NCT07186101

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

A Phase 2, Multicenter, Randomized, Double-Blind, Active-Controlled Study of LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	LY4268989	Administered PO
DRUG	Mirikizumab	Administered IV then SC
DRUG	LY4268989 Placebo	Administered PO

Timeline

• Start date: 2025-11-10
• Primary completion: 2027-05-01
• Completion: 2029-03-01
• First posted: 2025-09-22
• Last updated: 2026-04-17

Locations

149 sites across 17 countries: United States, Austria, Brazil, Canada, China, Denmark, Germany, Hungary, India, Italy, Japan, Mexico, Netherlands, Poland, Romania, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study