Recruiting
Phase 2

MORF-057

Sponsor:

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

Code:

NCT06226883

Conditions

Inflammatory Bowel Diseases

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Placebo

MORF-057

Study Details

Brief summary:

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).

Conditions

Inflammatory Bowel Diseases

Crohn's Disease

Study ID

NCT06226883

Start date

Jul 18, 2024

Status verified date

Sep, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Has signs/symptoms of CD for at least 90 days prior to screening
  • Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and/or an average daily abdominal pain subscore of ≥2 points
  • Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)
  • Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants (eg, azathioprine, 6-mercaptopurine, methotrexate) and/or advanced therapies for CD (eg, biologic agents, Janus kinase \[JAK\] inhibitors, applicable investigational products)

Key Exclusion Criteria:

  • Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC
  • Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement
  • Has had extensive bowel resection (>100 cm), and/or more than 3 resections, and/or has a known diagnosis of short bowel syndrome
  • Is currently receiving total parenteral nutrition, tube feeding, or a formula diet
  • Has positive findings on a subjective neurological screening questionnaire
  • Has a concurrent, clinically significant, serious, unstable comorbidity
  • Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors
  • Is currently participating in any other interventional study or has 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
  • Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease

Study Design

Enrollment

385 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1 (Part A)

Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period

experimental: Group 2 (Part A)

Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period

placebo comparator: Group 3 (Part A)

Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period

experimental: Group 4 (Part B)

Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period

experimental: Group 5 (Part B)

Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period

placebo comparator: Group 6 (Part B)

Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period

Interventions

Placebo

Matching placebo (identical appearance to MORF-057) administered orally.

MORF-057

MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.

Primary outcome measure

  • Proportion of participants with endoscopic response at Week 14 as determined using the Simple Endoscopic Score-CD (SES-CD) [ Time Frame: Baseline to Week 14 ]

Central Contacts and Locations

Central contacts

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

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Gastro Care Institute

Recruiting

Lancaster, California, United States, 93534

Contacts

661-529-7550

Principal Investigator:

Kumaravel Perumalsamy

Peak Gastroenterology Associates - Colorado Springs

Recruiting

Colorado Springs, Colorado, United States, 80921

Contacts

719-362-2266

Principal Investigator:

Prashant Krishnan

Clinical Research of Osceola

Recruiting

Kissimmee, Florida, United States, 34741

Contacts

407-846-6331

Principal Investigator:

Basher Atiquzzaman

Bioresearch Partner-Kendale Lakes

Recruiting

Miami, Florida, United States, 33155

Contacts

833-489-4968

Principal Investigator:

Keila Hoover

Endoscopic Research Inc

Recruiting

Orlando, Florida, United States, 32803

Contacts

407-241-1726

Principal Investigator:

Marlon Ilagan

Tropical Clinical Trials

Recruiting

Palmetto Bay, Florida, United States, 33176

Contacts

754-946-4172

Principal Investigator:

MIchael Feldman

Atlanta Gastroenterology Specialists, PC

Recruiting

Atlanta, Georgia, United States, 30024

Principal Investigator:

Steven Thalvinder (Thali) Sangha

Atlanta Gastroenterology Associates (Part of United Digestive)

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

404-257-9000

Principal Investigator:

Nitin Gupta

Tandem Clinical Research

Recruiting

Houma, Louisiana, United States, 70360

Principal Investigator:

Conar Fitton

Cross Creek Medical Clinic

Recruiting

Fayetteville, North Carolina, United States, 28304

Contacts

920-437-5130

Principal Investigator:

Nitinchandra Desai

Peters Medical Research

Recruiting

High Point, North Carolina, United States, 27260

Contacts

336-883-9773

Principal Investigator:

Roy Peters

Palmetto Gastroenterology Clinical Research

Recruiting

Summerville, South Carolina, United States, 29486

Contacts

843-376-0670

Principal Investigator:

Brett Van Leer-Greenberg

Gastrointestinal Associates of Northeast Tennessee

Recruiting

Johnson City, Tennessee, United States, 44060

Contacts

423-208-9073

Principal Investigator:

Chakradhar Reddy

GI Alliance - Cedar Park

Recruiting

Cedar Park, Texas, United States, 78613

Principal Investigator:

Junaid Siddiqui

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Tugrul Purnak

Prime Clinical Research - Lewisville

Recruiting

Lewisville, Texas, United States, 75067

Contacts

817-907-7330

Principal Investigator:

Ayodele Osowo

Prime Clinical Research

Recruiting

Mansfield, Texas, United States, 76063

Principal Investigator:

Olufemi Abiodun

Tyler Research Institute, LLC

Recruiting

Tyler, Texas, United States, 75701

Contacts

903-630-6211

Principal Investigator:

George DuVall

Care Access Research - Ogden

Recruiting

Ogden, Utah, United States, 84403

Principal Investigator:

Chad Gonzales

Gastroenterology Associates of Central Virginia

Recruiting

Lynchburg, Virginia, United States, 24502

Principal Investigator:

Larry Clark, Jr.

Nova Scotia Health Authority

Recruiting

Halifax, Canada, B3H 1V7

Contacts

+902 (473) 1499

Principal Investigator:

Jennifer Jones

London Health Sciences Centre

Recruiting

London, Canada, N6A 4L6

Principal Investigator:

Terry Ponich

Diex Recherche Quebec Inc.

Recruiting

Québec, Canada, G1V 4T3

Principal Investigator:

Pascale Chouinard

Scarborough Center for Inflammatory Bowel Disease

Recruiting

Scarborough, Canada, M1B 3V4

Principal Investigator:

Jason Reinglas

Mount Sinai Hospital

Recruiting

Toronto, Canada, M5G 1X5

Principal Investigator:

Hillary Steinhart

St Joseph'S Health Centre Toronto

Recruiting

Toronto, Canada, M6R 1B5

Principal Investigator:

Ian Bookman

Toronto Digestive Disease Associates, Inc.

Recruiting

Vaughan, Canada, L4L 4Y7

Principal Investigator:

David Ford

More Information

Sponsor

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

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Crohn's disease (CD)
  • Inflammatory bowel disease (IBD)
  • a4b7
  • Moderate-to-severe
  • Integrin
  • GARNET

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) on 2026-09-04.