Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)
Phase 4 · Testing Tirzepatide, Loperamide and Diphenoxylate/Atropine · 5 sites · University of North Carolina, Chapel Hill
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Tirzepatide (a drug), Loperamide (a drug) and Diphenoxylate/Atropine (a drug) as a possible treatment. Condition(s) listed: Pouch, Ileal, Pouches, Ileoanal and Bowel Diseases, Inflammatory.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 to 80
- Any sex
Some of the main requirements, copied from the record:
- Informed consent will be obtained before any study-related procedures
- Age > 18 and <80 years
- Patients with an IPAA and bowel frequency > 8 bowel movements in 24 hours on at least 4 of 7 days/week (and/or an average of >8 bowel movements in the 7 days preceding enrollment)
Plus 4 more requirement(s). There are also 22 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 20 participants are expected to take part.
- Start date: 2026-09 (planned).
- Main results expected around 2027-09 (estimate from the record).
- 5 study sites listed in United States.
Main thing being measured
- Proportion of patients achieving a decrease of the average daily bowel frequency by 30% at week 12 (Week 16 if applicable) (Week 12 (Week 16 if applicable))
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Pouch, Ileal; Pouches, Ileoanal; Bowel Diseases, Inflammatory |
| Lead sponsor | University of North Carolina, Chapel Hill |
| Collaborators | Eli Lilly and Company |
| Enrollment | 20 (estimated) |
| Start date | 2026-09 |
| Primary completion (est.) | 2027-09 |
| First posted | 2026-08-10 |
| Last updated | 2026-08-10 |
| 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) |
| ClinicalTrials.gov ID | NCT07756359 |
Interventions
- Tirzepatide (Drug)
Tirzepatide will be administered subcutaneously - Loperamide (Drug)
2 mg orally every 6 hours as needed - Diphenoxylate/Atropine (Drug)
2 mg orally every 6 hours
Full eligibility criteria (from the record)
Inclusion Criteria: * Informed consent will be obtained before any study-related procedures * Age > 18 and <80 years * Patients with an IPAA and bowel frequency > 8 bowel movements in 24 hours on at least 4 of 7 days/week (and/or an average of >8 bowel movements in the 7 days preceding enrollment) * Patients must have demonstrated high bowel frequency despite adequate therapy for high bowel frequency with loperamide 2 mg orally every 6 hours as needed (at least 3 doses daily) and/or diphenoxylate/atropine 2 mg orally every 6 hours as needed (at least 3 doses daily) or proven intolerance to these anti-diarrheal medications. * Among patients with inflammatory conditions of the pouch, high bowel frequency must be demonstrated despite adequate therapy for intermittent pouchitis, chronic pouchitis, or Crohn's like disease of the pouch. Adequate therapy is required to ensure significant pouch inflammation is not a driver of high bowel frequency (described in Exclusion Criteria). * 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 Exclusion Criteria: * Prior exposure to tirzepatide or other GLP-1RA * BMI <20 at the time of study screening * Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 * Known hypersensitivity to tirzepatide or its metabolites * Significant pouch inflammation defined as an endoscopic pouch disease activity index (PDAI ) ≥ 4 * Known stricture of the ileo-anal anastomosis or afferent limb stricture * New onset of high bowel frequency in the setting of acute pouchitis * Final stage of IPAA surgery < 6 months prior to enrollment * Current infection with Clostridioides difficile * Known HIV or active Hepatitis B/C * Clinically significant liver disease (Primary Sclerosing Cholangitis with LFT's <1.5 upper limit of normal can be included) * Severe hepatic impairment, defined as Child-Pugh Class C * Known clinically significant chronic nausea and/or vomiting in the past * Known diagnosis of type 1 or type 2 diabetes * Known decreased kidney function with a glomerular filtration rate <30 ml/min/1.732 * History of malignancy, except for basal cell carcinoma, non-metastatic squamous cell carcinoma of the skin, or prior malignancy with curative therapy completed at least 5 years prior to screening and no recurrence. * New York Heart Association class 3 or greater heart failure or recent (within 6 months) cardiovascular event * Prior history of pancreatitis * Clinically significant laboratory results at screening or baseline, as judged by the Investigator from local testing. * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. * Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. * Any disorder, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
Locations (5)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.