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
Eli Lilly and Company
Summary
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.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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: * hypertension * Type 2 diabetes mellitus (T2DM) * dyslipidemia * obstructive sleep apnea, or * cardiovascular disease. * 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…
Interventions
- DrugMirikizumab
Administered IV
- DrugMirikizumab
Administered SC
- DrugTirzepatide
Administered SC
- DrugPlacebo
Administered SC
Locations (187)
- 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