Crohn's Disease Study: Tirzepatide for Difficult-to-Treat Inflammation
This study is looking for people with Crohn's disease (CD) who have ongoing inflammation in their small bowel, even with current treatments. The study is testing a medication called tirzepatide, added to your current biological therapy, or a new standard of care treatment. Researchers want to see if tirzepatide can help heal the affected part of your intestine. To join, you must be between 18 and 80 years old with a confirmed diagnosis of Crohn's disease and active inflammation in your small bowel, as shown by an endoscopy (a procedure using a camera to look inside your body). Success in this study means fewer side effects, reaching certain doses of tirzepatide, and achieving endoscopic remission (healing of the bowel lining). The study plans to enroll 60 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 60 participants.
- What's involved
- You would receive either tirzepatide added to your current biological therapy or a new standard of care treatment. Researchers will ask you questions about how you feel and observe if your bowel heals at colonoscopy, from enrollment to the end of treatment at month 7.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures outcomes from enrollment to the end of treatment at month 7.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease
At a glance
Conditions
Where it's being run
3 sites across 3 statesStudy leadership
- Parakkal Deepak, MBBS, MS · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine GI Division
- Louis Cohen, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
- Andres Yarur, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center
Who to contact
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What this trial measures
- 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 v4.0From enrollment to the end of treatment at month 7
- Number of participants who achieve various doses of Tirzepatide at increments of 2.5 mg, up to 15 mgFrom enrollment to the end of treatment at month 7
- Proportion and number of participants with endoscopic remission as defined by SES-CD < 4 with no ulcer subscore >1.From enrollment to the end of treatment at month 7