Study S000392

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

ClinicalTrials.gov record

Registration

Registration: NCT06937099
Acronym: COMMIT-CD
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: RECRUITING
Enrollment: 290
Start: 2025-06-26
Primary completion: 2028-05
Lead sponsor: Eli Lilly and Company
Conditions: Crohn's Disease; Obesity or Overweight
Interventions: DRUG:Mirikizumab; DRUG:Tirzepatide; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: CTIS:2024-520210-21-00; OTHER:I6T-MC-AMCE

Registered primary outcomes

Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction [Week 52]

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