Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

Conditions

• Crohn's Disease
• Obesity or Overweight

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Mirikizumab — DRUG
  Administered IV
• Mirikizumab — DRUG
  Administered SC
• Tirzepatide — DRUG
  Administered SC
• Placebo — DRUG
  Administered SC

Study Details

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.

Key Dates

Start date

Jun 26, 2025

Status verified

Jun 2026

Primary completion

May 31, 2028

Completion

May 31, 2028

Study Design

Enrollment

290 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Mirikizumab + Tirzepatide
  Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC). Tirzepatide administered SC.
• Experimental: Mirikizumab + Placebo
  Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.

Primary Outcome Measure

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

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (35)

Find similar trials in Dothan, AL

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