NCT06976853

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn Disease (CD)

Interventions

Type	Name	Description
DRUG	Tirzepatide	Addition of tirzepatide to current biological therapy
DRUG	Standard 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

Timeline

• Start date: 2025-05-13
• Primary completion: 2028-05-01
• Completion: 2028-08-01
• First posted: 2025-05-16
• Last updated: 2025-06-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study