NCT06937099

Mirikizumab and Tirzepatide Administered 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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 290 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease
• Obesity or Overweight

Interventions

Type	Name	Description
DRUG	Mirikizumab	Administered IV
DRUG	Mirikizumab	Administered SC
DRUG	Tirzepatide	Administered SC
DRUG	Placebo	Administered SC

Timeline

• Start date: 2025-06-26
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2025-04-22
• Last updated: 2026-04-17

Locations

187 sites across 22 countries: United States, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Puerto Rico, Romania, Slovakia, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study