RecruitingCrohn Disease
Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Miami
You may qualify if…
- ✓ Adult patients (≥18 years old)
- ✓ Confirmed diagnosis of Crohn's disease
- ✓ Mildly active disease, defined by clinical symptoms using the Harvey Bradshaw Index (HBI) score between 5 and 7 (the HBI is a continuous score ranging from 0-16 where \<4 is considered remission)
- ✓ BMI ≥ 27 kg/m2
- ✓ Patients will be on stable doses of medical therapy (anti-tumor necrosis factor (TNF) alpha blockers)
You may not qualify if…
- ✕ Patients under 18 years of age
- ✕ Patients with ulcerative colitis
- ✕ Patients with infectious colitis
- ✕ BMI\<27 kg/m2
- ✕ Patients with type 1 or type 2 diabetes
- ✕ Contraindications to a GIP/GLP-1 RA, including patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2
- ✕ Patients already on GIP/GLP-1 RA therapy
- ✕ Patients with the following chronic symptoms: severe constipation, nausea, and/or vomiting
Where it's recruiting
Florida
Miami
Source: ClinicalTrials.gov · NCT06774079 · last updated 2026-03-30