A Randomized Clinical Trial to Determine the Effect of Dual Glucose-dependent Insulinotropic Polypeptide (GIP)/GLP-1 Receptor Agonist-mediated Weight Loss and Diet on Crohn's Disease Clinical Response: a Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The purpose of this study is to use diet and an injectable medication called tirzepatide (Zepbound) glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist (GIP-GLP-1 RA) medication as adjunctive therapy (another treatment used together with the primary treatment) for Crohn's disease patients with mild disease who are on stable doses of biologic medication (infliximab or adalimumab) and who have a body mass index (BMI) of at least 27.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients (≥18 years old)

• Confirmed diagnosis of Crohn's disease

• Mildly active disease, defined by clinical symptoms using the Harvey Bradshaw Index (HBI) score between 5 and 7 (the HBI is a continuous score ranging from 0-16 where \<4 is considered remission)

• BMI ≥ 27 kg/m2

• Patients will be on stable doses of medical therapy (anti-tumor necrosis factor (TNF) alpha blockers)

Locations
United States
Florida
University of Miami
RECRUITING
Miami
Contact Information
Primary
Stephanie Ioannou, MD
s.ioannou@med.miami.edu
305-243-2515
Time Frame
Start Date: 2025-03-05
Estimated Completion Date: 2026-03-05
Participants
Target number of participants: 24
Treatments
Experimental: Tirzepatide group
Participants will be in this group for up to 12 weeks.
Experimental: Mediterranean diet group
Participants will be in this group for up to 12 weeks.
Related Therapeutic Areas
Sponsors
Leads: University of Miami

This content was sourced from clinicaltrials.gov