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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 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.

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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.

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

FieldValue
Enrollment Target 15 participants
Start Date 2025-10-21
Est. Completion 2027-07
Phase Phase 1

Sponsor

University of Pennsylvania

1,423 total trials

What the Registry Record Tells You About NCT06995651

The ClinicalTrials.gov registry entry for NCT06995651 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 106-participant average among 10 other Cystic Fibrosis-related Diabetes trials with a reported enrollment target (86% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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.

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