LY4268989 (MORF-057) Co-Administered with Mirikizumab in Adults with Moderately to Severely Active Ulcerative Colitis: A Phase 2 Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Eli Lilly & Co.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

31 Mar 2026 → ongoing

Decision date (initial)

2026-03-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-522338-30-00

WHO UTN

U1111-1329-2578

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacogenetic, Pharmacodynamic, Pharmacokinetic, Efficacy

To evaluate the 12-week induction efficacy of LY4268989/mirikizumab co-administration compared with mirikizumab monotherapy in participants with moderately-to-severely active UC

Conditions and MedDRA coding

Ulcerative Colitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Have had an established diagnosis of UC of ≥3 months in before baseline
2. Have moderately to severely active UC
3. Have evidence of UC extending proximal to the rectum
4. 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.
5. Are up-to-date on colorectal cancer surveillance
6. Have an inadequate response to, loss of response to, or intolerance to Conventional therapy, Immunomodulators, Advanced therapy

Exclusion criteria 5

1. Have a current diagnosis of Crohn’s disease, IBD unclassified or primary sclerosing cholangitis
2. Have an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation.
3. Have had or will need bowel resection or intestinal or intra-abdominal surgery
4. Are likely to require surgery for the treatment of UC during the study
5. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The proportion of participants who achieve clinical remission with mMS at Week 12

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

Sponsor organisation

Eli Lilly & Co.

Address

1 Lilly Corporate Center

City

Indianapolis

Postcode

46285-0001

Country

United States

Scientific contact point

Organisation

Eli Lilly & Co.

Contact name

Lilly Clinical Trials information desk

Public contact point

Organisation

Eli Lilly & Co.

Contact name

Lilly Clinical Trials information desk

Third parties 17

Locations

9 EU/EEA countries · 42 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 116 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications