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HomeTrials › NCT06937086

Obesity & weight · Phase 3 · Recruiting now

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

NCT06937086 · Sponsor: Eli Lilly and Company

What this trial means for you

This study is recruiting now at 37 US sites. It's studying Mirikizumab, Mirikizumab, Tirzepatide, Placebo for ulcerative colitis, 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 participants350
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 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.

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 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.

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 · Recruiting now

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

  • Icahn School of Medicine at Mount Sinai — New York · Recruiting now
  • 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

Virginia

  • Gastroenterology Consultants of Southwest Virginia — Roanoke · 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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