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

NCT06774079 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 20240982
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Keywords

inflammatory bowel disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Number of calls completed

  Up to 12 weeks

• Number of dietary recall (ASA24) surveys completed

  Up to 12 weeks

• Number of clinical symptom (HBI/CDAI) surveys completed

  Up to 12 weeks

• Number of blood samples completed

  Up to 12 weeks

• Number of stool samples completed

  Up to 12 weeks

Study Arms (2)

Tirzepatide group

EXPERIMENTAL

Participants will be in this group for up to 12 weeks.

Drug: Tirzepatide; Behavioral: Mediterranean diet

Mediterranean diet group

EXPERIMENTAL

Participants will be in this group for up to 12 weeks.

Behavioral: Mediterranean diet

Interventions

Tirzepatide DRUG

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.

Tirzepatide group

Mediterranean diet BEHAVIORAL

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.

Mediterranean diet group; Tirzepatide group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

Tirzepatide; Diet, Mediterranean

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Oriana Damas, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Ioannou, MD

CONTACT

305-243-2515; s.ioannou@med.miami.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 14, 2025
• Study Start: March 5, 2025
• Primary Completion (Estimated): March 5, 2027
• Study Completion (Estimated): March 5, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)