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HomeTrials › NCT06937099

Obesity & weight · Phase 3 · Recruiting now

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

NCT06937099 · Sponsor: Eli Lilly and Company

What this trial means for you

This study is recruiting now at 35 US sites. It's studying Mirikizumab, Mirikizumab, Tirzepatide, Placebo for crohn's disease, obesity or overweight.

Who can joinAll sexes, 18 Years – 70 Years
Healthy volunteersNo — diagnosis required
What you'd takeMirikizumab, Mirikizumab, Tirzepatide, Placebo
Study length~2.8 years overall
Planned participants290
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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.

Study sites by state

Alabama

  • Digestive Health Specialists — Dothan · Recruiting now

California

  • Smart Cures Clinical Research — Anaheim · Recruiting now
  • Cedars-Sinai Medical Center — Beverly Hills · Opening soon
  • United Medical Doctors - Los Alamitos — Los Alamitos · Recruiting now
  • California Medical Research Associates — Northridge · Recruiting now

Florida

  • Research Associates of South Florida - Miami - Southwest 8th Street — Miami · Recruiting now
  • Gastro Health Research - Miami — Miami · Recruiting now
  • Orlando Health — Orlando · Recruiting now
  • Digestive and Liver Center of Florida — Orlando · Recruiting now
  • Gastro Health Research - Pensacola — Pensacola · Recruiting now
  • Precision Clinical Research — Sunrise · Recruiting now

Idaho

  • Grand Teton Research Group — Idaho Falls · Recruiting now

Illinois

  • Rush University Medical Center — Chicago · Opening soon

Indiana

  • Indiana University Health University Hospital — Indianapolis · Recruiting now
  • Gastroenterology Health Partners — New Albany · Recruiting now

Kentucky

  • Gastroenterology Health Partners — Louisville · Recruiting now

Louisiana

  • Care Access - New Iberia — New Iberia · Recruiting now
  • Louisiana Research Center — Shreveport · Recruiting now

Maryland

  • Capital Digestive Care - Chevy Chase — Chevy Chase · Recruiting now

Massachusetts

  • Lucida Clinical Trials — New Bedford · Recruiting now

Missouri

  • Washington University School of Medicine — St Louis · Recruiting now

New Hampshire

  • Dartmouth-Hitchcock Medical Center — Lebanon · Recruiting now

New York

  • New York Gastroenterology Associates — New York · Recruiting now
  • Care Access - Yonkers — Yonkers · Recruiting now

North Carolina

  • Coastal Research Institute - Fayetteville — Fayetteville · Recruiting now

Ohio

  • Gastro Intestinal Research Institute of Northern Ohio, LLC — Westlake · Recruiting now

Pennsylvania

  • Thomas Jefferson University - Medicine/GI and Hepatology — Philadelphia · Recruiting now

Rhode Island

  • University Gastroenterology — Providence · Recruiting now

South Carolina

  • Gastroenterology Associates - Patewood — Greenville · Recruiting now

Tennessee

  • Gastroenterology Center Of The Midsouth — Cordova · Recruiting now

Texas

  • Gastroenterology Research of San Antonio — San Antonio · Recruiting now
  • Southern Star Research Institute — San Antonio · Recruiting now
  • Tyler Research Institute — Tyler · Recruiting now

Washington

  • Washington Gastroenterology - Tacoma — Tacoma · Recruiting now

Wisconsin

  • Wisconsin Center for Advanced Research — Milwaukee · Recruiting now

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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