What is the Purpose of this Study?
The purpose of this study is to learn more about the drug mirikizumab taken in parallel with tirzepatide for the treatment of Crohn’s Disease in patients with excess weight or obesity. Biologic drugs like mirikizumab have anti-inflammatory effects on the lining of the inflamed colon or large intestine. Weight reduction from tirzepatide may improve response to mirikizumab, and tirzepatide may have anti-inflammatory effect on the gut. The study will evaluate whether the combination of mirikizumab and tirzepatide is better than mirikizumab alone. Researchers also want to learn whether the combination of mirikizumab and tirzepatide helps people lose weight, as well as evaluate possible side effects. Participants will be randomly assigned to receive either mirikizumab with tirzepatide, or mirikizumab with placebo (inactive substance). Mirikizumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderately to severely active Crohn’s disease in adults. Tirzepatide is approved by the FDA as an adjunct to a reduced-calorie diet and increased activity for chronic weight management in adults with obesity, or overweight in the presence of at least 1 weight-related coexisting condition. The combination of mirikizumab and tirzepatide is experimental.
Eligibility
- * 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:
- * hypertension
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 Crohn's Disease and Obesity or Overweight