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NOT YET RECRUITING
NCT07756359
PHASE4

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

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

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.

Official title: Efficacy of the Dual GIP - GLP-1 Receptor Agonist Tirzepatide in Patients With an Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-09

Completion Date

2027-09

Last Updated

2026-08-10

Healthy Volunteers

No

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

Locations (5)

Cedars Sinai Medical Center

Beverly Hills, California, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of North Carolina

Chapel Hill, North Carolina, United States

University of Utah

Salt Lake City, Utah, United States