Cure8 trial brief
People with Crohn’s disease who are overweight or have obesity may have different disease and treatment needs. This Phase 3 trial is testing whether adding tirzepatide to mirikizumab improves both disease outcomes and weight loss, which could be relevant for patients struggling with both active CD and excess weight.
Adults with moderately to severely active Crohn’s disease who are overweight or have obesity, clinicians treating IBD patients with obesity, researchers studying combination therapies or metabolic-IBD interactions, and patients with perianal fistulizing disease (eligible per protocol).
This trial is testing a combination approach: an IL-23–targeted biologic (mirikizumab) plus tirzepatide (a weight-loss/antidiabetic agent) versus mirikizumab plus placebo in people with Crohn’s disease and overweight/obesity. The primary outcome is a composite of symptom remission, endoscopic healing, and meaningful weight loss at 52 weeks.
If you or your clinician are considering trial participation, note the specific BMI and comorbidity requirements, prior treatment failure criteria, and exclusion for insulin-treated diabetes or recent surgeries.
The study includes endoscopic assessments and centrally read SES-CD scores, so expect colonoscopy and related monitoring during screening and on-study visits. Enrollment centers are in the United States; contact details and full eligibility are on ClinicalTrials.gov.
This is a registered Phase 3 trial record (ClinicalTrials.gov) describing planned study design and eligibility; it does not report results. Participation carries typical clinical-trial requirements (screening colonoscopy, centralized endoscopy reading, safety monitoring).
The trial excludes insulin-treated diabetes and some recent surgical histories, which may limit generalizability.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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