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RecruitingPhase 3

Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

Eli Lilly and Company · NCT06937099

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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
290
US sites recruiting
35
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 evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight.

The maximum duration of this study is up to 61 weeks.

Being studied: Mirikizumab; Mirikizumab; Tirzepatide; Placebo

Conditions: Crohn's Disease; 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 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
  • obstructive sleep apnea, or
  • cardiovascular disease.
  • Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline.
  • Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for patients with ileal-colonic or ≥4 for patients with isolated ileal disease within 21 days before the first dose of study treatment.
  • Participants with a history of CD for ≥8 years involving only or predominantly the colon must have documented negative results for colorectal dysplasia and cancer within 1 year prior to baseline.
  • Demonstrated inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced CD therapy

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.
  • 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 had more than 5% body weight change in the past 3 months
  • 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

  • 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

  • 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 and Tirzepatide Administered in Adult Participants… (NCT06937099) | Bored Studies