Actively Recruiting
Phase 2 Trial of LY4268989 Combined With Mirikizumab for Adults With Moderate to Severe Ulcerative Colitis
Led by Eli Lilly and Company · Updated on 2026-08-06
252
Participants Needed
147
Research Sites
95 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of LY4268989 combined with mirikizumab compared to mirikizumab alone in adults with moderately to severely active ulcerative colitis. This phase 2 study aims to understand if the combination can better manage the condition. The study is sponsored by Eli Lilly and Company and involves a randomized, double-blind design with parallel groups. Participants receive either LY4268989 orally along with mirikizumab given intravenously and then subcutaneously, or mirikizumab with a placebo pill matching LY4268989. Responders to treatment will be re-randomized for a second study period. Treatment lasts approximately 104 weeks with up to 21 visits planned throughout the study. During the study, participants undergo assessments including clinical remission evaluation using the modified Mayo Score at weeks 12, 24, and 48, endoscopic improvement, and symptomatic remission measurements. Safety and response are closely monitored through scheduled visits. Overall participation lasts about 118 weeks, allowing researchers to gather long-term data on the treatments being studied.
CONDITIONS
Brief Title
LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
Research Team
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Physicians interested in becoming principal investigators please contact
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