ClinicalTrials.gov
Cure8 trial brief
Why This Matters
The study tests whether adding tirzepatide or a Mediterranean diet to stable anti-TNF therapy is feasible and acceptable for adults with mildly active Crohn's disease who are overweight — a question relevant as GLP-1/GIP medications become more widely used for metabolic indications.
Who Should Pay Attention
Adults with Crohn's disease who are overweight and are on biologic therapy, gastroenterologists managing IBD patients, dietitians, and researchers studying metabolic therapies or diet interventions in IBD.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 4
Enrollment24 participants
Study statusActive_not_recruiting
Source depthTrial registry record
What To Know
This is an interventional Phase 4 study at the University of Miami enrolling adults with Crohn's disease (Harvey Bradshaw Index 5–7) and BMI ≥27 who are on stable anti-TNF therapy. One arm receives tirzepatide injections weekly (dose-escalation over 12 weeks); the other arm receives guided Mediterranean-diet counseling with fiber targets.
Primary measures include retention and adherence metrics over 12 weeks. Key exclusions include diabetes, prior use of GIP/GLP-1 RAs, recent small-bowel obstruction or known strictures, pregnancy, and personal/family history of medullary thyroid cancer or MEN2.
Design and limitations: The trial plans a small enrollment (24 participants) and is described as active but not recruiting. As a Phase 4 interventional study focusing on feasibility/adherence and short-term outcomes (12 weeks), it is not designed to provide definitive efficacy or long-term safety conclusions for tirzepatide in Crohn's disease.
Keep In Mind
This is a single-site Phase 4 trial with planned enrollment of 24 and a 12-week intervention period; it emphasizes adherence and retention rather than long-term clinical outcomes. The record is a trial registry entry (ClinicalTrials.gov) and does not report results.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorUniversity of Miami
Trial IDNCT06774079
Study typeInterventional
Trial phasePhase 4
Enrollment24 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedOct 29, 2026, 12:00 AM
Content availableTrial registry record
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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