Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06995651

Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis

Led by University of Pennsylvania · Updated on 2026-04-09

15

Participants Needed

2

Research Sites

88 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form.
  • Willingness to comply with all study procedures and availability for the study duration.
  • Male or female aged 18 years or older at consent.
  • Confirmed cystic fibrosis diagnosis by positive sweat test or CFTR mutation analysis.
  • Pancreatic insufficiency requiring pancreatic enzyme replacement.
  • Abnormal glucose tolerance or cystic fibrosis-related diabetes diagnosed by OGTT or clinical criteria.
  • No restriction on enrollment of individuals with CFRD without fasting hyperglycemia.
  • For females able to conceive: use of highly effective contraception during study participation.
Not Eligible

You will not qualify if you...

  • Diagnosis of non-cystic fibrosis diabetes (e.g., type 1 diabetes).
  • Pregnancy or lactation; negative pregnancy test required at enrollment.
  • Pulmonary exacerbation needing IV antibiotics or systemic steroids within 4 weeks before randomization.
  • Use of CYP3A4 inhibitors or inducers.
  • Use of herbal remedies including St. John's Wort within 14 days prior to dosing.
  • Change in CFTR modulator therapy within previous 3 months.
  • History of symptomatic pancreatitis within last year.
  • Prior lung, liver, or other solid organ transplant.
  • Abnormal kidney function (creatinine >2x ULN or potassium >5.5 mEq/L).
  • Persistent liver function test elevation >2x ULN.
  • Uncontrolled high triglycerides (>500 mg/dL) or cholesterol (>250 mg/dL).
  • Hyperuricemia (serum uric acid >1.5 times ULN).
  • Anemia (hemoglobin <10 g/dL).
  • Any illness or condition that could affect study results or increase risk as judged by investigator.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Hospital of University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

2

University of Pennsylvania Center for Human Phenomic Science (CHPS)

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

P

Paola Alvarado, MSCR

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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