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Tirzepatide

Mounjaro, Zepbound, LY3298176

Quick Stats
Studies 183
Trials 100
Recruiting PHASE2 INTERVENTIONAL NCT06976853

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

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

Primary Outcomes

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
TimeFrame: From enrollment to the end of treatment at month 7
Description:
Measure: Number of participants who achieve various doses of Tirzepatide at increments of 2.5 mg, up to 15 mg
TimeFrame: From enrollment to the end of treatment at month 7
Description:
Measure: Proportion and number of participants with endoscopic remission as defined by SES-CD < 4 with no ulcer subscore >1.
TimeFrame: From enrollment to the end of treatment at month 7
Description:

Trial Information

NCT ID

NCT06976853

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Washington University School of Medicine

Last Updated

December 15, 2025