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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?

ARRY-403 is an investigational small molecule being developed for the treatment of Type 2 Diabetes. It is a glucokinase activator, a class of drugs that targets the enzyme glucokinase to help regulate blood sugar levels. The drug is currently in Phase 1 clinical development.

What does ARRY-403 target?

ARRY-403 targets glucokinase, an enzyme that plays a key role in glucose sensing and metabolism. By activating glucokinase, the drug aims to enhance glucose uptake and insulin secretion, which may help control blood sugar in patients with Type 2 Diabetes.

Who makes ARRY-403?

ARRY-403 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical trials for Type 2 Diabetes.

What phase is ARRY-403 in?

ARRY-403 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both focusing on safety in patients with Type 2 Diabetes.

What clinical trials is ARRY-403 in?

ARRY-403 has been studied in two completed Phase 1 clinical trials: NCT00859755 and NCT00952198. Both were safety studies in patients with Type 2 Diabetes, conducted in the United States, with a combined enrollment of 169 participants.

Is ARRY-403 the same as a glucokinase activator?

Yes, ARRY-403 is a glucokinase activator. This means it works by activating the glucokinase enzyme, which is involved in glucose metabolism. This mechanism is being investigated for its potential to treat Type 2 Diabetes.