Tests dorzagliatin for blood sugar problems in people with cystic fibrosis
Tests dorzagliatin against placebo in adults with cystic fibrosis and abnormal glucose tolerance.
Plain-language title generated from the registry record
Registry title: Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis
Key facts
- Where
- Philadelphia, United StatesSee the 2 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with cystic fibrosis who need pancreatic enzyme replacement and have abnormal glucose tolerance. It tests dorzagliatin against placebo for 7 days each.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Confirmed cystic fibrosis (positive sweat test or CFTR mutation test) with pancreatic insufficiency and abnormal glucose tolerance or cystic fibrosis-related diabetes. With fasting high blood sugar, HbA1c must be 8% (64 mmol/mol) or lower and C-peptide at least 1.2 ng/mL.
- Earlier treatment
- Cannot have changed CFTR modulator therapy in the last 3 months. Cannot have used CYP3A4 inhibitors or inducers, or herbal remedies such as St. John's Wort within 14 days before dosing.
- Biomarker or test result
- Positive sweat test or CFTR mutation; abnormal glucose tolerance on an oral glucose tolerance test, or diagnosed cystic fibrosis-related diabetes.
Main reasons for not taking part
- Diabetes not caused by cystic fibrosis, such as type 1 diabetes
- Pregnancy or breastfeeding
- Lung flare-up needing IV antibiotics or systemic glucocorticoids in the last 4 weeks
- Pancreatitis with symptoms in the last year
- Earlier lung, liver or other solid organ transplant
Read by machine on 9 November 2026.
Where in United States
- Hospital of University of PennsylvaniaPhiladelphia, United StatesTaking people
- University of Pennsylvania Center for Human Phenomic Science (CHPS)Philadelphia, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Michael R. Rickels, MD, MS
- Trial code
- NCT06995651
- Record updated
- 31 August 2026
- Original description
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.Read full original descriptionShow less
Pharmacokinetic and Pharmacodynamic Effects of Dorzagliatin in Pancreatic Insufficient-Cystic Fibrosis: A Randomized Double-blind, Cross-over Trial
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.
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); 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: 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; Prior lung, liver or another solid organ transplant; Established diagnosis of non-CF diabetes (e.g. type 1 diabetes); History of clinically symptomatic pancreatitis within the last year; 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; 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; Pregnancy or lactation; a negative urine pregnancy test will be required at enrollment.