Can a diabetes drug curb chronic Pouch-Related bathroom trips?
NCT ID NCT07756359
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This trial tests whether tirzepatide (Zepbound) can reduce daily bowel frequency in adults with an ileal pouch-anal anastomosis (IPAA) who have chronic high bowel frequency despite standard anti-diarrheal therapy. Participants will be assigned to receive tirzepatide or standard care (loperamide or diphenoxylate/atropine) and will track their symptoms daily. The main goal is to see if tirzepatide helps more people achieve a 30% reduction in bowel movements by week 12.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tirzepatide (Zepbound), a dual GIP and GLP-1 receptor agonist, given as a subcutaneous injection
- What this could lead to
- If effective, tirzepatide could offer a new treatment option to reduce frequent bowel movements and improve quality of life for people living with an ileal pouch.
- What could go wrong
- This is a small early-phase trial, so results may not apply to everyone. Tirzepatide can cause side effects like nausea or digestive issues, and it may not work better than standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cedars Sinai Medical Center
Beverly Hills, California, 90211, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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University of North Carolina
Chapel Hill, North Carolina, 27599, United States
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University of Utah
Salt Lake City, Utah, 84112, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Which scope method spots precancerous polyps best in FAP pouches? a head-to-head trial aims to find out.
- Stem cell shot for Crohn's pouch fistulas shows early promise but study halted
- Stem cell shot for Crohn's fistulas: hope or hype?
- Stem cell shot for pouchitis fails to launch
- Could a simple infusion after bowel surgery cut opioid use and speed recovery?
- New drug trial aims to soothe painful pouchitis