About this trial
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 criteria
Qualifiers
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)]
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Mirikizumab
- Mirikizumab
- Tirzepatide
- Placebo
Treatment groups
Locations
189Sponsors and collaborators
Eli Lilly and Company
Lead sponsor