Cure8 trial brief
Combining a UC biologic (mirikizumab) with a weight-loss drug (tirzepatide) could address both intestinal inflammation and excess weight, which may be important for people with moderately to severely active ulcerative colitis who are overweight or have obesity.
Adults with moderately to severely active ulcerative colitis who are overweight or have obesity; clinicians treating IBD; researchers and trialists interested in combination therapy and metabolic effects in IBD.
This is a Phase 3b interventional trial testing whether adding tirzepatide (a GLP-1/GIP agonist for weight loss) to mirikizumab treatment improves both clinical remission of ulcerative colitis and at least 10% body-weight reduction over 52 weeks.
The study enrolls adults with moderately to severely active UC who are overweight or have obesity and have had prior inadequate response or intolerance to conventional or advanced UC therapies. Participants receive IV then SC mirikizumab plus either SC tirzepatide or SC placebo, with planned follow-up to Week 52 and total participation up to 61 weeks.
The registry record lists key inclusion/exclusion criteria (UC confirmed by endoscopy and histology, mMS 5-9, BMI thresholds, exclusions for Crohn's disease, PSC, recent surgery, or insulin-treated diabetes) and primary outcome (simultaneous clinical remission and ≥10% weight reduction at Week 52).
Sites are in the United States and planned enrollment is ~350. This summary is based on the clinicaltrials.gov record provided (trial NCT06937086) and describes the registered study design and eligibility; it does not report trial results.
This is a registered Phase 3 interventional trial record (recruiting). The registry lists planned design, eligibility, interventions, and primary outcome but does not provide results. Tirzepatide is being studied here for weight reduction alongside mirikizumab for UC; safety and efficacy outcomes remain to be determined by the trial.
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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