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

NCT06937099

RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Crohn's Disease, Obesity or Overweight

Interventions: Mirikizumab, Mirikizumab, Tirzepatide, Placebo

Countries: United States, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD
* Have obesity body mass index 30 kilograms per meter squared (BMI ≥30 kg/m²), or overweight (BMI ≥27 kg/m2 to \<30 kg/m²) and in the presence of at least 1 weight-related comorbid conditions:

* hypertension
* Type 2 diabetes mellitus (T2DM)
* dyslipidemia
* obstructive sleep apnea, or
* cardiovascular disease.
* Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline.
* Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for patients with ileal-colonic or ≥4 for patients with isolated ileal disease within 21 days before the first dose of study treatment.
* Participants with a history of CD for ≥8 years involving only or predominantly the colon must have documented negative results for colorectal dysplasia and cancer within 1 year prior to baseline.
* Demonstrated inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced CD therapy

Exclusion Criteria:

* Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis.
* Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum.
* Currently have or are suspected to have an abscess.
* Have a stoma, ileoanal pouch, or ostomy.
* Have a history of more than 3 small bowel resections, total resection of small bowel greater than 100 centimeters (cm), diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline.
* Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.
* Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening.
* Have had more than 5% body weight change in the past 3 months
* Have a current or recent acute, active infection.

Locations (184)

Dothan, Alabama, United States
Anaheim, California, United States
Beverly Hills, California, United States
Los Alamitos, California, United States
Northridge, California, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Sunrise, Florida, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
New Albany, Indiana, United States
Louisville, Kentucky, United States
New Iberia, Louisiana, United States
Shreveport, Louisiana, United States
Chevy Chase, Maryland, United States
New Bedford, Massachusetts, United States
St Louis, Missouri, United States
Lebanon, New Hampshire, United States
New York, New York, United States
Yonkers, New York, United States
Fayetteville, North Carolina, United States
Westlake, Ohio, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Greenville, South Carolina, United States
Cordova, Tennessee, United States
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