LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis

In plain English

What this trial is testing

This study is testing LY4268989 (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate and Ulcerative Colitis, Active Severe.

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 ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC
• Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by central reader and rectal bleeding (RB)≥1
• Have evidence of UC extending proximal to the rectum
• Have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization, if the participant has a history of UC symptoms…
• Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate…
• Must meet contraception requirements

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 1431 participants are expected to take part.
• The study has 3 groups.
• Start date: 2026-03-26.
• Main results expected around 2030-06 (estimate from the record).
• 258 study sites listed (170 marked recruiting) in Argentina, Brazil, Canada, China and Colombia and 23 more countries.

Groups in this study

• LY4268989 Study Dose 1 (listed as: experimental group)
• LY4268989 Study Dose 2 (listed as: experimental group)
• Placebo Study Dose (listed as: placebo group)

Main thing being measured

• Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) (Week 10)
• Percentage of Participants Who Achieve Clinical Remission with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10 (Week 52)

In the researchers’ words

The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally. The study will last up to approximately 108 weeks, excluding screening.

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.