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 Crohn's Disease and Obesity or Overweight
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 Crohn's Disease and Obesity or Overweight
The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight.
The maximum duration of this study is up to 61 weeks.
Inclusion Criteria:
Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD
Have obesity body mass index 30 kilograms per meter squared (BMI ≥30 kg/m²), or overweight (BMI ≥27 kg/m2 to <30 kg/m²) and in the presence of at least 1 weight-related comorbid conditions:
Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline.
Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for patients with ileal-colonic or ≥4 for patients with isolated ileal disease within 21 days before the first dose of study treatment.
Participants with a history of CD for ≥8 years involving only or predominantly the colon must have documented negative results for colorectal dysplasia and cancer within 1 year prior to baseline.
Demonstrated inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced CD therapy
Exclusion Criteria:
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Liège, 4000, Belgium
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Edmonton, T5R 1W2, Canada
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Bologna, 40138, Italy
Castellana Grotte, 70013, Italy
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