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NCT06995651 · ClinicalTrials.gov registry record · Phase 1
Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis
A Phase 1 study of Cystic Fibrosis-related Diabetes and Pancreatic Insufficiency, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 2
- Study locations
NCT06995651: Recruiting Phase 1 study of Cystic Fibrosis-related Diabetes and Pancreatic Insufficiency, sponsored by University of Pennsylvania.
NCT06995651 is a Phase 1 study of Cystic Fibrosis-related Diabetes and Pancreatic Insufficiency that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 15 participants, below the 106-participant average among 10 other Cystic Fibrosis-related Diabetes trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06995651, a Phase 1 study of Cystic Fibrosis-related Diabetes and Pancreatic Insufficiency, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 2
- Study locations
Study 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 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.
Primary Outcome
Assessed by the peak glucose during a standardized mixed-meal tolerance test following 7-day administration of study drug
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dorzagliatin
Study Locations (2)
Pennsylvania
- Hospital of University of Pennsylvania - Philadelphia
- University of Pennsylvania Center for Human Phenomic Science (CHPS) - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-10-21 |
| Est. Completion | 2027-07 |
| Phase | Phase 1 |
What NCT06995651 shows while recruiting
NCT06995651 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 106-participant average among 10 other Cystic Fibrosis-related Diabetes trials with a reported enrollment target (86% lower).
The record links to 2 conditions, with Cystic Fibrosis-related Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06995651 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06995651 about?
NCT06995651 is a clinical study titled "Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis". 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 fibrosis and abnormal glucose tolerance when compared to randomized, double-blind 7-day administrat...
What is the current status of trial NCT06995651?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2025-10-21. Estimated completion is 2027-07.
What conditions does trial NCT06995651 study?
This clinical trial studies the following conditions: Cystic Fibrosis-related Diabetes, Pancreatic Insufficiency.
What interventions are being tested in trial NCT06995651?
The interventions under investigation include: Placebo (DRUG), Dorzagliatin (DRUG).
Who is sponsoring clinical trial NCT06995651?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06995651 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis-related Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06995651's enrollment target sits among peer trials
15 8th of 10 higher than 2 of 10 other Cystic Fibrosis-related Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis-related Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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