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NCT Number: NCT06774079

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

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Michael Mijares, CRC

CONTACT

[email protected]

305-243-6405

Oriana Damas, MD

PRINCIPAL_INVESTIGATOR

Stephanie Ioannou, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in percentage of participants retained

    Time frame: Baseline, 12 weeks

    The percentage of participants retained will be measured

  2. Number of patients who adhere to diet measured by 24 hour dietary recall

    Time frame: Up to 12 weeks

    Number of patients who adhere to diet measured by 24 hour dietary recall

  3. Number of patients who adhere to medications measured by self report

    Time frame: Up to 12 weeks

    Number of patients who adhere to medications measured by self report

Secondary outcomes

  1. Number of calls completed

    Time frame: Up to 12 weeks

    Number of calls completed. Calls will be made either on a phone or virtually using Zoom.

  2. Number of dietary recall (ASA24) surveys completed

    Time frame: Up to 12 weeks

    Number of dietary recall (ASA24) surveys completed

  3. Number of clinical symptom (HBI/CDAI) surveys completed

    Time frame: Up to 12 weeks

    Number of clinical symptom (HBI/CDAI) surveys completed

  4. Number of blood samples completed

    Time frame: Up to 12 weeks

    Number of blood samples completed

  5. Number of stool samples completed

    Time frame: Up to 12 weeks

    Number of stool samples completed

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Ioannou, MD

CONTACT

[email protected]

305-243-2515

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 14, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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