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
Eli Lilly and Company
Summary
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
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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 colorect…
Interventions
- DrugMirikizumab
Administered IV
- DrugMirikizumab
Administered SC
- DrugTirzepatide
Administered SC
- DrugPlacebo
Administered SC
Locations (191)
- Digestive Health SpecialistsDothan, Alabama
- Smart Cures Clinical ResearchAnaheim, California
- Cedars-Sinai Medical CenterBeverly Hills, California
- United Medical Doctors - Los AlamitosLos Alamitos, California
- California Medical Research AssociatesNorthridge, California
- Research Associates of South Florida - Miami - Southwest 8th StreetMiami, Florida