A model‐informed approach to accelerate the clinical development of cofrogliptin (HSK7653), a novel ultralong‐acting dipeptidyl peptidase‐4 inhibitor
Cheng Cui,
Fangrui Cao,
Iok Ian Kong
et al.
Abstract:AimTo employ a model‐informed drug development approach in facilitating decision making and expediting the clinical progress of cofrogliptin (HSK7653), a novel ultralong‐acting dipeptidyl peptidase‐4 (DPP‐4) inhibitor, for the treatment of type 2 diabetes (T2D) via a biweekly dosing regimen.MethodsFirstly, a population pharmacokinetics and pharmacodynamics (PopPKPD) model was developed using PK and PD data from a single ascending dose study to simulate the PK and PD time profiles of HSK7653 after multiple dose… Show more
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