1431 Participants NeededMy employer runs this trial

LY4268989 for Ulcerative Colitis

(EMERALD-3 Trial)

Recruiting at 265 trial locations
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Overseen ByTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Eli Lilly and Company
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new oral treatment called LY4268989 for individuals with moderately to severely active ulcerative colitis, a condition that causes inflammation in the colon. Participants will receive either the study medication or a placebo, a harmless pill with no active drug. The trial suits those who have had ulcerative colitis for at least three months, experience frequent symptoms, and haven't responded well to standard medications. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, it mentions that participants should have had an inadequate response to or intolerance to at least one conventional medication or advanced therapy, which might imply that some current medications could be continued.

Is there any evidence suggesting that LY4268989 is likely to be safe for humans?

Research has shown that LY4268989 is generally well-tolerated. For example, one study combined LY4268989 with mirikizumab and found it safe for treating ulcerative colitis. Another study found that LY4268989, also known as MORF-057, was well-tolerated by patients with moderate to severe ulcerative colitis, with few serious side effects. No major safety issues emerged, suggesting the treatment is safe for humans.

This treatment is currently in Phase 2 trials, indicating it has passed initial safety tests and is now being studied for efficacy and further safety evaluations.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for ulcerative colitis, which often involve anti-inflammatory drugs like mesalamine or immunosuppressants such as azathioprine, LY4268989 offers a novel approach. Researchers are excited about LY4268989 because it introduces a new active ingredient designed to target specific pathways involved in inflammation, potentially offering more precise control over the condition. This treatment is administered orally, which could improve convenience and adherence compared to treatments that require injection or infusion. The unique mechanism of LY4268989 may offer hope for patients who do not respond well to existing therapies.

What evidence suggests that LY4268989 might be an effective treatment for ulcerative colitis?

Studies have shown that LY4268989, also known as MORF-057, shows promise for treating ulcerative colitis. Early research indicates that patients taking higher doses of this drug achieved better results, such as clinical remission. In this trial, participants will receive either LY4268989 at various study doses or a placebo. The drug was well-tolerated, indicating it is generally safe for patients. While more information is needed, these initial findings suggest LY4268989 could effectively help manage symptoms of ulcerative colitis.13678

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults with moderately to severely active ulcerative colitis diagnosed at least 3 months ago. Participants must have tried and not responded well to at least one standard or advanced UC treatment, and their disease must extend beyond the rectum. Certain colonoscopy requirements apply.

Inclusion Criteria

I have had ulcerative colitis diagnosed for at least 3 months with endoscopic proof.
My ulcerative colitis is moderately to severely active with recent bleeding.
My ulcerative colitis extends beyond the rectum.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY4268989 or placebo orally for the treatment of moderately to severely active ulcerative colitis

104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LY4268989

Trial Overview

The study compares an oral medication called LY4268989 against a placebo (inactive pill) in people with moderate to severe ulcerative colitis. Participants are randomly assigned to either group, and the study lasts up to about two years.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: LY4268989 Study Dose 2Experimental Treatment1 Intervention
Group II: LY4268989 Study Dose 1Experimental Treatment1 Intervention
Group III: Placebo Study DosePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

Study Details | NCT07186101 | LY4268989 (MORF-057 ...

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 ...

Lilly's Omvoh (mirikizumab-mrkz) demonstrated early and ...

Lilly's Omvoh (mirikizumab-mrkz) demonstrated early and sustained improvement in bowel urgency outcomes for patients with ulcerative colitis.

Lilly's Omvoh (mirikizumab-mrkz) is the first and only IL ...

78% achieved corticosteroid-free clinical remission · 78% sustained long-term clinical remission · 81% sustained endoscopic remission, defined as ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40769468/

A Phase 2 Study of MORF-057, an Oral α4β7 Integrin ...

Conclusions: Overall, this study demonstrated that oral MORF-057 is well tolerated, with promising efficacy for individuals with moderately to ...

Patients with Crohn's disease maintained steroid-free ...

Landmark VIVID-2 data showed more than 90% of patients who achieved steroid-free remission at one year maintained steroid-free control ...

LY4268989 (MORF-057) Co-Administered With Mirikizumab ...

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 ...

Eli Lilly Reports Positive Data on Omvoh in Ulcerative ...

Eli Lilly Reports Positive Data on Omvoh in Ulcerative Colitis Patients · Reduced by 52% at Week 28. · Patients reported a 55% reduction in the ...

NCT05291689 | A Phase 2a Open-Label Study to Evaluate ...

This is an open-label, single arm, multicenter, Phase 2a study evaluating the efficacy, safety, and tolerability of MORF-057 in adult patients with Moderately ...