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RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests diet and tirzepatide (Zepbound) shots as added treatments for Crohn’s disease. It is for adults with mild Crohn’s disease, a body mass index (BMI) of at least 27, and stable doses of infliximab or adalimumab.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have a confirmed diagnosis of Crohn’s disease.
  • Have mildly active disease, with a symptom score called the Harvey Bradshaw Index (HBI) between 5 and 7.
  • Have a BMI of 27 or higher. BMI is a measure based on height and weight.
  • Take stable doses of anti-TNF medicines, such as infliximab or adalimumab, which reduce inflammation.

Who can't join

  • Under age 18 or have a BMI below 27.
  • Have ulcerative colitis or colitis caused by an infection. Colitis means swelling and irritation in the colon.
  • Have type 1 or type 2 diabetes.
  • Cannot safely take GIP/GLP-1 medicines, including because of a personal or family history of medullary thyroid cancer, or multiple endocrine neoplasia type 2 (a condition affecting hormone-making glands).
  • Already take a GIP/GLP-1 medicine.
  • Have long-term severe constipation, nausea, or vomiting.
  • Had a blockage in the small intestine in the past year, have a narrowed intestine, or have known or suspected gastroparesis (slow stomach emptying).
  • Cannot consent to join, are pregnant (checked with a pregnancy test), or are a prisoner.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

FL