NCT07186101 · Eli Lilly and Company
LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
(TOPAZ-UC)
What this study is about
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 114 weeks, including 104 weeks of treatment and may include up to 21 visits.
View original scientific description
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 114 weeks, including 104 weeks of treatment and may include up to 21 visits.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Have had an established diagnosis of ulcerative colitis (UC) of ≥3 months in before baseline, which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC
- Have moderately to severely active UC as 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, with endoscopy performed within 14 days before baseline
- Participants with greater than 8 years of UC symptoms have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local country or regional medical guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization
- Are up-to-date on colorectal cancer surveillance per local society guidelines
- Have an inadequate response to, loss of response to, or intolerance to at least 1 of the medications:
- Conventional-failed participants: Participants who have had an inadequate response to
Where
- Scottsdale, Arizona
- Anaheim, California
- Lancaster, California
- Los Angeles, California
- Colorado Springs, Colorado
- Hialeah, Florida
- Jacksonville, Florida
- Kissimmee, Florida
- Lakewood Rch, Florida
- Lighthouse PT, Florida
- Margate, Florida
- Orlando, Florida
And 28 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations