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Pharmacokinetic and Pharmacodynamic Effects of Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis: A Randomized Double-Blind, Cross-Over Trial
Led by University of Pennsylvania · Updated on 2026-04-09
15
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of dorzagliatin 50 mg taken twice daily for 7 days in people with pancreatic insufficient cystic fibrosis who have abnormal glucose tolerance. The study compares dorzagliatin with a placebo in a randomized, double-blind, cross-over design to understand how the drug is processed in the body and its impact on glucose control, insulin secretion, glucagon suppression, and liver glycogen storage. Participants will receive dorzagliatin or a matching placebo orally twice a day for 7 days each, in a cross-over fashion. This means each participant will receive both treatments in different periods, allowing direct comparison of the drug's effects against placebo. The study is designed to measure drug levels and glucose tolerance after each treatment period. During the study, participants will undergo standardized mixed-meal tolerance tests to assess early-phase insulin secretion, glucagon suppression, and liver glycogen storage. Researchers will monitor drug concentrations and glucose response over about 2 months. Participants will be assessed through clinical evaluations and laboratory tests to gather these measurements. The trial is managed through the University of Pennsylvania and aims to better understand dorzagliatin's pharmacokinetics and pharmacodynamics in this specific population.
CONDITIONS
Brief Title
Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and be available 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 defined by OGTT criteria or diagnosed cystic fibrosis-related diabetes
- Participants with cystic fibrosis-related diabetes without fasting hyperglycemia are eligible
- Participants with cystic fibrosis-related diabetes with fasting hyperglycemia must have HbA1c of 8% or less and a random C-peptide of 1.2 ng/mL or more
- Females of reproductive potential must use highly effective contraception during the study, excluding condoms alone
You will not qualify if you...
- Diagnosis of non-cystic fibrosis diabetes (e.g., type 1 diabetes)
- Pregnancy or breastfeeding; negative urine pregnancy test required at enrollment
- Pulmonary exacerbation requiring 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 before dosing
- Change in cystic fibrosis transmembrane conductance regulator modulator therapy in previous 3 months
- History of symptomatic pancreatitis within last year
- Prior lung, liver, or other solid organ transplant
- Abnormal kidney function (creatinine >2x upper limit) or potassium >5.5 mEq/L
- Abnormal liver function with persistent elevated liver tests >2 times upper limit
- Uncontrolled hyperlipidemia (triglycerides >500 or cholesterol >250 mg/dL)
- Hyperuricemia (serum uric acid >1.5 times upper limit)
- Anemia with hemoglobin less than 10 g/dL
- Any illness or condition that may affect study results or increase risk to the participant
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Two treatment periods of 7 days each
Participants receive Dorzagliatin 50 mg orally twice daily for 7 days and matched placebo orally twice daily for 7 days in a randomized, double-blind, cross-over design.
Multiple visits during each 7-day treatment period for dosing and assessments
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
Research Team
P
Paola Alvarado, MSCR
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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