Recruiting

Phase 2

LY4268989 & MirikizumabLY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:

Sponsor:

Eli Lilly and Company

Code:

NCT07186101

Conditions

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LY4268989

Mirikizumab

LY4268989 Placebo

Study Details

Brief summary:

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 participants with moderately to severely active ulcerative colitis (UC).

Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.

Conditions

Ulcerative Colitis

Study ID

NCT07186101

Start date

Nov 10, 2025

Status verified date

Sep, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Have had an established diagnosis of UC of ≥3 months in before baseline, which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC
Have moderately to severely active UC as defined by a mMS of 5 to 9 with an ES ≥2 confirmed by central reader at screening endoscopy and RB ≥1.
Participants with greater than 8 years of UC symptoms have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local country or regional medical guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization
Are up-to-date on colorectal cancer surveillance per local society guidelines
Have an inadequate response to, loss of response to, or intolerance to at least 1 of the medications:
Conventional-failed participants: Participants who have had an inadequate response to or a loss of response to or are intolerant to at least 1 of the following medications: corticosteroids or immunomodulators (Does not apply to US)

NOTE: After the interim analysis, participants with inadequate response, loss of response, or intolerance to conventional UC therapy without prior exposure to biologics may be enrolled if deemed appropriate (Applies to the US)

Advanced therapy-failed participants: Participants who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as:

a biologic or biosimilar medication such as anti-tumor necrosis factor (anti-TNF) antibodies or anti-interleukin antibodies (IL-12/23, or IL-23p19), except for

mirikizumab.
Janus kinase inhibitors (JAK) such as filgotinib, tofacitinib, or upadacitinib
sphingosine 1-phosphate receptor 1 inhibitors (S1PR) such as etrasimod or ozanimod

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 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 adenomatous polyp occurring in areas of the colon not involved by colitis, that has not been removed

Note: If such an adenomatous polyp has been completely removed and shows only low-grade dysplasia, this criterion would no longer apply

Have a current or recent acute, active infection

Study Design

Enrollment

252 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LY4268989 + Mirikizumab

LY4268989 administered orally (PO) + Mirikizumab administered intravenously (IV), then subcutaneously (SC). Responders will be re-randomized for Study Period 2.

experimental: Mirikizumab + LY4268989 Placebo

Mirikizumab administered IV, then SC + LY4268989 placebo administered PO. Responders and Non-responders will re-randomized for Study Period 2.

Interventions

LY4268989

Administered PO

Mirikizumab

Administered IV then SC

LY4268989 Placebo

Administered PO

Primary outcome measure

Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

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

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

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Mayo Clinic in Arizona - Scottsdale

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

480-301-8000

Principal Investigator:

Manreet Kaur

Clinnova Research - Anaheim

Recruiting

Anaheim, California, United States, 92805

Principal Investigator:

Amit Bhanvadia

Om Research LLC

Recruiting

Lancaster, California, United States, 93534

Contacts

661-388-2239

Principal Investigator:

Jatinder Pruthi

Biopharma Informatic, LLC

Recruiting

Los Angeles, California, United States, 90035

Contacts

281-944-3610

Principal Investigator:

Morris Silver, MD

Peak Gastroenterology Associates

Recruiting

Colorado Springs, Colorado, United States, 80907

Contacts

719-310-6719

Principal Investigator:

Bhaktasharan Patel

NeoClinical Research

Recruiting

Hialeah, Florida, United States, 33016

Contacts

305-456-9062

Principal Investigator:

Isaac Bassan

Encore Borland-Groover Clinical Research

Recruiting

Jacksonville, Florida, United States, 32256

Contacts

904-680-0871

Principal Investigator:

Kyle Etzkorn

Clinical Research of Osceola

Recruiting

Kissimmee, Florida, United States, 34741

Contacts

407-954-4016

Principal Investigator:

Basher Atiquzzaman

Florida Research Institute

Recruiting

Lakewood Rch, Florida, United States, 34211

Contacts

941-727-7772

Principal Investigator:

Manuel Rodriguez

Alliance Medical Research

Recruiting

Lighthouse PT, Florida, United States, 33064

Contacts

954-428-2480

Principal Investigator:

Vipin Gupta

Atlantic Medical Research

Recruiting

Margate, Florida, United States, 33063

Contacts

954-850-0589

Principal Investigator:

Peter Gach

Digestive and Liver Center of Florida

Recruiting

Orlando, Florida, United States, 32825

Contacts

407-384-7388

Principal Investigator:

