Using tirzepatide and diet to treat Crohn's disease
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
This study is testing if a new medication called tirzepatide, along with a Mediterranean diet, can help adults with mild Crohn's disease manage their symptoms better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Drugs / interventions | infliximab, adalimumab |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06774079 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of tirzepatide, a GLP-1 receptor agonist, combined with a Mediterranean diet as an adjunctive therapy for patients with mild Crohn's disease. Participants must be adults with a confirmed diagnosis of Crohn's disease, a BMI of at least 27, and on stable doses of biologic medications. The study will assess the impact of this combined approach on disease management and patient outcomes. The goal is to provide a new treatment option for patients who are currently managing their condition with existing therapies.
Who should consider this trial
Good fit: Ideal candidates are adults with mild Crohn's disease, a BMI of 27 or higher, and currently on stable doses of biologic therapy.
Not a fit: Patients with severe Crohn's disease, those with a BMI under 27, or those with diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve disease management and quality of life for patients with Crohn's disease.
How similar studies have performed: While the use of GLP-1 receptor agonists in inflammatory bowel disease is a novel approach, similar studies have shown promise in other metabolic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Oriana Damas, MD — University of Miami
- Study coordinator: Stephanie Ioannou, MD
- Email: s.ioannou@med.miami.edu
- Phone: 305-243-2515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.