Primary Endpoints
Evaluate the effect of MBX-2982 on the absolute and percent change from baseline and placebo in mean weighted average of 14-point blood glucose levels associated with a standardized breakfast and lunch
4 weeks
Secondary Endpoints
Evaluate the effect of MBX-2982 on additional glycemic parameters.
4 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MBX-2982 25 mgEXPERIMENTAL -
MBX-2982 100 mgEXPERIMENTAL -
MBX-2982 300 mgEXPERIMENTAL -
Sitagliptin 100 mgACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
MBX-2982DRUGtablets and capsule once daily
SitagliptinDRUGtablets and capsule once daily
placeboDRUGtablets and capsule once daily
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * History of type 2 diabetes of at least 3 months duration * Treatment-naïve (not on any anti-diabetic medication) or treated with a single anti-diabetic agent (excluding insulin, exenatide or other GLP-1 analogs, pioglitazone or rosiglitazone) * HbA1c 7.0-8.5% (inclusive) at sc...

Countries:United StatesGeorgiaIndia
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