COMMIT-CD

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 Crohn’s disease (CD) and obesity, or overweight.

The maximum duration of this study is up to 61 weeks.

In order to participate you must meet the following criteria:

• Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD.
• Are obese, as defined by having a body mass index (BMI) of 30 kilograms per meter squared (BMI ≥30 kg/m²), or are overweight (BMI ≥27 kg/m2 to <30 kg/m²) and are in the presence of at least one of the following weight-related comorbid conditions:
  • Hypertension
  • Type 2 diabetes mellitus (T2DM)
  • Dyslipidemia
  • Obstructive sleep apnea
  • 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.
• Have demonstrated inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced CD therapy.

You will be excluded from the study if any of the following criteria apply to you:

• Have a current diagnosis of ulcerative colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis.
• Have more than two missing segments of the following five segments:
  • Terminal ileum
  • Right colon
  • Transverse colon
  • Left colon
  • 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.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.