A study testing whether a new weekly shot from Lilly, tirzepatide, can calm gut inflammation.

Who can join

Adults 18 to 70, have Crohn's disease, BMI 27+.

What you take

tirzepatide, given as part of the study at no cost to you. Some participants may receive a placebo (an inactive version) instead, decided at random.

How long it lasts

The full study runs about 2.9 years; your own time in it is usually shorter.

What you get

The study medication and study-related care at no cost. Compensation varies by study site; many cover travel and provide the study medication at no cost. The trial coordinator will explain what that site offers before you join.

What this study is for

Full study title: Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight.

Primary condition: Crohn's Disease. Also studied in: Obesity or Overweight.

Who can join, in detail

Key inclusion criteria

• Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD
• Have obesity body mass index 30 kilograms per meter squared (BMI >=30 kg/m²), or overweight (BMI >=27 kg/m2 to <30 kg/m²) and in the presence of at least 1 weight-related comorbid conditions:
• hypertension
• Type 2 diabetes mellitus (T2DM)
• dyslipidemia

Key exclusion criteria

• Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis.
• Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum.
• Currently have or are suspected to have an abscess.
• Have a stoma, ileoanal pouch, or ostomy.
• Have a history of more than 3 small bowel resections, total resection of small bowel greater than 100 centimeters (cm), diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline.

Where this study is enrolling

This trial has 35 US sites across 22 states. Contact the site coordinator directly to start the screening process.

Timeline

Started enrolling: 2025-06-26. Expected completion: 2028-05. Last updated on ClinicalTrials.gov: 2026-05-20.

Official source

We sync this data quarterly from ClinicalTrials.gov, the federal registry for clinical research. Before contacting a site, verify the trial is still recruiting on the official page:

View on ClinicalTrials.gov →

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