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MB07803

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Ligand Pharmaceuticals Incorporated|Last Updated: Oct 3, 2011

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 Enrollment105
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00458016Safety, Tolerability, and Efficacy Study of MB07803 Administered to Patients With Type 2 Diabetes MellitusPHASE2 COMPLETED 105Mar 1, 2007Mar 1, 2008Oct 3, 201125 United States
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Study Endpoints
Primary Endpoints
Fasting Plasma Glucose Concentration
Change from baseline to Day 28
Secondary Endpoints
Fasting serum triglycerides and free fatty acids, fasting serum insulin.
Change from baseline to Day 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4EXPERIMENTAL -
5PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
MB07803DRUGDaily oral administration
PlaceboDRUGDaily oral administration
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Fasting plasma glucose between 120 - 270 mg/dL at screening * HbA1c measurements between 6.0 - 10% at screening * Females who are surgically sterile (i.e. women who have had a hysterectomy or tubal ligation). Females who are postmenopausal for at least 12 consecutive months an...

Countries:United States
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