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

A Randomized Clinical Trial to Determine the Effect of Dual Glucose-dependent Insulinotropic Polypeptide (GIP)/GLP-1 Receptor Agonist-mediated Weight Loss and Diet on Crohn's Disease Clinical Response: a Pilot Study

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* Patients with the following medical history: small bowel obstruction in the last year, intestinal stricture, known or suspected diagnosis of gastroparesis
* Adults unable to consent
* Pregnant patients (will be confirmed via a pregnancy test)
* Prisoners

About the 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.

What is being tested

• Tirzepatide (drug)
• Mediterranean diet (behavioral)

Sponsor: University of Miami · Participants: 24 · Started: Mar 5, 2025

Contact the study team

• Stephanie Ioannou, MD · Phone: 305-243-2515

Official record on ClinicalTrials.gov — NCT06774079

Locations in the U.S.

Conditions

• Crohn's Disease
• Inflammatory Bowel Disease

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.