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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEli Lilly and Company

About this trial

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 criteria

Qualifiers

Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD

hypertension

Type 2 diabetes mellitus (T2DM)

dyslipidemia

Disqualifiers

Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis.

Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum.

Currently have or are suspected to have an abscess.

Have a stoma, ileoanal pouch, or ostomy.

Trial design

Treatments tested in this trial

  • Mirikizumab
  • Mirikizumab
  • Tirzepatide
  • Placebo

Treatment groups

290 Participants
are divided into 2 treatment groups

Sponsors and collaborators