LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:

In plain English

What this trial is testing

This study is testing LY4268989 (a drug) and Mirikizumab (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.

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 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.

Who can join

• Ages 18 to 80
• Any sex

Some of the main requirements, copied from the record:

• Have had an established diagnosis of UC of ≥3 months in 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 mMS of 5 to 9 with an ES ≥2 confirmed by central reader at screening endoscopy and RB ≥1.
• Participants with greater than 8 years of UC symptoms have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local country or regional medical guidelines, to evaluate for polyps, dysplasia, or…
• Are up-to-date on colorectal cancer surveillance per local society guidelines
• Have an inadequate response to, loss of response to, or intolerance to at least 1 of the medications:
• Conventional-failed participants: Participants who have had an inadequate response to or a loss of response to or are intolerant to at least 1 of the following medications: corticosteroids or immunomodulators (Does not apply to US)

Plus 6 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 252 participants are expected to take part.
• The study has 2 groups.
• Start date: 2025-11-10.
• Main results expected around 2027-05 (estimate from the record).
• 147 study sites listed (134 marked recruiting) in Austria, Brazil, Canada, China and Denmark and 12 more countries.

Groups in this study

• LY4268989 + Mirikizumab (listed as: experimental group)
• Mirikizumab + LY4268989 Placebo (listed as: experimental group)

Main thing being measured

• Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) (Week 12)

In the researchers’ words

The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC). Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.

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.