NCT06995651 Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis
| NCT ID | NCT06995651 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Pennsylvania |
| Condition | Pancreatic Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-10-21 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2025-10-21 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Male or female, aged ≥18 years on date of consent. 4. Confirmed diagnosis of CF, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria. 5. Pancreatic insufficiency defined by clinical requirement for pancreatic enzyme replacement. 6. Abnormal glucose tolerance defined by OGTT criteria for EGI, IGT, or CFRD, or diagnosed CFRD. 7. 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 \[15\]. 8. 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 Criteria: 1. Established diagnosis of non-CF diabetes (e.g. type 1 diabetes). 2. Pregnancy or lactation; a negative urine pregnancy test will be required at enrollment. 3. Pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to randomization. 4. 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.). 5. Use of herbal remedies, including St. John's Wort within 14 days prior to dosing. 6. Change in CFTR modulator therapy in the previous 3 months. 7. History of clinically symptomatic pancreatitis within the last year. 8. Prior lung, liver or another solid organ transplant. 9. Abnormal kidney function: creatinine \>2x upper limit of normal (ULN) or potassium \>5.5mEq/L on non-hemolyzed specimen. 10. Abnormal liver function: persistent elevation of liver function tests \>2.0 times ULN. 11. Uncontrolled hyperlipidemia: triglycerides \>500 or cholesterol \>250 mg/dl. 12. Hyperuricemia: serum uric acid \>1.5 times ULN. 13. Anemia: hemoglobin \<10 g/dL. 14. 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.
Contact & Investigator
Michael R Rickels, MD, MS
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT06995651 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06995651 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06995651 currently recruiting?
Yes, NCT06995651 is actively recruiting participants. Contact the research team at Paola.Alvarado@Pennmedicine.upenn.edu for enrollment information.
Where is the NCT06995651 trial being conducted?
This trial is being conducted at Philadelphia, United States, Philadelphia, United States.
Who is sponsoring the NCT06995651 clinical trial?
NCT06995651 is sponsored by University of Pennsylvania. The principal investigator is Michael R Rickels, MD, MS at University of Pennsylvania. The trial plans to enroll 15 participants.