A model‐informed approach to accelerate the clinical development of cofrogliptin ( HSK7653 ), a novel ultralong‐acting dipeptidyl peptidase‐4 inhibitor
Authors' conclusion
Successful waiver approval for the phase 2b dose-finding study was achieved through model-informed recommendations, facilitating the clinical development of HSK7653 and other DPP-4 inhibitors.
Study context
- Population
- Healthy subjects (single ascending dose study); published studies of Eastern Asian subjects for all DPP-4 inhibitors; T2D patients in late clinical trials
- Outcome
- Predicted vs observed PK/DPP-4 inhibition/HbA1c profiles of HSK7653
Methodological detailsmodel-informed drug development, population PK/PD model, model-based meta-analysis, validation in late clinical trials, Waiver approval for the phase 2b dose-finding study achieved through model-informed recommendations
- Model-informed drug development
- Population PK/PD model
- Model-based meta-analysis
- Validation in late clinical trials
- Waiver approval for the phase 2b dose-finding study achieved through model-informed recommendations
Pooled result
As reported in the abstract
- PK/DPP-4 inhibition/HbA1c profiles of T2D patients treated with HSK7653 matched the modelled data
- PopPKPD and model-based meta-analysis (MBMA) models predicted multiple ascending dosing PK and PD from single ascending dosing data, and long-term efficacy in T2D patients, based on healthy subjects
Original publication
A model‐informed approach to accelerate the clinical development of cofrogliptin ( HSK7653 ), a novel ultralong‐acting dipeptidyl peptidase‐4 inhibitor. Diabetes Obes Metab. Published 12 November 2023. doi:10.
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