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

NCT07756359 · Not yet recruiting

Last updated 2026-08-27

This clinical trial is testing whether the medication tirzepatide can help reduce chronic high bowel frequency in adults who have undergone ileal pouch-anal anastomosis (IPAA) surgery.

Status Not yet recruiting Approved but enrollment has not started.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 20 people Planned (estimated).

Who can join Ages 18–80 · all sexes

Timeline Started 2026-09 · est. completion 2027-09

Where 5 sites · United States

What this study is testing ClinicalTrials.gov NCT07756359 ↗

Description as written by the study sponsor.

The goal of this clinical trial is to learn if Tirzepatide (Zepbound) can decrease bowel frequency in patients that have an ileal-pouch anal anastomosis (IPAA or pouch) better than standard of care anti-diarrheal therapy. The main question it aims to answer is: Does Tirzepatide reduce bowel frequency better than standard of care anti-diarrheal therapy in patients that have a pouch Participants will: Visit the clinic 5 times, answer questions about symptoms daily, be assigned to take the study product as instructed and provide a stool sample 4 times.

Treatments tested

Tirzepatide also known as Zepbound Drug

Tirzepatide will be administered subcutaneously
Loperamide also known as Imodium Drug

2 mg orally every 6 hours as needed
Diphenoxylate/Atropine also known as Lomotil Drug

2 mg orally every 6 hours

Main thing measured	Proportion of patients achieving a decrease of the average daily bowel frequency by 30% at week 12 (Week 16 if applicable)
Sponsor	University of North Carolina, Chapel Hill
Conditions studied	Pouch, Ileal, Pouches, Ileoanal, Bowel Diseases, Inflammatory
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07756359 ↗