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

In plain English

What this trial is testing

This study is testing Mirikizumab (a drug), Mirikizumab (a drug) and Tirzepatide (a drug) as a possible treatment. Condition(s) listed: Crohn's Disease and Obesity or Overweight.

Participants are assigned to groups by chance (randomized).

Some participants receive a placebo or sham for comparison.

It is blinded: participants and the study team do not know who receives what.

Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.

Who can join

• Ages 18 to 70
• Any sex

Some of the main requirements, copied from the record:

• 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

Plus 5 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 290 participants are expected to take part.
• The study has 2 groups.
• Start date: 2025-06-26.
• Main results expected around 2028-05 (estimate from the record).
• 183 study sites listed (172 marked recruiting) in Austria, Belgium, Brazil, Bulgaria and Canada and 17 more countries.

Groups in this study

• Mirikizumab + Tirzepatide (listed as: experimental group)
• Mirikizumab + Placebo (listed as: experimental group)

Main thing being measured

• 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)

In the researchers’ words

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.

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.