RecruitingPhase 2NCT06976853

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


Sponsor

Washington University School of Medicine

Enrollment

60 participants

Start Date

May 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a medication called tirzepatide (a GLP-1/GIP receptor agonist, the same type of drug as Mounjaro) in people with Crohn's disease whose symptoms have not improved despite trying multiple standard treatments. Researchers want to see whether this drug can reduce gut inflammation through a different pathway than current therapies. **You may be eligible if...** - You are between 18 and 80 years old - You have a confirmed diagnosis of Crohn's disease affecting the small intestine or large intestine, with active ulcers seen on colonoscopy - Your Crohn's has not responded well to at least 2 different advanced medications (such as biologics like infliximab, vedolizumab, or ustekinumab, or a JAK inhibitor) - If you have had bowel surgery, it must have been at least 6 months ago **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have type 1 or type 2 diabetes, or take blood sugar-lowering medication - Your BMI is below 25 - You have a personal or family history of a specific type of thyroid cancer (medullary thyroid carcinoma) or multiple endocrine neoplasia - You have ulcerative colitis or another type of inflammatory bowel disease - You are currently on steroids - You have had recent intestinal surgery (within the past 6 months) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTirzepatide

Addition of tirzepatide to current biological therapy

DRUGStandard of care treatment

Intervention will be to change patient's current therapy to a 3rd or later advanced biologic patient have never been exposed to


Locations(3)

Cedars-Sinai Medical Center

Beverly Hills, California, United States

Washington University School of Medicine

St Louis, Missouri, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

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NCT06976853


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