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

NCT07756359 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-10

No results posted yet for this study

Summary

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.

Conditions

  • Pouch, Ileal
  • Pouches, Ileoanal
  • Bowel Diseases, Inflammatory

Interventions

DRUG

Tirzepatide

Tirzepatide will be administered subcutaneously

DRUG

Loperamide

2 mg orally every 6 hours as needed

DRUG

Diphenoxylate/Atropine

2 mg orally every 6 hours

Sponsors & Collaborators

Principal Investigators

  • Edward Barnes, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07756359 on ClinicalTrials.gov