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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: Tirzepatide; Behavioral: Mediterranean diet

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Stephanie Ioannou, MD; Phone Number: 305-243-2515; Email: s.ioannou@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Principal Investigator: Oriana Damas, MD
      • Contact: Michael Mijares, CRC; Phone Number: 305-243-6405; Email: mmijares74@med.miami.edu
      • Sub-Investigator: Stephanie Ioannou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tirzepatide group; Participants will be in this group for up to 12 weeks.	Drug: Tirzepatide; Patients in this arm will receive tirzepatide starting at 2.5 mg subcutaneous (SC) weekly for 4 weeks, then increase to 5 mg SC weekly for 4 weeks and then 7.5 mg SC weekly for the last 4 weeks of the intervention period. Place of injection includes abdomen, thigh, or upper arm.; Behavioral: Mediterranean diet; The diet is comprised of a content of 25-30 grams of fiber per day (from fruits, vegetables, whole grains) that is low in animal protein and minimally processing of foods The diet arm will receive dietary guidance from our dietician on weekly 30-minute guided sessions. Participants will be encouraged to adhere to the diet for up to three meals per day for the duration of the study.
Experimental: Mediterranean diet group; Participants will be in this group for up to 12 weeks.	Behavioral: Mediterranean diet; The diet is comprised of a content of 25-30 grams of fiber per day (from fruits, vegetables, whole grains) that is low in animal protein and minimally processing of foods The diet arm will receive dietary guidance from our dietician on weekly 30-minute guided sessions. Participants will be encouraged to adhere to the diet for up to three meals per day for the duration of the study.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Oriana Damas, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2025
• Primary Completion (Estimated): March 5, 2027
• Study Completion (Estimated): March 5, 2027

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): January 14, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: inflammatory bowel disease
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Crohn Disease; Inflammatory Bowel Diseases; Amino Acids, Peptides, and Proteins; Proteins; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Diet; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Diet, Mediterranean; Tirzepatide
• Other Study ID Numbers: 20240982

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No