Enrolling now · NCT06937086

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

Who can join
Adults 18 to 70, have ulcerative colitis, 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 2.8 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 37 USEnrollment target 350

What this study is for

Full study title: Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obe.

Primary condition: Ulcerative Colitis. Also studied in: Obesity or Overweight.

Who can join, in detail

Age 18 to 70
Sex All
BMI 27+

Key inclusion criteria

  • Have had an established diagnosis of UC for >=3 months before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC.
  • Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and endoscopic subscore (ES) of 2 to 3 (confirmed by central review) within 21 days before baseline.
  • Participants with a history of UC for greater than or equal to 8 years who have had a surveillance colonoscopy completed within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.
  • Have obesity, [body mass index (BMI) 30 kilograms per meter squared (kg/m2)]
  • Have overweight (BMI >=27 kg/m2 to <30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions:

Key exclusion criteria

  • Have a current diagnosis of:
  • Crohn's disease
  • inflammatory bowel disease (IBD) unclassified (formerly known as indeterminate colitis), or
  • primary sclerosing cholangitis.
  • Have had or will need bowel resection or intestinal or intra-abdominal surgery.

Where this study is enrolling

This trial has 37 US sites across 23 states. Contact the site coordinator directly to start the screening process.

Alabama

  • Digestive Health Specialists
    Dothan, Alabama
    334-836-1212

California

  • 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

Florida

  • 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

Idaho

  • Grand Teton Research Group
    Idaho Falls, Idaho
    208-528-4256

Illinois

  • Rush University Medical Center
    Chicago, Illinois

Indiana

  • Indiana University Health University Hospital
    Indianapolis, Indiana
  • Gastroenterology Health Partners
    New Albany, Indiana
    812-206-1702

Kentucky

  • Gastroenterology Health Partners
    Louisville, Kentucky
    502-888-1988

Louisiana

  • Care Access - New Iberia
    New Iberia, Louisiana
    813-851-0135
  • Louisiana Research Center
    Shreveport, Louisiana
    318-525-3233

Maryland

  • Capital Digestive Care - Chevy Chase
    Chevy Chase, Maryland

Massachusetts

  • Lucida Clinical Trials
    New Bedford, Massachusetts

Missouri

  • Washington University School of Medicine
    St Louis, Missouri

New Hampshire

  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire

New York

  • Icahn School of Medicine at Mount Sinai
    New York, New York
  • New York Gastroenterology Associates
    New York, New York
    212-369-2490
  • Care Access - Yonkers
    Yonkers, New York

North Carolina

  • Coastal Research Institute - Fayetteville
    Fayetteville, North Carolina

Ohio

  • Gastro Intestinal Research Institute of Northern Ohio, LLC
    Westlake, Ohio

Pennsylvania

  • Thomas Jefferson University - Medicine/GI and Hepatology
    Philadelphia, Pennsylvania
    215-955-8900

Rhode Island

  • University Gastroenterology
    Providence, Rhode Island
    401-421-8800

South Carolina

  • Gastroenterology Associates - Patewood
    Greenville, South Carolina
    864-451-5026

Tennessee

  • Gastroenterology Center Of The Midsouth
    Cordova, Tennessee

Texas

  • 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

Virginia

  • Gastroenterology Consultants of Southwest Virginia
    Roanoke, Virginia

Washington

  • Washington Gastroenterology - Tacoma
    Tacoma, Washington
    253-272-5127

Wisconsin

  • Wisconsin Center for Advanced Research
    Milwaukee, Wisconsin
    414-908-6500

Timeline

Started enrolling: 2025-06-26. Expected completion: 2028-04. Last updated on ClinicalTrials.gov: 2026-05-12.

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:

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