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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis, Obesity or Overweight

In brief

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.

Key facts

Study ID

NCT06937086

Run by

Eli Lilly and Company

People needed

350

Starts

2025-06-26

Expected to finish

2028-04-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Smart Cures Clinical Research — Anaheim, California, United States (enrolling)
• Cedars-Sinai Medical Center — Beverly Hills, California, United States (enrolling)
• United Medical Doctors - Los Alamitos — Los Alamitos, California, United States (enrolling)
• California Medical Research Associates — Northridge, California, United States (enrolling)
• Research Associates of South Florida - Miami - Southwest 8th Street — Miami, Florida, United States (enrolling)
• Gastro Health Research - Miami — Miami, Florida, United States (enrolling)
• Orlando Health — Orlando, Florida, United States (enrolling)
• Digestive and Liver Center of Florida — Orlando, Florida, United States (enrolling)
• Gastro Health Research - Pensacola — Pensacola, Florida, United States (enrolling)
• Precision Clinical Research — Sunrise, Florida, United States (enrolling)
• Grand Teton Research Group — Idaho Falls, Idaho, United States (enrolling)
• Rush University Medical Center — Chicago, Illinois, United States (enrolling)
• Indiana University Health University Hospital — Indianapolis, Indiana, United States (enrolling)
• Gastroenterology Health Partners — New Albany, Indiana, United States (enrolling)
• Gastroenterology Health Partners — Louisville, Kentucky, United States (enrolling)
• Care Access - New Iberia — New Iberia, Louisiana, United States (enrolling)
• Louisiana Research Center — Shreveport, Louisiana, United States (enrolling)
• Capital Digestive Care - Chevy Chase — Chevy Chase, Maryland, United States (enrolling)
• Lucida Clinical Trials — New Bedford, Massachusetts, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• New York Gastroenterology Associates — New York, New York, United States (enrolling)
• Care Access - Yonkers — Yonkers, New York, United States (enrolling)
• Digestive Health Specialists — Dothan, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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