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Could a diabetes drug heal Crohn's gut damage?

NCT ID NCT06976853

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests tirzepatide, a drug used for diabetes, in 60 adults with Crohn's disease who have active inflammation in the small bowel despite other treatments. The goal is to see if tirzepatide can heal the gut lining better than switching to another standard biologic therapy. Researchers will check healing via colonoscopy and track side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tirzepatide
What this could lead to
If successful, tirzepatide could offer a new option for healing intestinal damage in Crohn's disease patients who don't respond to current treatments.
What could go wrong
This is an early Phase 2 trial with only 60 participants, so results may not apply to everyone. Tirzepatide may cause side effects like injection-site reactions or gastrointestinal issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects 18 to 80 years of age, inclusive, at the time of consent 2. Confirmed diagnosis of Crohn's disease based on documented findings on endoscopy and histopathology 3. Active ileal or ileocolonic inflammation on colonoscopy defined as 1\. Ileal SES-CD \> 4 with ulcer subscore \> 1 (ulcers \> 5mm) 4. Failure to respond to (primary or secondary non-response) at least 2 advanced class drugs, without evidence of immunogenicity (anti-TNFa only). Must have been at least 6 months optimized on most recent therapy without corticosteroids. 1. Anti-TNF: Infliximab, Adalimumab, Certolizumab, Golimumab 2. Anti-integrin agent: vedolizumab 3. Anti-IL12/23 agent: Ustekinumab 4. Anti-IL23: Risankizumab, Guselkumab, Mirikizumab 5. JAK inhibitor: Upadacitinib 5. In post surgical patients, must be at least 6 months post-op with endoscopic evidence of ileal disease 6. In females: compliance to recommended birth control requirements Exclusion Criteria: 1. Age \< 18 or \> 80 years 2. Pregnant or Breastfeeding female 3. Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease-associated colitis, toxic megacolon, active infectious colitis or positive test for Clostridioides Difficile toxin at screening 4. BMI \< 25 5. Current or previous diagnosis of anorexia nervosa 6. Type 1 or Type 2 diabetes 7. Use of concomitant hypoglycemic agents 8. Personal or family history of medullary thyroid carcinoma 9. History of multiple endocrine neoplasia 10. Known serious hypersensitivity to tirzepatide or any of its excipients 11. Have functional or post-operative short-bowel syndrome 12. Had intestinal resection ≤ 24 weeks prior to inclusion or other intra-abdominal surgeries ≤ 12 weeks prior to study inclusion 13. Active treatment with steroids\* 14. Positive stool test for parasites, C. Diff or stool culture for pathologic bacteria within 30 days prior to enrollment 15. Current stricture not passable with an endoscope 16. Impending need for surgery per investigator 17. Have an ileostomy or a colostomy 18. In females: refusal to comply to recommended birth control requirements \*Corticosteroids have metabolic and hormonal effects which we are concerned may interfere with study outcomes and metabolic changes in the population. This exclusion criteria will allow the study population to be standardized across all patients

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cedars-Sinai Medical Center

    NOT_YET_RECRUITING

    Beverly Hills, California, 90211, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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