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

Korábbi kezelés

• Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening.

Más betegség

• Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis.
• 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 current or recent acute, active infection.

Egyéb

• 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 had more than 5% body weight change in the past 3 months

• 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