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Clinical Trials in the UK / NCT06937086
Recruiting Phase 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

NCT06937086 · tracked via the Priya Life Science UK tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2025-06-26
Last updated
2026-09-04

Condition(s) studied

Ulcerative ColitisObesity or Overweight

Investigational drug(s) / intervention(s)

MirikizumabMirikizumabTirzepatidePlacebo

Mirikizumab: Administered IV

Mirikizumab: Administered SC

Tirzepatide: Administered SC

Placebo: Administered SC

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (187)

FacilityCityRegionStatus
Digestive Health Specialists Dothan Alabama Recruiting
Smart Cures Clinical Research Anaheim California Recruiting
Cedars-Sinai Medical Center Beverly Hills California Recruiting
United Medical Doctors - Los Alamitos Los Alamitos California Recruiting
California Medical Research Associates Northridge California Recruiting
Research Associates of South Florida - Miami - Southwest 8th Street Miami Florida Recruiting
Gastro Health Research - Miami Miami Florida Recruiting
Orlando Health Orlando Florida Recruiting
Digestive and Liver Center of Florida Orlando Florida Recruiting
Gastro Health Research - Pensacola Pensacola Florida Recruiting
Precision Clinical Research Sunrise Florida Recruiting
Grand Teton Research Group Idaho Falls Idaho Recruiting
Rush University Medical Center Chicago Illinois Recruiting
Indiana University Health University Hospital Indianapolis Indiana Recruiting
Gastroenterology Health Partners New Albany Indiana Recruiting
Gastroenterology Health Partners Louisville Kentucky Recruiting
Care Access - New Iberia New Iberia Louisiana Recruiting
Louisiana Research Center Shreveport Louisiana Recruiting
Capital Digestive Care - Chevy Chase Chevy Chase Maryland Recruiting
Lucida Clinical Trials New Bedford Massachusetts Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire Recruiting
Icahn School of Medicine at Mount Sinai New York New York Recruiting
New York Gastroenterology Associates New York New York Recruiting
Care Access - Yonkers Yonkers New York Recruiting
Coastal Research Institute - Fayetteville Fayetteville North Carolina Recruiting
Gastro Intestinal Research Institute of Northern Ohio, LLC Westlake Ohio Recruiting
Thomas Jefferson University - Medicine/GI and Hepatology Philadelphia Pennsylvania Recruiting
University Gastroenterology Providence Rhode Island Recruiting
Gastroenterology Associates - Patewood Greenville South Carolina Recruiting
Gastroenterology Center Of The Midsouth Cordova Tennessee Recruiting
Gastroenterology Research of San Antonio San Antonio Texas Recruiting
Southern Star Research Institute San Antonio Texas Recruiting
Tyler Research Institute Tyler Texas Recruiting
Gastroenterology Consultants of Southwest Virginia Roanoke Virginia Recruiting
Washington Gastroenterology - Tacoma Tacoma Washington Recruiting
Wisconsin Center for Advanced Research Milwaukee Wisconsin Recruiting
Medizinische Universität Graz Graz Austria Recruiting
Medizinische Universitaet Innsbruck Innsbruck Austria Recruiting
Medizinische Universität Wien Vienna Austria Recruiting

+ 147 more sites — see the full list on the official registry below.

On this site

📄 Omvoh (mirikizumab) drug profile → 📄 Mounjaro (tirzepatide) drug profile →

More Eli Lilly and Company trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06937086 on ClinicalTrials.gov ↗ ← All trials in the UK