Enrolling now · NCT06937099

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

What this means for you

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.
Phase Phase 3Sponsor Eli Lilly and CompanyDrug tirzepatideClass GLP-1/GIPSites 35 USEnrollment target 290

What this study is for

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

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

Who can join

Age18 to 70SexAnyBMI27 or higher

Adults 18 to 70, have Crohn's disease, BMI 27+. A site coordinator confirms whether you qualify during a free screening visit. The exact medical requirements are below.

Full medical eligibility (for you and your doctor)verbatim from the registry

This is the exact wording from ClinicalTrials.gov, including clinical measures (lab values, imaging scores). Bring it to your doctor if any of it is unclear.

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 sites across 22 states. Contact a site coordinator directly to start screening.

Alabama1 site
  • Digestive Health Specialists
    Dothan, Alabama
    334-836-1212
California4 sites
  • Smart Cures Clinical Research
    Anaheim, California
  • Cedars-Sinai Medical Center
    Beverly Hills, California
    310-423-4100
  • United Medical Doctors - Los Alamitos
    Los Alamitos, California
    562-430-4449
  • California Medical Research Associates
    Northridge, California
    818-349-1979
Florida6 sites
  • Research Associates of South Florida - Miami - Southwest 8th Street
    Miami, Florida
  • Gastro Health Research - Miami
    Miami, Florida
  • Orlando Health
    Orlando, Florida
  • Digestive and Liver Center of Florida
    Orlando, Florida
    407-384-7388
  • Gastro Health Research - Pensacola
    Pensacola, Florida
  • Precision Clinical Research
    Sunrise, Florida
Idaho1 site
  • Grand Teton Research Group
    Idaho Falls, Idaho
    208-528-4256
Illinois1 site
  • Rush University Medical Center
    Chicago, Illinois
Indiana2 sites
  • Indiana University Health University Hospital
    Indianapolis, Indiana
  • Gastroenterology Health Partners
    New Albany, Indiana
    812-206-1702
Kentucky1 site
  • Gastroenterology Health Partners
    Louisville, Kentucky
    502-888-1988
Louisiana2 sites
  • Care Access - New Iberia
    New Iberia, Louisiana
    813-851-0135
  • Louisiana Research Center
    Shreveport, Louisiana
    318-525-3233
Maryland1 site
  • Capital Digestive Care - Chevy Chase
    Chevy Chase, Maryland
Massachusetts1 site
  • Lucida Clinical Trials
    New Bedford, Massachusetts
Missouri1 site
  • Washington University School of Medicine
    St Louis, Missouri
New Hampshire1 site
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire
New York2 sites
  • New York Gastroenterology Associates
    New York, New York
    212-369-2490
  • Care Access - Yonkers
    Yonkers, New York
North Carolina1 site
  • Coastal Research Institute - Fayetteville
    Fayetteville, North Carolina
Ohio1 site
  • Gastro Intestinal Research Institute of Northern Ohio, LLC
    Westlake, Ohio
Pennsylvania1 site
  • Thomas Jefferson University - Medicine/GI and Hepatology
    Philadelphia, Pennsylvania
    215-955-8900
Rhode Island1 site
  • University Gastroenterology
    Providence, Rhode Island
    401-421-8800
South Carolina1 site
  • Gastroenterology Associates - Patewood
    Greenville, South Carolina
    864-451-5026
Tennessee1 site
  • Gastroenterology Center Of The Midsouth
    Cordova, Tennessee
Texas3 sites
  • Gastroenterology Research of San Antonio
    San Antonio, Texas
    210-615-3848
  • Southern Star Research Institute
    San Antonio, Texas
    210-581-2812
  • Tyler Research Institute
    Tyler, Texas
    903-630-6211
Washington1 site
  • Washington Gastroenterology - Tacoma
    Tacoma, Washington
    253-272-5127
Wisconsin1 site
  • Wisconsin Center for Advanced Research
    Milwaukee, Wisconsin
    414-908-6500

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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