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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
ID07415044

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating LY4268989 for Moderately to Severely Active Ulcerative Colitis in Adults

Led by Eli Lilly and Company · Updated on 2026-08-06

1431

Participants Needed

258

Research Sites

56 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of LY4268989 compared to a placebo in adults with moderately to severely active ulcerative colitis UC. The study focuses on participants with a diagnosis of UC for at least 3 months, confirmed by specific clinical and endoscopic criteria. This Phase 2 trial aims to better understand how LY4268989 may impact clinical remission and response in this patient group over a long-term period. Participants will receive either one of two doses of LY4268989 or a placebo, all administered orally. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to approximately 108 weeks, excluding the screening phase, allowing for assessment of the drug over an extended time. During the study, participants will undergo regular evaluations including clinical assessments using the Modified Mayo Score to measure remission and response at multiple time points, including weeks 10 and 52. Researchers will also monitor symptomatic response and measure plasma concentrations of LY4268989. Safety and effectiveness will be tracked through these clinical and laboratory tests to understand the drugs impact on UC over the study duration.

CONDITIONS

Brief Title

LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis

Research Team

T

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

P

Physicians interested in becoming principal investigators please contact

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