Crohn'sRecruiting

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

Phase 2 · Testing Tirzepatide and Standard of care treatment · 3 sites · Washington University School of Medicine

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing Tirzepatide (a drug) and Standard of care treatment (a drug) as a possible treatment. Condition(s) listed: Crohn Disease (CD).

Participants are assigned to groups by chance (randomized).

It is open-label: participants know what they are receiving.

Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.

Who can join

Ages 18 to 80
Any sex

Some of the main requirements, copied from the record:

Subjects 18 to 80 years of age, inclusive, at the time of consent
Confirmed diagnosis of Crohn's disease based on documented findings on endoscopy and histopathology
Active ileal or ileocolonic inflammation on colonoscopy defined as

Plus 9 more requirement(s). There are also 18 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 60 participants are expected to take part.
Start date: 2025-05-13.
Main results expected around 2028-05 (estimate from the record).
3 study sites listed (2 marked recruiting) in United States.

Main thing being measured

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… (From enrollment to the end of treatment at month 7)

In the researchers’ words

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.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Phase 2
Study type	Interventional
Conditions	Crohn Disease (CD)
Lead sponsor	Washington University School of Medicine
Enrollment	60 (estimated)
Start date	2025-05-13
Primary completion (est.)	2028-05
First posted	2025-05-16
Last updated	2026-06-05
Official title	Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease
ClinicalTrials.gov ID	NCT06976853

Interventions

Tirzepatide (Drug)
Addition of tirzepatide to current biological therapy
Standard of care treatment (Drug)
Intervention will be to change patient's current therapy to a 3rd or later advanced biologic patient have never been exposed to

Full eligibility criteria (from the record)

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

Locations (3)

Site	City	Country	Site status
Cedars-Sinai Medical Center	Beverly Hills, California	United States	Not yet recruiting
Washington University School of Medicine	St Louis, Missouri	United States	Recruiting
Icahn School of Medicine at Mount Sinai	New York, New York	United States	Recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.