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Recruiting NCT06774079

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

Phase IV Interventional Crohn Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tirzepatide, Mediterranean diet.
Who it may be relevant to
Registry conditions: Crohn Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug 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.
  • Behavioral 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 measures

  • 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]
Secondary outcome measures (5)
  • Number of calls completed [Time frame: Up to 12 weeks]
  • Number of dietary recall (ASA24) surveys completed [Time frame: Up to 12 weeks]
  • Number of clinical symptom (HBI/CDAI) surveys completed [Time frame: Up to 12 weeks]
  • Number of blood samples completed [Time frame: Up to 12 weeks]
  • Number of stool samples completed [Time frame: Up to 12 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT06774079 · 20240982

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