What is the Purpose of this Study?
The purpose of this study is to evaluate a drug called mirikizumab when taken with another drug, tirzepatide, for the treatment of ulcerative colitis in patients with excess weight or obesity. Mirikizumab may have anti-inflammatory effects on the lining of the inflamed colon or large intestine, and weight reduction from tirzepatide may improve response to mirikizumab. Tirzepatide may also have an anti-inflammatory effect on the gut. The study aims to evaluate whether the combination of mirikizumab and tirzepatide is better than mirikizumab alone. Researchers also want to learn whether mirikizumab and tirzepatide help people lose weight and the possible side effects of the drugs. Study procedures include lab draws, colonoscopies, biopsies, completion of questionnaire and diary, infusions, and self-injections of study medication.
Eligibility
- * 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, \[body mass index (BMI) 30 kilograms per meter squared (kg/m2)\]
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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.
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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered with Tirzepatide in Adult Participants with Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight