Actively Recruiting
Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease
Led by Washington University School of Medicine · Updated on 2025-06-11
60
Participants Needed
3
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years at the time of consent
- Confirmed diagnosis of Crohn's disease based on endoscopy and histopathology
- Active ileal or ileocolonic inflammation on colonoscopy with SES-CD > 4 and ulcer subscore > 1
- Failure to respond to at least 2 advanced class drugs without immunogenicity, with at least 6 months optimized on most recent therapy without corticosteroids
- At least 6 months post-operative with endoscopic evidence of ileal disease for post-surgical patients
- Female participants must comply with recommended birth control requirements
You will not qualify if you...
- Age under 18 or over 80 years
- Pregnant or breastfeeding female
- Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease-associated colitis, toxic megacolon, active infectious colitis or positive Clostridioides Difficile toxin test at screening
- Body mass index (BMI) less than 25
- Current or previous diagnosis of anorexia nervosa
- Type 1 or Type 2 diabetes
- Use of hypoglycemic agents
- Personal or family history of medullary thyroid carcinoma
- History of multiple endocrine neoplasia
- Known serious hypersensitivity to tirzepatide or its components
- Functional or post-operative short-bowel syndrome
- Intestinal resection within 24 weeks prior to inclusion or other intra-abdominal surgeries within 12 weeks prior to inclusion
- Active treatment with steroids
- Positive stool test for parasites, C. Diff, or bacteria within 30 days prior to enrollment
- Current intestinal stricture not passable with an endoscope
- Impending need for surgery
- Presence of ileostomy or colostomy
- Female refusal to comply with recommended birth control requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Cedars-Sinai Medical Center
Beverly Hills, California, United States, 90211
Not Yet Recruiting
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
3
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
M
Monique Lavalas Bright
CONTACT
D
Darren Nix
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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