Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

NCT06937099 · Recruiting

Last updated 2026-05-28

This clinical trial is testing whether the combination of two medications, mirikizumab and tirzepatide, can help adults with moderately to severely active Crohn's disease and obesity or overweight achieve both disease remission and significant weight loss.

Status Recruiting Currently enrolling participants.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 290 people Planned (estimated).

Who can join Ages 18–70 · all sexes

Timeline Started 2025-06 · est. completion 2028-05

Where 187 sites · Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Puerto Rico, Romania, Slovakia, Spain, Turkey (Türkiye), United States

What this study is testing ClinicalTrials.gov NCT06937099 ↗

Description as written by the study sponsor.

The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight. The maximum duration of this study is up to 61 weeks.

Treatments tested

Mirikizumab also known as LY3074828 Drug

Administered IV
Mirikizumab also known as LY3074828 Drug

Administered SC
Tirzepatide also known as LY3298176 Drug

Administered SC
Placebo Drug

Administered SC

Main thing measured	Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction
Sponsor	Eli Lilly and Company
Conditions studied	Crohn's Disease, Obesity or Overweight
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06937099 ↗