Phase 2 Crohn's Disease and Colitis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People aged 18 to 80 years old at the time of signing consent
- People who have a confirmed diagnosis of Crohn's disease, supported by findings from a camera examination of the bowel (endoscopy) and tissue samples (histopathology)
- People who have active inflammation in the small intestine or small and large intestine, confirmed by a specific scoring system on endoscopy that shows ulcers larger than 5mm
- People whose Crohn's disease has not responded to at least 2 different advanced treatments from recognised drug classes (including anti-TNF biologics, vedolizumab, ustekinumab, anti-IL-23 biologics, or the JAK inhibitor upadacitinib), where the most recent treatment was tried for at least 6 months without the use of steroids, and where any anti-TNF failure was not due to the body developing antibodies against the drug
- People who have had bowel surgery must be at least 6 months post-surgery and must have endoscopic evidence of disease in the small intestine
- Women of childbearing potential who are willing to follow the trial's recommended birth control requirements
Who may not be able to join:
- People under 18 or over 80 years of age
- Women who are pregnant or breastfeeding
- People diagnosed with other bowel conditions such as ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease-associated colitis, toxic megacolon, active infectious colitis, or who test positive for a bowel infection called Clostridioides difficile at the screening visit
- People with a BMI (body mass index) below 25
- People with a current or previous diagnosis of anorexia nervosa
- People with Type 1 or Type 2 diabetes
- People currently using blood sugar-lowering medications
- People with a personal or family history of a specific type of thyroid cancer called medullary thyroid carcinoma
- People with a history of a condition called multiple endocrine neoplasia (a disorder affecting hormone-producing glands)
- People with a known serious allergic reaction to the study drug tirzepatide or any of its ingredients
- People who have a condition where the bowel cannot absorb food properly due to its shortened length (short-bowel syndrome), whether from surgery or other causes
- People who had bowel surgery within the past 24 weeks, or any other abdominal surgery within the past 12 weeks
- People currently being treated with steroid medications
- People who have tested positive for parasites, C. difficile, or harmful bacteria in a stool test within the 30 days before enrolling
- People who have a bowel narrowing (stricture) that a camera cannot pass through
- People whose doctor considers surgery to be needed in the near future
- People who have an ileostomy or colostomy (a surgically created opening in the abdomen for waste removal)
- Women who are not willing to follow the trial's recommended birth control requirements
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Parakkal Deepak, MBBS, MS, Washington University School of Medicine GI Division
Phone: 314-362-9044
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Proportion and number of participants who have treatment emergent adverse events, serious adverse events, discontinuation of study intervention due to adverse events and injection-site reactions by CTCAE v4.0; Number of participants who achieve various doses of Tirzepatide at increments of 2.5 mg, up to 15 mg; Proportion and number of participants with endoscopic remission as defined by SES-CD < 4 with no ulcer subscore >1.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.