Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06995651
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cystic Fibrosis-related Diabetes
  • Pancreatic Insufficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dorzagliatin — DRUG
    Randomized, double-blind, cross-over study of Dorzagliatin 50 mg orally twice daily for 7 days compared to matched-placebo orally twice daily for 7 days.
  • Placebo — DRUG
    Randomized, double-blind, cross-over study of Dorzagliatin 50 mg orally twice daily for 7 days compared to matched-placebo orally twice daily for 7 days.

Study Details

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.

Key Dates

Start date
Oct 21, 2025
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Dorzagliatin
    Dorzagliatin 50 mg orally twice daily for 7 days
  • Placebo Comparator: Placebo
    matched-placebo orally twice daily for 7 days

Primary Outcome Measure

Drug concentrations (PK; Cmax) [ Time Frame: 2 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Hospital of University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Pennsylvania Center for Human Phenomic Science (CHPS)PhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By research site
Hospital of University of Pennsylvania· Philadelphia, PAUniversity of Pennsylvania Center for Human Phenomic Science (CHPS)· Philadelphia, PA

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