Harinath Sheela

Midtown Gastroenterology and Liver Disease

Recruiting

Des Plaines, Illinois, United States, 60016

Contacts

262-925-1280

Principal Investigator:

John Agaiby

GI Alliance - Glenview

Recruiting

Glenview, Illinois, United States, 60026

Principal Investigator:

Nina Merel

Gi Alliance - Gurnee

Recruiting

Gurnee, Illinois, United States, 60031

Principal Investigator:

Jonathan A. Rosenberg

Gastroenterology Health Partners

Recruiting

New Albany, Indiana, United States, 47150

Contacts

812-206-1702

Principal Investigator:

Robert Luckett

Gastroenterology Health Partners

Recruiting

Louisville, Kentucky, United States, 40218

Contacts

502-888-1988

Principal Investigator:

Michael Krease

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

617-732-6389

Principal Investigator:

Jessica Allegretti

Clinical Research Institute of Michigan, LLC

Recruiting

Clinton Township, Michigan, United States, 48038

Contacts

586-598-3329

Principal Investigator:

Mohanad Suede

GI Associates - GIA and Endoscopy Center - Flowood

Recruiting

Flowood, Mississippi, United States, 39232

Contacts

601-863-0395

Principal Investigator:

Ralph Vance

Digestive Disease Medicine of Central New York

Recruiting

Utica, New York, United States, 13502

Principal Investigator:

Harvey Allen

Dayton Gastroenterology, LLC

Recruiting

Dayton, Ohio, United States, 45415

Contacts

937-320-5050

Principal Investigator:

Drew Triplett

University Gastroenterology - Providence - West River Street

Recruiting

Providence, Rhode Island, United States, 02904

Contacts

401-227-8393

Principal Investigator:

Jason Ferreira

Gastroenterology Associates, P.A. of Greenville

Recruiting

Greenville, South Carolina, United States, 29607

Contacts

864-451-5026

Principal Investigator:

Matthew Barnes

Gastro One - Walnut Run Road

Recruiting

Cordova, Tennessee, United States, 38018

Principal Investigator:

Ziad Younes

Texas Digestive Disease Consultants - Cedar Park

Recruiting

Cedar Park, Texas, United States, 78613

Contacts

512-341-0900

Principal Investigator:

Junaid Siddiqui

GI Alliance - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

817-612-5575

Principal Investigator:

Kumar Gutta

GI Alliance - Garland

Recruiting

Garland, Texas, United States, 75044

Contacts

972-265-8201

Principal Investigator:

Harry Sarles

GI Alliance - Lubbock

Recruiting

Lubbock, Texas, United States, 79410

Contacts

806-793-3141

Principal Investigator:

Adam Hughston

Southern Star Research Institute

Recruiting

San Antonio, Texas, United States, 78229

Contacts

210-581-2812

Principal Investigator:

Jeff Bullock

Tyler Research Institute

Recruiting

Tyler, Texas, United States, 75701

Contacts

903-630-6211

Principal Investigator:

George DuVall

GI Alliance-Webster

Recruiting

Webster, Texas, United States, 77598

Contacts

281-626-7035

Principal Investigator:

Ravi Mani

Care Access - Ogden

Recruiting

Ogden, Utah, United States, 84403

Contacts

801-614-0010

Principal Investigator:

Chad Gonzales

Clinical Research Partners, LLC

Recruiting

Richmond, Virginia, United States, 23226

Principal Investigator:

Kara Foster-Weiss

GI Alliance - Richmond

Recruiting

Richmond, Virginia, United States, 23229

Contacts

804-362-0954

Principal Investigator:

Omer Khalid

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24014

Principal Investigator:

Lana Wahid

Washington Gastroenterology - Bellevue

Recruiting

Bellevue, Washington, United States, 98004

Contacts

425-454-4768

Principal Investigator:

Nicholas Procaccini

Charlton Digestive Disease Centre

Recruiting

Hamilton, Canada, L8N 1Y2

Contacts

905-526-7002 x 3123

Principal Investigator:

Neeraj Narula

London Digestive Disease Institute

Recruiting

London, Canada, N6K 1M6

Principal Investigator:

Vipul Jairath

West GTA Research Inc.

Recruiting

Mississauga, Canada, L5M 2S4

Principal Investigator:

Arif Yusuf

C.I.C. Mauricie inc.

Recruiting

Trois-Rivières, Canada, G8T 7A1

Principal Investigator:

Madeleine Bonneviot

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-08.