Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

What Was Tested

The trial (phase 3) is built around Tirzepatide.

The maximum duration of this study is up to 61 weeks.

It had two arms (groups): Mirikizumab + Tirzepatide (experimental) and Mirikizumab + Placebo (experimental).

Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC). Tirzepatide administered SC.

Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.

The registry classes the interventions as drug.

Who Took Part

The registry lists 290 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD. Type 2 diabetes mellitus (T2DM). Obstructive sleep apnea, or. Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline.

The full record lists 11 inclusion and 9 exclusion criteria; among the exclusions: have a current diagnosis of ulcerative colitis (uc), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis; have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum; currently have or are suspected to have an abscess.

How the Study Was Run

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

The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

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

Neither the participants nor the staff measuring them knew who was on Tirzepatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2025-06-26 with completion listed for 2028-05.

It ran at 183 sites in United States (35), Mexico (16), Brazil (15), Poland (12), France (10) and Spain (10).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 6 secondary outcomes, for example Percentage of Participants Who Simultaneously Achieve Clinical Remission by CDAI and Endoscopic Remission, Percentage of Participants Who Achieved Maintenance of Clinical Remission by CDAI, Percentage of Participants Who Achieved Maintenance of Endoscopic Remission and Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 290 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.