Dorzagliatin for Cystic Fibrosis

Recruiting at 1 trial location

Overseen By Paola Alvarado, MSCR

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Pennsylvania

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers, Herbal remedies

Disqualifiers: Non-CF diabetes, Pregnancy, Pulmonary exacerbation, others

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is designed to determine the pharmacokinetic and pharmacodynamic response of dorzagliatin 75 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.

Research Team

Michael R Rickels, MD, MS

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for individuals with pancreatic insufficient cystic fibrosis and abnormal glucose tolerance. Participants should be able to undergo a mixed-meal tolerance test.

Inclusion Criteria

Provision of signed and dated informed consent form

I am willing and able to follow all study requirements.

Abnormal glucose tolerance defined by OGTT criteria for EGI, IGT, or CFRD, or diagnosed CFRD

Exclusion Criteria

I have been diagnosed with diabetes that is not cystic fibrosis-related.

Pregnancy or lactation; a negative urine pregnancy test will be required at enrollment

Hyperuricemia: serum uric acid >1.5 times ULN

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dorzagliatin 75 mg or placebo twice daily for 7 days in a cross-over design

7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pharmacokinetic and pharmacodynamic assessments

2 months

Treatment Details

Interventions

• Dorzagliatin

Trial Overview The study tests dorzagliatin (75 mg twice daily) against a placebo over 7 days, measuring its effects on drug levels in the body, glucose control, insulin secretion, glucagon levels, and liver glycogen storage.

Participant Groups

Group I: Dorzagliatin Experimental Treatment 2 Interventions

Dorzagliatin 75 mg orally twice daily for 7 days

Group II: Placebo Placebo Group 2 Interventions

matched-placebo orally twice daily for 7 days

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+