Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study

What Was Tested

This registered phase 3 trial tested Tirzepatide.

Participation in this study will last up to 61 weeks, including 52 weeks of treatment.

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

Enrollment: 350 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 had an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC. Have obesity, \[body mass index (BMI) 30 kilograms per meter squared (kg/m2)\]. Have overweight (BMI ≥27 kg/m2 to \<30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions:. Type 2 Diabetes Mellitus (T2DM). Obstructive sleep apnea, or.

The full record lists 11 inclusion and 10 exclusion criteria; among the exclusions: have a current diagnosis of:; crohn's disease; inflammatory bowel disease (ibd) unclassified (formerly known as indeterminate colitis), or.

How the Study Was Run

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

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 2028-04.

It ran at 187 sites in United States (37), Mexico (16), Brazil (15), Poland (12), Spain (10) and France (9).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 7 secondary outcomes, for example Percentage of Participants Who Achieve Clinical Remission, Percentage of Participants Who Achieve Endoscopic Response, Percentage of Participants Who Achieve Clinical Response, Percentage of Participants Who Achieve Endoscopic Remission and Percentage of Participants Achieving Histologic Remission.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 350 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.