NCT06976853RecruitingPhase 2
Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 30 Apr 2025
- Start date
- 13 May 2025
- Primary completion date
- 31 May 2028
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Crohn's disease
- NCT number
- NCT06976853
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 13 May 2025 to the primary completion date, 31 May 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous diagnosis of anorexia nervosa
- Use of concomitant hypoglycemic agents
- Had intestinal resection ≤ 24 weeks prior to inclusion or other intra-abdominal surgeries ≤ 12 weeks prior to study inclusion
- Active treatment with steroids\*
- Positive stool test for parasites, C. Diff or stool culture for pathologic bacteria within 30 days prior to enrollment
- Impending need for surgery per investigator
- 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
Other illness
- 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
- Type 1 or Type 2 diabetes
- Personal or family history of medullary thyroid carcinoma
- History of multiple endocrine neoplasia
- Known serious hypersensitivity to tirzepatide or any of its excipients
- Have functional or post-operative short-bowel syndrome
Age
- Age \< 18 or \> 80 years
Other
- Pregnant or Breastfeeding female
- BMI \< 25
- Current stricture not passable with an endoscope
- Have an ileostomy or a colostomy
Who the study is looking for
- Subjects 18 to 80 years of age, inclusive, at the time of consent
- Confirmed diagnosis of Crohn's disease based on documented findings on endoscopy and histopathology
- Active ileal or ileocolonic inflammation on colonoscopy defined as
- 1\. Ileal SES-CD \> 4 with ulcer subscore \> 1 (ulcers \> 5mm)
- 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.
- Anti-TNF: Infliximab, Adalimumab, Certolizumab, Golimumab
- Anti-integrin agent: vedolizumab
- Anti-IL12/23 agent: Ustekinumab
- Anti-IL23: Risankizumab, Guselkumab, Mirikizumab
- JAK inhibitor: Upadacitinib
- In post surgical patients, must be at least 6 months post-op with endoscopic evidence of ileal disease
- In females: compliance to recommended birth control requirements
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Beverly Hills | United States | Not yet recruiting |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.