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Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients

StatusRecruiting
PhasePhase 4
Started2025-03-05
View on ClinicalTrials.gov ↗

Amendment history

2026-03-24
Study Status v3
Primary completion date2026-03-05→2027-03-05
Completion date2026-03-05→2027-03-05
2025-04-28
Study Status, Outcome Measures, Contacts/Locations v2
Secondary endpoints5 entries, revised
Number of clinical symptom (HBI/CDAI) surveys completed
Study sitescontacts updated at 1 of 1 site
2025-03-14
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-03-01→2026-03-05
Completion date2026-03-01→2026-03-05
Start dateestimated 2025-03-01→confirmed 2025-03-05
Study sitesdetails revised at 1 of 1 site
2025-01-08
Original filing
The purpose of this study is to use diet and an injectable medication called tirzepatide (Zepbound) glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist (GIP-GLP-1 RA) medication as adjunctive therapy (another treatment used together with the primary treatment) for Crohn's disease patients with mild disease who are on stable doses of biologic medication (infliximab or adalimumab) and who have a body mass index (BMI) of at least 27.
Trial Details
NCT Number NCT06774079
Lead Sponsor University of Miami
Conditions Crohn Disease
Enrollment 24 participants
Start Date 2025-03-05
Primary Completion 2027-03-05 (estimated)
Study Completion 2027-03-05 (estimated)
Updated on ClinicalTrials.gov 2026-03-30