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

What is the Purpose of this Study?

The purpose of this study is to evaluate the effectiveness of an experimental drug called tirzepatide for the treatment of Crohn’s disease. Participants will be randomly assigned to 1 of 2 groups. Group 1 will add tirzepatide to their current therapy, and Group 2 will be offered to change to a 3rd advanced therapy, which is standard of care. Participants in the tirzepatide group will provide blood and stool samples, complete DEXA scans, and receive injections of tirzepatide. Tirzepatide may promote healing of the gastrointestinal tract; it is approved by the U.S. Food and Drug Administration (FDA) in patients with diabetes or obesity, but its use in this study is considered experimental.

Eligibility

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

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

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

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

Study Details

Disease Type/Condition

Other

Principal Investigator

Yarur, Andres

Age Group

Adult

Phase

IRB Number

STUDY00003977

ClinicalTrials.gov ID

NCT06976853

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org