Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)

What Was Tested

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

It had two arms (groups): Tirzepatide (experimental) and Optimized Standard of Care anti-diarrheal therapy (active comparator).

The registry classes the interventions as drug.

Who Took Part

20 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: Informed consent will be obtained before any study-related procedures. Age \> 18 and \<80 years.

The full record lists 5 inclusion and 24 exclusion criteria; among the exclusions: participants with a proven history of ulcerative colitis and history of 1,2, modified -2 or 3 stage ipaa and ileostomy takedown; ability to access internet for electronic database entry; prior exposure to tirzepatide or other glp-1ra.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

The Tirzepatide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Tirzepatide study: the participants and staff both knew the treatment.

It started in 2026-09 with completion listed for 2027-09.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example The proportion of patients achieving an average bowel frequency of ≤8 bowel movements daily, Change in Cleveland Clinic Global Quality of Life (QoL) scale, Change in Patient-Reported Outcomes Measurement Information System (PROMIS) incontinence measure, Number of Participants with AEs, SAEs and AEs Leading to Discontinuation of Study Intervention, Number of Participants with worsening laboratory values and Number of Participants with changes in nausea.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Tirzepatide in 20 people.

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

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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