LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis

Conditions

• Ulcerative Colitis (UC)
• Ulcerative Colitis, Active Moderate
• Ulcerative Colitis, Active Severe

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• LY4268989 — DRUG
  Administered orally
• Placebo — DRUG
  Administered orally

Study Details

The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally. The study will last up to approximately 108 weeks, excluding screening.

Key Dates

Start date

Mar 26, 2026

Status verified

Jun 2026

Primary completion

Jun 30, 2030

Completion

Jul 31, 2031

Study Design

Enrollment

1,431 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: LY4268989 Study Dose 1
  LY4268989 administered orally
• Experimental: LY4268989 Study Dose 2
  LY4268989 administered orally
• Placebo Comparator: Placebo Study Dose
  Placebo administered orally

Primary Outcome Measure

Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) [ Time Frame: Week 10 ]

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 (49)

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