Trials / Recruiting
RecruitingNCT06937086
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
A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mirikizumab | Administered IV |
| DRUG | Mirikizumab | Administered SC |
| DRUG | Tirzepatide | Administered SC |
| DRUG | Placebo | Administered SC |
Timeline
- Start date
- 2025-06-26
- Primary completion
- 2028-04-01
- Completion
- 2028-04-01
- First posted
- 2025-04-22
- Last updated
- 2026-04-17
Locations
191 sites across 23 countries: United States, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Puerto Rico, Romania, Slovakia, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06937086. Inclusion in this directory is not an endorsement.