RecruitingUlcerative ColitisObesity or Overweight

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

Eligible age

18–70 yrs

Accepts

All genders

Locations

23 states

Healthy volunteers

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About this study

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.

Sponsor: Eli Lilly and Company

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

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.