Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study

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: Ulcerative Colitis 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 had an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC.
• Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and endoscopic subscore (ES) of 2 to 3 (confirmed by central review) within 21 days before baseline.
• Participants with a history of UC for greater than or equal to 8 years who have had a surveillance colonoscopy completed within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.
• Have obesity, \[body mass index (BMI) 30 kilograms per meter squared (kg/m2)\]
• Have overweight (BMI ≥27 kg/m2 to <30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions:
• hypertension

Plus 5 more requirement(s). There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 350 participants are expected to take part.
• The study has 2 groups.
• Start date: 2025-06-26.
• Main results expected around 2028-04 (estimate from the record).
• 187 study sites listed (177 marked recruiting) in Austria, Belgium, Brazil, Bulgaria and Canada and 18 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 and at Least 10% Weight Reduction (Week 52)

In the researchers’ words

The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight. Participation in this study will last up to 61 weeks, including 52 weeks of treatment.

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.