Status:
RECRUITING
Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis
Lead Sponsor:
University of Pennsylvania
Conditions:
Pancreatic Insufficiency
Cystic Fibrosis-related Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged ≥18 years on date of consent.
- Confirmed diagnosis of CF, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria.
- Pancreatic insufficiency defined by clinical requirement for pancreatic enzyme replacement.
- Abnormal glucose tolerance defined by OGTT criteria for EGI, IGT, or CFRD, or diagnosed CFRD.
- There will be no restriction on enrollment of individuals with CFRD but without fasting hyperglycemia (fasting hyperglycemia is defined as fasting glucose ≥126 mg/dL)
- a. Individuals with CFRD and fasting hyperglycemia (defined as above or by the use of basal insulin therapy) must also have a HbA1c ≤8% and a random (non-fasting) C- peptide ≥1.2 ng/mL \[15\].
- For females of reproductive potential: use of highly effective contraception method for the during of study participation; oral contraceptives, intra-uterine devices, Norplant®, Depo- Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.
Exclusion
- Established diagnosis of non-CF diabetes (e.g. type 1 diabetes).
- Pregnancy or lactation; a negative urine pregnancy test will be required at enrollment.
- Pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to randomization.
- Treatment with either CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, indinavir, ritonavir, saquinavir, telithromycin, boceprevir, nelfinavir, telaprevir, conivaptan, nefazodone, etc.) or inducers (e.g. phenobarbital, other barbiturates, carbamazepine, phenytoin, rifampicin, dexamethasone, etc.).
- Use of herbal remedies, including St. John's Wort within 14 days prior to dosing.
- Change in CFTR modulator therapy in the previous 3 months.
- History of clinically symptomatic pancreatitis within the last year.
- Prior lung, liver or another solid organ transplant.
- Abnormal kidney function: creatinine \>2x upper limit of normal (ULN) or potassium \>5.5mEq/L on non-hemolyzed specimen.
- Abnormal liver function: persistent elevation of liver function tests \>2.0 times ULN.
- Uncontrolled hyperlipidemia: triglycerides \>500 or cholesterol \>250 mg/dl.
- Hyperuricemia: serum uric acid \>1.5 times ULN.
- Anemia: hemoglobin \<10 g/dL.
- History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk to the subject.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06995651
Start Date
December 1 2025
End Date
July 1 2027
Last Update
November 12 2025
Active Locations (2)
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1
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
2
University of Pennsylvania Center for Human Phenomic Science (CHPS)
Philadelphia, Pennsylvania, United States, 19104