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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment169

FDA Designations

No designations recorded

Clinical trial landscape

ARRY-403, glucokinase activator · 2 trials · 1 indication

Phase 1 2
NCT00952198A Safety Study of ARRY-403 in Patients With Type 2 DiabetesType 2 Diabetes
COMPLETED128 Analytics
NCT00859755A Safety Study of ARRY-403 in Patients With Type 2 DiabetesType 2 Diabetes
COMPLETED41 Analytics
PHASE1COMPLETED
A Safety Study of ARRY-403 in Patients With Type 2 Diabetes
Type 2 DiabetesUnlock trial analytics
PHASE1COMPLETED
A Safety Study of ARRY-403 in Patients With Type 2 Diabetes
Type 2 DiabetesUnlock trial analytics

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 to 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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Frequently asked questions about ARRY-403, glucokinase activator

What is ARRY-403 used for in Type 2 Diabetes?

ARRY-403 is an investigational oral small molecule being studied for the treatment of Type 2 Diabetes. It was evaluated in Phase 1 clinical trials in adults with Type 2 Diabetes in the United States. It is not approved for any indication and remains in clinical development.

How does ARRY-403 work?

ARRY-403 is a glucokinase activator, a small molecule that acts on the glucokinase enzyme. Glucokinase plays a role in glucose sensing and regulation, and activating it is the intended mechanism for lowering blood glucose in Type 2 Diabetes. The drug is orally administered.

Who is developing ARRY-403?

ARRY-403 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 clinical studies of the compound in patients with Type 2 Diabetes.

What phase is ARRY-403 in?

ARRY-403 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for Type 2 Diabetes or any other indication.

What clinical trials is ARRY-403 in?

ARRY-403 has been studied in two completed Phase 1 trials: NCT00952198, which enrolled 128 patients with Type 2 Diabetes, and NCT00859755, which enrolled 41 patients with Type 2 Diabetes. Both were conducted in the United States in adults aged 18 years and older.

Is ARRY-403 the same as ARRY-403, glucokinase activator?

Yes. ARRY-403 and ARRY-403, glucokinase activator refer to the same investigational oral compound. The longer name describes its mechanism as a glucokinase activator, while ARRY-403 is the compound identifier used in its clinical trial listings for Type 2 Diabetes.