A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC (EMERALD-1)

February 18, 2026 updated by: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)

A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Tolerability of MORF-057 in Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-1)

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 to Severely Active Ulcerative Colitis (UC)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main part of this Phase 2a study will consist of 3 study periods: a Screening Period, a Treatment Period and a Safety Follow-up Period. All participants who complete the open-label Treatment Period will have the opportunity to continue their treatment in an optional 26-week Long-term Extension study after completing the Week 52 assessments.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bydgoszcz, Poland, 85-794
        • Clinical Study Site
      • Elblag, Poland, 82-300
        • Clinical Study Site
      • Katowice, Poland, 40-748
        • Clinical Study Site
      • Lodz, Poland, 90-349
        • Clinical Study Site
      • Lodz, Poland, 90-752
        • Clinical Study Site
      • Oświęcim, Poland, 32-600
        • Clinical Study Site
      • Sopot, Poland, 81-756
        • Clinical Study Site
      • Sosnowiec, Poland, 41-209
        • Clinical Study Site
      • Staszów, Poland, 28-200
        • Clinical Study Site
      • Tychy, Poland, 43-100
        • Clinical Study Site
      • Warsaw, Poland, 00-728
        • Clinical Study Site
      • Warsaw, Poland, 02-665
        • Clinical Study Site
  • United States
    • Florida
      • Tampa, Florida, United States, 33609
        • Clinical Study Site
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Clinical Study Site
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • Clinical Study Site
    • New York
      • Brooklyn, New York, United States, 11235
        • Clinical Study Site
      • New York, New York, United States, 10075
        • Clinical Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has signs/symptoms of moderately to severely active UC for at least 3 months prior to Screening
  • Has evidence of UC extending at least 15 cm from the anal verge
  • Is bio-naïve or had an inadequate response, loss of response, or intolerance to other UC drugs
  • Agrees to abide by the study guidelines and requirements
  • Capable of giving signed informed consent

Exclusion Criteria:

  • Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or Crohn's disease or has clinical findings suggestive of Crohn's disease
  • Has positive findings on a subjective neurological screening questionnaire
  • Has a concurrent, clinically significant, serious, unstable comorbidity
  • Primary non-responder to vedolizumab or other integrin inhibitors
  • Participation in any other interventional study or received any investigational therapy within 30 days
  • Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057
  • Unable to attend study visits or comply with study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MORF-057
Participants received MORF-057 100 milligrams (mg) orally twice daily for up to 78 weeks.
Drug: MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Other Names:
  • LY4268989

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main Cohort: Change From Baseline to Week 12 in the Robarts Histopathology Index (RHI) Score
Time Frame: From baseline to 12 weeks
Robarts Histopathology Index (RHI) Score: the total RHI Score ranges from 0 (no disease activity) to 33 (severe disease activity)
From baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main Cohort: Change From Baseline to Week 12 in the Modified Mayo Clinic Score
Time Frame: From baseline to 12 weeks

The Modified Mayo Clinic Score (mMCS) is a composite of the following Mayo Clinic Score subscores: Endoscopy subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration), Stool Frequency subscore (range: 0=Normal number of stools for this participant to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed).

The total mMCS ranges from 0 to 9, with higher scores indicating more severe disease.
From baseline to 12 weeks
Main Cohort: Maximum Plasma Concentration (Cmax) During Multiple Doses of MORF-057
Time Frame: 12 weeks
To determine the Maximum Plasma Concentration of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose.
12 weeks
Main Cohort: Time to Reach Cmax (Tmax) During Multiple Doses of MORF-057
Time Frame: 12 weeks
To determine the Tmax of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose.
12 weeks
Main Cohort: Area Under the Curve (AUC) Following Multiple Doses of MORF-057
Time Frame: 12 weeks
To determine the area under the concentration-time curve of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2022

Primary Completion (Actual)

October 18, 2023

Study Completion (Actual)

February 19, 2025

Study Registration Dates

First Submitted

March 10, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (Actual)

March 23, 2022

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27506
  • MORF-057-201 (Other Identifier: Morphic Therapeutic, Inc)
  • J6E-MC-KWAL (Other Identifier: Eli Lilly and Company)
  • 2024-516960-27-00 (Ctis)
  • 2021-005288-31 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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