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RECRUITING Phase 1

Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis

NCT06995651 · View on ClinicalTrials.gov ↗

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

1,457 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06995651

The ClinicalTrials.gov registry entry for NCT06995651 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,457 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06995651 reports 2 study locations spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06995651?

The interventions under investigation include: Placebo (DRUG), Dorzagliatin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06995651?

This trial is sponsored by University of Pennsylvania, which has 1,457 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial