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

What Was Tested

In this phase 4 trial, researchers set out to test Tirzepatide.

It had two arms (groups): Tirzepatide group (experimental) and Mediterranean diet group (experimental).

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

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

The registry classes the interventions as behavioral and drug.

Who Took Part

24 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult patients (≥18 years old). Confirmed diagnosis of Crohn's disease. BMI ≥ 27 kg/m2.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: patients under 18 years of age; patients with ulcerative colitis; patients with infectious colitis.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

In this single-blind Tirzepatide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2025-03-05 with completion listed for 2027-03-05.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): 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).

It also tracked 5 secondary outcomes, for example Number of calls completed, Number of dietary recall (ASA24) surveys completed, Number of clinical symptom (HBI/CDAI) surveys completed, Number of blood samples completed and Number of stool samples completed.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Tirzepatide in 24 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.