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

Phase 4

Recruiting

• Conditions: Crohn Disease
• Interventions: Drug: Tirzepatide; Behavioral: Mediterranean diet

• Registration Number: NCT06774079
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Study First Posted: 2025-01-14
• Study Start: 2025-03-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-03-05
• Study Completion: 2026-03-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tirzepatide group	Tirzepatide	Participants will be in this group for up to 12 weeks.
Tirzepatide group	Mediterranean diet	Participants will be in this group for up to 12 weeks.
Mediterranean diet group	Mediterranean diet	Participants will be in this group for up to 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change in percentage of participants retained	Baseline, 12 weeks	The percentage of participants retained will be measured
Number of patients who adhere to diet measured by 24 hour dietary recall	Up to 12 weeks	Number of patients who adhere to diet measured by 24 hour dietary recall
Number of patients who adhere to medications measured by self report	Up to 12 weeks	Number of patients who adhere to medications measured by self report

Secondary Outcome Measures

Name	Time	Method
Number of calls completed	Up to 12 weeks	Number of calls completed. Calls will be made either on a phone or virtually using Zoom.
Number of dietary recall (ASA24) surveys completed	Up to 12 weeks	Number of dietary recall (ASA24) surveys completed
Number of clinical symptom (HBI/CDAI) surveys completed	Up to 12 weeks	Number of clinical symptom (HBI/CDAI) surveys completed
Number of blood samples completed	Up to 12 weeks	Number of blood samples completed
Number of stool samples completed	Up to 12 weeks	Number of stool samples completed

Trial Locations

Locations (2)

University of Miami; 🇺🇸 Miami, Florida, United States

University of Miami; 🇺🇸 Miami, Florida, United States