Recruiting

GLP-1 RA & Diet

Sponsor:

University of Miami

Code:

NCT06774079

Conditions

Crohn Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Mediterranean diet

Study Details

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

Study ID

NCT06774079

Start date

Mar 5, 2025

Status verified date

Mar, 2026

Completion date

Mar 5, 2027

Anticipated

Primary completion date

Mar 5, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Tirzepatide group

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

experimental: Mediterranean diet group

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

Interventions

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.

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.

Primary outcome measure

  • Change in percentage of participants retained [ Time Frame: Baseline, 12 weeks ]
  • 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 medications measured by self report [ Time Frame: Up to 12 weeks ]

Central Contacts and Locations

Central contacts

Stephanie Ioannou, MD

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

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Michael Mijares, CRC

305-243-6405mmijares74@med.miami.edu

Principal Investigator:

Oriana Damas, MD

More Information

Sponsor

University of Miami

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

  • inflammatory bowel disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-03-30.