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GLP-1 RA and Diet in Crohn's Disease Patients

This study is looking at how a special diet and an injectable medicine called tirzepatide (Zepbound) might help adults with Crohn's disease. You could be eligible if you have mild Crohn's disease, are already taking stable doses of certain biologic medications (like infliximab or adalimumab), and have a body mass index (BMI) of 27 or higher. The study aims to see how many participants stay in the study and how well they stick to the diet and medication over 12 weeks. The study plans to enroll 24 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 24 participants with Crohn's disease. It is not specified if it is randomized or blinded.
What's involved
You would receive tirzepatide injections weekly, with doses increasing over 12 weeks. If in the diet arm, you would receive weekly 30-minute dietary guidance sessions from a dietician for up to 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes up to 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06774079

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

Recruiting
PHASE4Ages 18+InterventionalSupportive care
University of Miami
~24 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:TirzepatideMediterranean diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in percentage of participants retained
Measured over Baseline, 12 weeks
+2 more outcomes measured

Conditions

Crohn Disease

Explore related trials

Crohn Disease

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Oriana Damas, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Stephanie Ioannou, MD
[email protected]
305-243-2515
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in percentage of participants retainedBaseline, 12 weeks

    The percentage of participants retained will be measured

  • Number of patients who adhere to diet measured by 24 hour dietary recallUp 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 reportUp to 12 weeks

    Number of patients who adhere to medications measured by self report