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Clinical Trials/NCT07415044
NCT07415044
Recruiting
Phase 2

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Development Program to Evaluate the Efficacy and Safety of LY4268989 (MORF-057) for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-3)

Eli Lilly and Company454 sites in 5 countries1,431 target enrollmentStarted: March 26, 2026Last updated:
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InterventionsLY4268989Placebo

Overview

Phase
Phase 2
Status
Recruiting
Enrollment
1,431
Locations
454
Primary Endpoint
Percentage of Participants Who Achieve Clinical Remission with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally.

The study will last up to approximately 108 weeks, excluding screening.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Masking Description

Non-responders at week 10 will receive Open Label LY4268989 in maintenance study

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC
  • •Have moderately to severely active UC 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
  • •Have evidence of UC extending proximal to the rectum
  • •Have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization, if the participant has a history of UC symptoms for more than 8 years
  • •Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators). Participants with inadequate response to vedolizumab are excluded
  • •Must meet contraception requirements

Exclusion Criteria

  • •Have a current diagnosis of
  • •Crohn's disease
  • •Inflammatory Bowel Disease (IBD unclassified) (formerly known as indeterminate colitis), or
  • •primary sclerosing cholangitis
  • •Have an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation
  • •Have had or will need bowel resection or intestinal or intra-abdominal surgery
  • •Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic
  • •Have any prior or current evidence of cancer gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancies
  • •Have a diagnosis or history of malignant disease within 5 years prior to randomization

Arms & Interventions

LY4268989 Study Dose 1

Experimental

LY4268989 administered orally

Intervention: LY4268989 (Drug)

LY4268989 Study Dose 2

Experimental

LY4268989 administered orally

Intervention: LY4268989 (Drug)

Placebo Study Dose

Placebo Comparator

Placebo administered orally

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Percentage of Participants Who Achieve Clinical Remission with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10

Time Frame: Week 52

Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS)

Time Frame: Week 10

Secondary Outcomes

  • Percentage of Participants Who Achieve Symptomatic Response Among Participants Who Achieved Clinical Response with LY4268989 at Week 10(Week 10 Up to Week 52)
  • Pharmacokinetics (PK): Plasma Concentrations of LY4268989(Baseline Up to Approximately Week 52)
  • Percentage of Participants Who Achieve Clinical Remission Among Participants Who Achieved Clinical Remission with LY4268989 at Week 10(Week 52)
  • Percentage of Participants Who Achieve Clinical Response with mMS(Week 10)
  • Percentage of Participants Who Achieve Clinical Response with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10(Week 10 Up to Week 52)
  • Percentage of Participants Who Achieve Symptomatic Response(Baseline Up to Week 8)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (454)

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