Mirikizumab given at the same time as tirzepatide for adults with moderate-to-severe ulcerative colitis who are overweight or have obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3b trial compares treatment with mirikizumab plus tirzepatide to mirikizumab plus placebo in adults with moderately to severely active ulcerative colitis and overweight or obesity. Eligible participants have documented UC for at least 3 months, a modified Mayo score of 5–9 with endoscopic subscore 2–3, and meet body mass index criteria (BMI ≥30, or BMI ≥27 with a weight-related comorbidity). Participants are assigned to receive concurrent mirikizumab and either tirzepatide or placebo, with treatment lasting 52 weeks and total participation up to 61 weeks. Endoscopic confirmation is centrally reviewed and the co-primary outcomes include reduction or disappearance of UC symptoms and achieving at least 10% overall body weight loss.

Why it matters

Who can join: the full rules

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.

Where it's running

• Digestive Health Specialists
  Dothan, Alabama, United States Recruiting
• Smart Cures Clinical Research
  Anaheim, California, United States Recruiting
• Cedars-Sinai Medical Center
  Beverly Hills, California, United States Recruiting
• United Medical Doctors - Los Alamitos
  Los Alamitos, California, United States Recruiting
• California Medical Research Associates
  Northridge, California, United States Recruiting
• Research Associates of South Florida - Miami - Southwest 8th Street
  Miami, Florida, United States Recruiting

+136 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• LY4268989 (MORF-057) with mirikizumab for adults with moderate-to-severe ulcerative colitis

  We will test whether adding LY4268989 to mirikizumab helps adults with moderate-to-severe ulcerative colitis get better control than mirikizumab alone.

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• Mirikizumab with or without tirzepatide for adults with moderately to severely active Crohn's disease who are overweight or have obesity

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  Recruiting at 174 sites Phase 3 Eli Lilly and Company · Dothan, Alabama and 182 other locations · NCT06937099

• Evaluating Mirikizumab for Children with Ulcerative Colitis or Crohn's Disease

  This study is testing if a medication called mirikizumab can help children with ulcerative colitis or Crohn's disease feel better over a long period of time.

  Recruiting at 39 sites Phase 3 Eli Lilly and Company · San Francisco, California and 68 other locations · NCT04844606

• Innovative Multidisciplinary and Virtual Care for IBD in Pregnancy

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• Petrelintide for weight management in adults with overweight or obesity

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• Petrelintide for weight management in adults with overweight/obesity and type 2 diabetes

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.