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Weight-Loss drug zepbound studied as Crohn's treatment

NCT ID NCT06774079

Disease control Sponsor: University of Miami Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether the weight-loss drug tirzepatide (Zepbound) combined with a Mediterranean diet can help control mild Crohn's disease. Twenty-four adults with Crohn's who are already on biologic therapy and have a BMI of 27 or higher will receive either tirzepatide injections plus dietary guidance or standard care. The main goal is to see if participants stick with the treatment and diet, not yet to measure symptom improvement.

What this could mean

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

Active substance
tirzepatide (Zepbound)
What this could lead to
If it works, this could point toward a new way to manage Crohn's symptoms using weight loss and diet alongside standard biologic therapy.
What could go wrong
This is a very small pilot study (24 people) focused on feasibility, not effectiveness. It may not show clear benefits, and tirzepatide can cause gastrointestinal side effects that could worsen Crohn's symptoms.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 24 people

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

Started

Mar 2025

Expected to finish

Mar 2027

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 years and older

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: * Adult patients (≥18 years old) * Confirmed diagnosis of Crohn's disease * Mildly active disease, defined by clinical symptoms using the Harvey Bradshaw Index (HBI) score between 5 and 7 (the HBI is a continuous score ranging from 0-16 where \<4 is considered remission) * BMI ≥ 27 kg/m2 * Patients will be on stable doses of medical therapy (anti-tumor necrosis factor (TNF) alpha blockers) Exclusion Criteria: * Patients under 18 years of age * Patients with ulcerative colitis * Patients with infectious colitis * BMI\<27 kg/m2 * Patients with type 1 or type 2 diabetes * Contraindications to a GIP/GLP-1 RA, including patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2 * Patients already on GIP/GLP-1 RA therapy * Patients with the following chronic symptoms: severe constipation, nausea, and/or vomiting * Patients with the following medical history: small bowel obstruction in the last year, intestinal stricture, known or suspected diagnosis of gastroparesis * Adults unable to consent * Pregnant patients (will be confirmed via a pregnancy test) * Prisoners

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease

As listed by the trial registrant

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

Crohn disease

How to take part

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

  1. The places running it

    1 site. 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

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

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