MedTrace Logo

Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients

NCT06774079 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-03-30

No results posted yet for this study

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.

Conditions

  • Crohn Disease

Interventions

DRUG

Tirzepatide

Patients in this arm will receive tirzepatide starting at 2.5 mg subcutaneous (SC) weekly for 4 weeks, then increase to 5 mg SC weekly for 4 weeks and then 7.5 mg SC weekly for the last 4 weeks of the intervention period. Place of injection includes abdomen, thigh, or upper arm.

BEHAVIORAL

Mediterranean diet

The diet is comprised of a content of 25-30 grams of fiber per day (from fruits, vegetables, whole grains) that is low in animal protein and minimally processing of foods The diet arm will receive dietary guidance from our dietician on weekly 30-minute guided sessions. Participants will be encouraged to adhere to the diet for up to three meals per day for the duration of the study.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Oriana Damas, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-05
Primary Completion
2027-03-05
Completion
2027-03-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06774079 on ClinicalTrials.gov