A study of a GLP-1 and GIP medicine, tirzepatide, in people with inflammatory bowel disease.
- Who can join
- Adults 18 to 80, have inflammatory bowel disease, BMI 20+.
- What you take
- Tirzepatide, given as part of the study. Check ClinicalTrials.gov for this trial's study groups, including any placebo or comparison medicine.
- How long it lasts
- The study runs about 12 months.
- What you get
- Costs vary by study. Ask the study team what this one covers, including the study medicine, visits and travel, before you sign the consent form.
What this study is for
Primary condition: Pouch, Ileal. Also studied in: Pouches, Ileoanal, Bowel Diseases, Inflammatory.
Full scientific study title: Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008).
Who can join
Adults 18 to 80, have inflammatory bowel disease, BMI 20+. A site coordinator confirms whether you qualify during a free screening visit. The exact medical requirements are below.
Full medical eligibility (for you and your doctor)verbatim from the registry
This is the exact wording from ClinicalTrials.gov, including clinical measures (lab values, imaging scores). Bring it to your doctor if any of it is unclear.
Key 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
Key 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
- 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
Where this trial runs
This trial has 5 sites across 5 states. Site contacts are listed for reference. They are not screening through this trial right now.
California1 site
- Cedars Sinai Medical CenterBeverly Hills, California
Minnesota1 site
- Mayo ClinicRochester, Minnesota
Missouri1 site
- Washington University School of MedicineSt Louis, Missouri
North Carolina1 site
- University of North CarolinaChapel Hill, North Carolina
Utah1 site
- University of UtahSalt Lake City, Utah
Timeline
Scheduled start: September 2026. Expected completion: September 2027. Last updated on ClinicalTrials.gov: August 10, 2026.
Official source
Every Monday we check this trial against ClinicalTrials.gov, the federal registry for clinical research. Last checked September 4, 2026. Confirm the current status there before you contact a site:
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