NCT06774079Active, not recruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 8 Jan 2025
- Start date
- 5 Mar 2025
- Primary completion date
- 5 Mar 2027
- Lead sponsor
- University of Miami
- Diseases
- Crohn's disease
- NCT number
- NCT06774079
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 24
- From 5 Mar 2025 to the primary completion date, 5 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients already on GIP/GLP-1 RA therapy
Other illness
- 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
Age
- Patients under 18 years of age
Other
- Patients with ulcerative colitis
- Patients with infectious colitis
- BMI\<27 kg/m2
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.