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GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance

StatusRecruiting
PhasePhase 2
Started2021-07-16
View on ClinicalTrials.gov ↗
Diabetes is a major co-morbidity in pancreatic insufficient cystic fibrosis (PI-CF) and associated with worse outcomes. While reduced β-cell mass contributes to the insulin secretory defects that characterizes cystic fibrosis-related diabetes (CFRD), other modifiable determinants appear operative in the emergence and progression of abnormal glucose tolerance towards diabetes. Identifying interventions to preserve β-cell function are crucial for delaying and potentially preventing CFRD development. In this study, we hypothesize that weekly administration of the long-acting glucagon-like peptide-1 (GLP-1) agonist dulaglutide will improve defective early-phase insulin secretion and improve glucose tolerance during a mixed-meal tolerance test.

Amendment record

Amended 9 times since 2021-01-26; most recent filed 2026-05-13. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-05-13
Amendment Study Status v9
2025-04-23
Amendment Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v8
2025-03-12
Amendment Study Identification, Study Status, Contacts/Locations v7
2024-02-27
Amendment Study Status, Eligibility v6
2023-02-18
Amendment Study Status v5
2023-01-11
Amendment Study Status, Study Description, IPDSharing v4
2022-01-07
Amendment Study Status, Contacts/Locations v3
2021-05-17
Amendment Study Status v2
2021-04-21
Amendment Not Yet RecruitingRecruiting Study Identification, Study Status, Contacts/Locations v1
2021-01-26
Original filing
Trial Details
NCT Number NCT04731272
Lead Sponsor University of Pennsylvania
Collaborators: Children's Hospital of Philadelphia, Children's Hospital Colorado
Conditions Cystic Fibrosis, Pancreatic Insufficiency, Abnormal Glucose Tolerance, Diabetes
Enrollment 30 participants
Start Date 2021-07-16
Primary Completion 2027-06-30 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-18