RecruitingPhase 1NCT06995651

Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis

Pharmacokinetic and Pharmacodynamic Effects of Dorzagliatin in Pancreatic Insufficient-Cystic Fibrosis: A Randomized Double-blind, Cross-over Trial


Sponsor

University of Pennsylvania

Enrollment

15 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dorzagliatin and a drug called Placebo for people with cystic fibrosis-related diabetes and pancreatic insufficiency. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDorzagliatin

Randomized, double-blind, cross-over study of Dorzagliatin 50 mg orally twice daily for 7 days compared to matched-placebo orally twice daily for 7 days.

DRUGPlacebo

Randomized, double-blind, cross-over study of Dorzagliatin 50 mg orally twice daily for 7 days compared to matched-placebo orally twice daily for 7 days.


Locations(2)

Hospital of University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pennsylvania Center for Human Phenomic Science (CHPS)

Philadelphia, Pennsylvania, United States

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NCT06995651


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