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RecruitingPhase 3

Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study

Eli Lilly and Company · NCT06937086

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–70 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
350
US sites recruiting
37
Study start
June 26, 2025
Record last updated
October 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight.

Participation in this study will last up to 61 weeks, including 52 weeks of treatment.

Being studied: Mirikizumab; Mirikizumab; Tirzepatide; Placebo

Conditions: Ulcerative Colitis; Obesity or Overweight

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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:
  • hypertension
  • Type 2 Diabetes Mellitus (T2DM)
  • dyslipidemia
  • obstructive sleep apnea, or
  • cardiovascular disease.
  • Have an inadequate response to, loss of response to, or intolerance to at least 1 of the conventional medication: oral corticosteroids, oral azathioprine (AZA) or 6-mercaptopurine (6-MP), or oral 5-aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, and balsalazide) and/or who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF) antibodies; anti-integrin antibodies, Janus kinase (JAK) inhibitors such as tofacitinib or upadacitinib, sphingosine 1-phosphate receptor 1inhibitors such as etrasimod or ozanimod, or anti-interleukin(IL)-12p40 antibodies, for example, ustekinumab.

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.
  • Have evidence of toxic megacolon, or stricture or stenosis within the colon that cannot be traversed by a sigmoidoscope or colonoscope.
  • Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.
  • Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening.
  • Have a self-reported change in body weight greater than 5% (gain or reduction) within 3 months prior to screening.
  • Have a current or recent acute, active infection.

Recruiting US locations

  • Digestive Health Specialists

    Dothan, AL 36301

    Site contact: 334-836-1212

  • Smart Cures Clinical Research

    Anaheim, CA 92806

    Site contact: Dennis Riff

  • Cedars-Sinai Medical Center

    Beverly Hills, CA 90211

    Site contact: 310-423-4100

  • United Medical Doctors - Los Alamitos

    Los Alamitos, CA 90720

    Site contact: 562-430-4449

  • California Medical Research Associates

    Northridge, CA 91324

    Site contact: 818-349-1979

  • Research Associates of South Florida - Miami - Southwest 8th Street

    Miami, FL 33134

    Site contact: Alexander Veloso

  • Gastro Health Research - Miami

    Miami, FL 33176

    Site contact: Lukasz Kwapisz

  • Orlando Health

    Orlando, FL 32806

    Site contact: Udayakumar Navaneethan

  • Digestive and Liver Center of Florida

    Orlando, FL 32825

    Site contact: 407-384-7388

  • Gastro Health Research - Pensacola

    Pensacola, FL 32504

    Site contact: Frederic Newman

  • Precision Clinical Research

    Sunrise, FL 33351

    Site contact: Jeffrey Schneider

  • Grand Teton Research Group

    Idaho Falls, ID 83404

    Site contact: 208-528-4256

  • Rush University Medical Center

    Chicago, IL 60612

    Site contact: Atsushi Sakuraba

  • Indiana University Health University Hospital

    Indianapolis, IN 46202

    Site contact: Monika Fischer

  • Gastroenterology Health Partners

    New Albany, IN 47150

    Site contact: 812-206-1702

  • Gastroenterology Health Partners

    Louisville, KY 40218

    Site contact: 502-888-1988

  • Care Access - New Iberia

    New Iberia, LA 70560

    Site contact: 813-851-0135

  • Louisiana Research Center

    Shreveport, LA 71105

    Site contact: 318-525-3233

  • Capital Digestive Care - Chevy Chase

    Chevy Chase, MD 20815

    Site contact: Erica Cohen

  • Lucida Clinical Trials

    New Bedford, MA 02740

    Site contact: Paul Sepe

  • Washington University School of Medicine

    St Louis, MO 63110

    Site contact: Parakkal Deepak

  • Dartmouth-Hitchcock Medical Center

    Lebanon, NH 03756

    Site contact: Corey Siegel

  • Icahn School of Medicine at Mount Sinai

    New York, NY 10029

    Site contact: Stephanie Gold

  • New York Gastroenterology Associates

    New York, NY 10075

    Site contact: 212-369-2490

  • Care Access - Yonkers

    Yonkers, NY 10701

    Site contact: Peter Wayne

  • Coastal Research Institute - Fayetteville

    Fayetteville, NC 28304

    Site contact: John Poulos

  • Gastro Intestinal Research Institute of Northern Ohio, LLC

    Westlake, OH 44145

    Site contact: Mousab Tabbaa

  • Thomas Jefferson University - Medicine/GI and Hepatology

    Philadelphia, PA 19107

    Site contact: 215-955-8900

  • University Gastroenterology

    Providence, RI 02905

    Site contact: 401-421-8800

  • Gastroenterology Associates - Patewood

    Greenville, SC 29607

    Site contact: 864-451-5026

  • Gastroenterology Center Of The Midsouth

    Cordova, TN 38018

    Site contact: Ziad Younes

  • Gastroenterology Research of San Antonio

    San Antonio, TX 78229

    Site contact: 210-615-3848

  • Southern Star Research Institute

    San Antonio, TX 78229

    Site contact: 210-581-2812

  • Tyler Research Institute

    Tyler, TX 75701

    Site contact: 903-630-6211

  • Gastroenterology Consultants of Southwest Virginia

    Roanoke, VA 24014

    Site contact: Nirish Shah

  • Washington Gastroenterology - Tacoma

    Tacoma, WA 98405

    Site contact: 253-272-5127

  • Wisconsin Center for Advanced Research

    Milwaukee, WI 53215

    Site contact: 414-908-6500

Study contacts (from the official record)

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
  • Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
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Mirikizumab Administered at the Same Time as Tirzepatide in Adult… (NCT06937086) | Bored Studies