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ARRY-403, glucokinase activator;

Phase 1

Type 2 Diabetes | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Oct 6, 2020

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 Trials2
Total Enrollment169
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00952198A Safety Study of ARRY-403 in Patients With Type 2 DiabetesPHASE1 COMPLETED 128 — — Aug 1, 2009Aug 1, 2010Oct 6, 20202 United States
NCT00859755A Safety Study of ARRY-403 in Patients With Type 2 DiabetesPHASE1 COMPLETED 41 — — Mar 1, 2009 -Aug 30, 20121 United States
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Study Endpoints
Primary Endpoints
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
Duration of study
Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations.
10 days
Secondary Endpoints
Assess the effect of study drug on glycemic control as determined by an oral glucose tolerance test (OGTT).
10 days
Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.
10 days
Assess the ability of the study drug to improve glucose tolerance as determined by blood glucose monitoring during a standardized meal challenge.
Day 1, Day 2
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARRY-403EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ARRY-403, glucokinase activator; oralDRUGmultiple dose, escalating
Placebo; oralDRUGmatching placebo
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites2

Key Inclusion Criteria: * Male or female (females must be of non-childbearing potential), between the ages of 18 and 70 years, inclusive. * Diagnosis of Type 2 diabetes. * Fasted C-peptide value ≥ 0.8 ng/mL. * HbA1c ≥ 6.5% and ≤ 10.0% for monotherapy cohorts (study drug only) or HbA1c ≥ 7.5% and ≤ ...

Countries:United States
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