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RecruitingPhase 2

Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "A member of the research team will also use blood samples, stool samples and samples of the small intestine taken during a colonoscopy to understand how tirzepatide helps heal the intestine."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether tirzepatide can help heal the bowel in adults with Crohn’s disease whose small bowel inflammation is hard to treat. Researchers will check symptoms, blood and stool samples, and bowel samples taken during a colonoscopy, a test using a thin tube with a camera.

The purpose of this research study is to evaluate what type of treatment will be beneficial for people with Crohn's disease and difficult to treat inflammation in the small bowel. Current therapies are used to control the inflammation due to Crohn's disease in your digestive tract. In some patients, those therapies are not sufficient to fully treat the disease. This objective of this study is to evaluate the efficacy of a different type of therapy, tirzepatide, that may promote healing of the affected intestinal segment. To evaluate the efficacy of this medication, a member of the research team will ask patients questions about how they feel and observe whether this medication heals the their bowel at colonoscopy. A member of the research team will also use blood samples, stool samples and samples of the small intestine taken during a colonoscopy to understand how tirzepatide helps heal the intestine.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 80 years old.
  • You have Crohn’s disease confirmed by a camera exam of your bowel and tissue tests.
  • A colonoscopy shows active inflammation in the last part of your small bowel, with or without large bowel inflammation. Your small bowel disease score must be above 4, with an ulcer score above 1 and ulcers larger than 5 mm.
  • At least 2 advanced Crohn’s medicines have not worked or have stopped working. For anti-TNF medicines, this must not be due to antibodies your body made against the medicine.
  • Your latest treatment has been adjusted for the best effect for at least 6 months, without steroid medicines.
  • If you have had surgery, it was at least 6 months ago, and a camera exam shows disease in the last part of your small bowel.
  • If you are female, you must follow the study’s birth control requirements.

Who can't join

  • You are under 18 or over 80, are pregnant or breastfeeding, or will not follow the required birth control rules.
  • You have another listed type of colitis (large bowel inflammation), severe swelling of the large bowel, or a positive stool test for certain infections. Some stool test limits apply to the 30 days before joining.
  • Your body mass index (BMI), a measure based on height and weight, is below 25, or you have or have had anorexia nervosa, an eating disorder.
  • You have type 1 or type 2 diabetes, take medicines that lower blood sugar, or are currently taking steroids.
  • You or a family member has had medullary thyroid cancer, or you have had multiple endocrine neoplasia, a condition that causes tumors in hormone-making glands.
  • You have a known serious allergy to tirzepatide or any of its ingredients.
  • You have short-bowel syndrome, meaning too little working small bowel; had part of your bowel removed within 24 weeks; or had other surgery inside your belly within 12 weeks before joining.
  • Your bowel is too narrow for the exam camera to pass, the study doctor thinks you will soon need surgery, or you have an ileostomy or colostomy, an opening in your belly for stool to leave the body.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Subjects 18 to 80 years of age, inclusive, at the time of consent 2. Confirmed diagnosis of Crohn's disease based on documented findings on endoscopy and histopathology 3. Active ileal or ileocolonic inflammation on colonoscopy defined as 1\. Ileal SES-CD \> 4 with ulcer subscore \> 1 (ulcers \> 5mm) 4. Failure to respond to (primary or secondary non-response) at least 2 advanced class drugs, without evidence of immunogenicity (anti-TNFa only). Must have been at least 6 months optimized on most recent therapy without corticosteroids. 1. Anti-TNF: Infliximab, Adalimumab, Certolizumab, Golimumab 2. Anti-integrin agent: vedolizumab 3. Anti-IL12/23 agent: Ustekinumab 4. Anti-IL23: Risankizumab, Guselkumab, Mirikizumab 5. JAK inhibitor: Upadacitinib 5. In post surgical patients, must be at least 6 months post-op with endoscopic evidence of ileal disease 6. In females: compliance to recommended birth control requirements Exclusion Criteria: 1. Age \< 18 or \> 80 years 2. Pregnant or Breastfeeding female 3. Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease-associated colitis, toxic megacolon, active infectious colitis or positive test for Clostridioides Difficile toxin at screening 4. BMI \< 25 5. Current or previous diagnosis of anorexia nervosa 6. Type 1 or Type 2 diabetes 7. Use of concomitant hypoglycemic agents 8. Personal or family history of medullary thyroid carcinoma 9. History of multiple endocrine neoplasia 10. Known serious hypersensitivity to tirzepatide or any of its excipients 11. Have functional or post-operative short-bowel syndrome 12. Had intestinal resection ≤ 24 weeks prior to inclusion or other intra-abdominal surgeries ≤ 12 weeks prior to study inclusion 13. Active treatment with steroids\* 14. Positive stool test for parasites, C. Diff or stool culture for pathologic bacteria within 30 days prior to enrollment 15. Current stricture not passable with an endoscope 16. Impending need for surgery per investigator 17. Have an ileostomy or a colostomy 18. In females: refusal to comply to recommended birth control requirements \*Corticosteroids have metabolic and hormonal effects which we are concerned may interfere with study outcomes and metabolic changes in the population. This exclusion criteria will allow the study population to be standardized across all patients

Study sites (3)

CA

MO

NY