Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study

Conditions

• Obesity or Overweight
• Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Mirikizumab — DRUG
  Administered IV
• Mirikizumab — DRUG
  Administered SC
• Tirzepatide — DRUG
  Administered SC
• Placebo — DRUG
  Administered SC

Study Details

The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight. Participation in this study will last up to 61 weeks, including 52 weeks of treatment.

Key Dates

Start date

Jun 26, 2025

Status verified

Jun 2026

Primary completion

Apr 30, 2028

Completion

Apr 30, 2028

Study Design

Enrollment

350 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Mirikizumab + Tirzepatide
  Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC). Tirzepatide administered SC.
• Experimental: Mirikizumab + Placebo
  Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.

Primary Outcome Measure

Percentage of Participants Who Simultaneously Achieve Clinical Remission and at Least 10% Weight Reduction [ Time Frame: Week 52 ]

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 (37)

Find similar trials in Dothan, AL

Related Studies

• Immune Regulation in Ulcerative Colitis or Crohn s Disease
  Recruiting · National Institute of Allergy and Infectious Diseases (NIAID) · Bethesda, Maryland
• Fecal Microbiome Transplant
  PHASE1 · Enrolling By Invitation · Judith Kelsen · Philadelphia, Pennsylvania
• Improving the Quality of Care for Adults With Inflammatory Bowel Disease
  Enrolling By Invitation · Dartmouth-Hitchcock Medical Center · Los Angeles, California
• The Influence of a Fasting Mimicking Diet on Ulcerative Colitis
  Recruiting · Stanford University · Palo Alto, California