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

Conditions

• Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• LY4268989 — DRUG
  Administered PO
• Mirikizumab — DRUG
  Administered IV then SC
• LY4268989 Placebo — DRUG
  Administered PO

Study Details

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.

Key Dates

Start date

Nov 10, 2025

Status verified

Jun 2026

Primary completion

May 31, 2027

Completion

Mar 31, 2029

Study Design

Enrollment

252 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (41)

Find similar trials in Scottsdale, AZ

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