Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis

This study is designed to determine the pharmacokinetic and pharmacodynamic response of dorzagliatin 50 mg twice daily following 7-day administration in individuals with pancreatic insufficient cystic fibrosis and abnormal glucose tolerance when compared to randomized, double-blind 7-day administration of placebo in a cross-over fashion. We hypothesize that dorzagliatin administration will result in significant drug concentrations and improved glucose tolerance, early-phase insulin secretion, glucagon suppression, and hepatic glycogen storage assessed during a standardized mixed-meal tolerance test.

NCT Number	NCT06995651
Lead Sponsor	University of Pennsylvania
Conditions	Pancreatic Insufficiency, Cystic Fibrosis-related Diabetes
Enrollment	15 participants
Start Date	2025-10-21
Primary Completion	2027-07 (estimated)
Study Completion	2027-07 (estimated)
Updated on ClinicalTrials.gov	2026-04-09