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

NCT06976853 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Parakkal Deepak, MBBS, MS · Washington University School of Medicine GI Division

  • Louis Cohen, MD · Icahn School of Medicine at Mount Sinai

  • Andres Yarur, MD · Cedars-Sinai Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-13
Primary Completion
2028-05-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06976853 on ClinicalTrials.gov