Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease

What Was Tested

In this phase 2 trial, researchers set out to test Tirzepatide.

Current therapies are used to control the inflammation due to Crohn's disease in your digestive tract.

It had two arms (groups): Tirzepatide group (experimental) and Standard of Care Arm (active comparator).

The registry classes the interventions as drug.

Who Took Part

60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Subjects 18 to 80 years of age, inclusive, at the time of consent. Confirmed diagnosis of Crohn's disease based on documented findings on endoscopy and histopathology. Active ileal or ileocolonic inflammation on colonoscopy defined as. Anti-TNF: Infliximab, Adalimumab, Certolizumab, Golimumab. Anti-integrin agent: vedolizumab.

The full record lists 11 inclusion and 18 exclusion criteria; among the exclusions: age \< 18 or \> 80 years; pregnant or breastfeeding female; BMI \< 25.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Being open-label, the Tirzepatide study did not mask who received what.

It started in 2025-05-13 with completion listed for 2028-05.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Proportion and number of participants who have treatment emergent adverse events, serious adverse events, discontinuation of study intervention due to adverse events and injection-site reactions by CTCAE v4.0 (time frame: From enrollment to the end of treatment at month 7). Proportion and number of participants with endoscopic remission as defined by SES-CD < 4 with no ulcer subscore >1 (time frame: From enrollment to the end of treatment at month 7).

It also tracked 6 secondary outcomes, for example Proportion and number of participants who achieve clinical remission defined by a Harvey Bradshaw Index < 5.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 60 people.

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.