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NCT07186101 · ClinicalTrials.gov registry record · Phase 2
LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
A Phase 2 study of Ulcerative Colitis, sponsored by Eli Lilly and Company.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 252
- Enrollment target
- 20
- Study locations
NCT07186101: Recruiting Phase 2 study of Ulcerative Colitis, sponsored by Eli Lilly and Company.
NCT07186101 is a Phase 2 study of Ulcerative Colitis that is actively recruiting participants, run by Eli Lilly and Company. The registered enrollment target is 252 participants, below the 2,055-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07186101, a Phase 2 study of Ulcerative Colitis, is actively recruiting participants, sponsored by Eli Lilly and Company.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 252 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The mMS is a composite score reported by participants and physician and is comprised of the following 3 subscores: Stool Frequency (SF); Rectal Bleeding (RB), and Endoscopic Subscore (ES). Clinical remission (mMS) is defined as: * SF subscore = 0 or 1 and no greater than baseline * RB subscore = 0 * Centrally read ES = 0 or 1; score of 1 modified to exclude friability
Conditions Studied
Interventions
- DRUG Mirikizumab
- DRUG LY4268989
- DRUG LY4268989 Placebo
Study Locations (20)
Florida
- NeoClinical Research - Hialeah
- Encore Borland-Groover Clinical Research - Jacksonville
- Clinical Research of Osceola - Kissimmee
- Florida Research Institute - Lakewood Rch
- Alliance Medical Research - Lighthouse PT
- Atlantic Medical Research - Margate
- Digestive and Liver Center of Florida - Orlando
Illinois
- Center for Gastrointestinal Health - Fairview Heights - Belleville
- Midtown Gastroenterology and Liver Disease - Des Plaines
- GI Alliance - Glenview - Glenview
- Gi Alliance - Gurnee - Gurnee
California
- Clinnova Research - Anaheim - Anaheim
- Om Research LLC - Lancaster
- Biopharma Informatic, LLC - Los Angeles
Arizona
- Mayo Clinic in Arizona - Scottsdale - Scottsdale
Colorado
- Peak Gastroenterology Associates - Colorado Springs
Indiana
- Gastroenterology Health Partners - New Albany
Kentucky
- Gastroenterology Health Partners - Louisville
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2025-11-11 |
| Est. Completion | 2029-03 |
| Phase | Phase 2 |
What NCT07186101 shows while recruiting
NCT07186101 is an interventional study that assigns participants to a tested intervention. The registered 252 participants enrollment target is mid-sized for trials with a published cap, below the 2,055-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 3 interventions - of which Mirikizumab is the first listed.
NCT07186101 names 20 study sites across 9 states, led by Florida, Illinois, California.
Frequently Asked Questions
What is clinical trial NCT07186101 about?
NCT07186101 is a clinical study titled "LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:". 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 wee...
What is the current status of trial NCT07186101?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 252 participants. The study started on 2025-11-11. Estimated completion is 2029-03.
What conditions does trial NCT07186101 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT07186101?
The interventions under investigation include: Mirikizumab (DRUG), LY4268989 (DRUG), LY4268989 Placebo (DRUG).
Who is sponsoring clinical trial NCT07186101?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07186101 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07186101's enrollment target sits among peer trials
252 37th of 122 higher than 86 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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