Tirzepatide for Crohn's Disease

Recruiting at 2 trial locations

Overseen By Darren Nix

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Must not be taking: Hypoglycemic agents, Corticosteroids

Disqualifiers: Ulcerative colitis, Diabetes, Thyroid carcinoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Parakkal Deepak, MBBS, MS

Principal Investigator

Washington University School of Medicine GI Division

Andres Yarur, MD

Principal Investigator

Cedars-Sinai Medical Center

Louis Cohen, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for adults aged 18-80 with Crohn's disease who have active inflammation in the small bowel and haven't responded to at least two advanced drugs. They must not be pregnant, breastfeeding, or have a BMI under 25. Participants need to agree to birth control requirements if applicable.

Inclusion Criteria

Active ileal or ileocolonic inflammation on colonoscopy defined as Ileal SES-CD > 4 with ulcer subscore > 1 (ulcers > 5mm)

In females: compliance to recommended birth control requirements

I have been diagnosed with Crohn's disease through tests.

Exclusion Criteria

BMI < 25

I am currently pregnant or breastfeeding.

Positive stool test for parasites, C. Diff, or stool culture for pathologic bacteria within 30 days prior to enrollment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tirzepatide to evaluate its efficacy in promoting healing of the affected intestinal segment

8-12 weeks

Regular visits for colonoscopy and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tirzepatide

Trial Overview The study compares standard treatments for Crohn's disease with Tirzepatide, focusing on healing inflamed intestinal segments. It involves interviews about patient well-being, colonoscopy observations, and analysis of blood and stool samples.

Participant Groups

Group I: Tirzepatide group Experimental Treatment 1 Intervention

Group II: Standard of Care Arm Active Control 1 Intervention

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+