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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Washington University School of Medicine
Study ID
NCT06976853
Phase
PHASE2
Status
Recruiting
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Conditions

  • Crohn Disease (CD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Addition of tirzepatide to current biological therapy
  • Standard of care treatment — DRUG
    Intervention will be to change patient's current therapy to a 3rd or later advanced biologic patient have never been exposed to

Study Details

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.

Key Dates

Start date
May 13, 2025
Status verified
Jun 2026
Primary completion
May 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide group
  • Active Comparator: Standard of Care Arm

Primary Outcome Measure

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 v4.0 [ Time Frame: From enrollment to the end of treatment at month 7 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterBeverly HillsCalifornia90211
Martha Bucaram
[email protected]
310-423-0035
Andres Yarur, MD (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110
Monique Lavalas Bright
[email protected]
314-362-9044
Parakkal Deepak, MBBS, MS (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Katha Makwana
[email protected]
212-327-8270
Louis Cohen, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Cedars-Sinai Medical Center· Beverly Hills, CAWashington University School of Medicine· St Louis, MOIcahn School of Medicine at Mount Sinai· New York, NY

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