RecruitingPhase 2interventionalRules rewrite

Phase 2: testing LY4268989 for Ulcerative Colitis (UC)

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

Official registry: https://clinicaltrials.gov/study/NCT07415044 · Eli Lilly and Company · enrollment listed as 1,431

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are LY4268989, or Placebo. The registry lists allocation as randomized. The main purpose of this study is to measure the safety and effectiveness of LY4268989 when compared to dummy treatment (placebo) in adult participants with moderately to severely active ulcerative colitis (UC).

They plan to enroll about 1,431 people at 258 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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)

Interventions: LY4268989, Placebo

Primary outcome (registry wording): Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS)

Who it is for (from inclusion criteria)

Ages 18 Years to 80 Years
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
Must meet contraception requirements

Who the registry excludes

Have a current diagnosis of
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

Public study contact (from the registry)

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

LillyTrials@Lilly.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

258 listed

Valleywise Health Medical Center — Phoenix, Arizona (recruiting)
One of a Kind Clinical Research Center — Scottsdale, Arizona (recruiting)
Clinnova Research — Anaheim, California (recruiting)
GMC Clinical Research — Folsom, California (recruiting)
Om Research LLC — Temple City, California (recruiting)
Om Research LLC — Victorville, California (recruiting)
Peak Gastroenterology Associates — Colorado Springs, Colorado (recruiting)
Advanced Research Institute - Denver — Denver, Colorado (suspended)
Rocky Mountain Gastroenterology Associates - Lakewood — Lakewood, Colorado (recruiting)
Medical Research Center of Connecticut — Hamden, Connecticut (not_yet_recruiting)
K2 Medical Research - Daytona Beach — Daytona Beach, Florida (recruiting)
Clinical Research of Osceola — Kissimmee, Florida (recruiting)

+ 206 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07415044 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07415044?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07415044?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary