RecruitingPhase 4

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

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

Lead sponsor

University of Miami

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

Study population

Gastrointestinal (gastroparesis / short bowel / pancreatitis)

Eligibility highlights

•BMI ≥27

Primary endpoints

•Percentage of participants retained•Number of patients who adhere to diet•Number of patients who adhere to medications

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06774079

Org study ID20240982

Timeline

Milestones

Study first posted2025-01-14actual

Study start2025-03-05actual

Last update posted2026-03-30actual

Primary completion2027-03-05estimated

Study completion2027-03-05estimated

Assets

Investigational agents

Tirzepatide

Who this study enrolls

Gastrointestinal (gastroparesis / short bowel / pancreatitis)

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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)

Exclusion criteria

•Patients under 18 years of age

•Patients with ulcerative colitis

•Patients with infectious colitis

•BMI<27 kg/m2

•Patients with type 1 or type 2 diabetes

•Contraindications to a GIP/GLP-1 RA, including patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2

•Patients already on GIP/GLP-1 RA therapy

•Patients with the following chronic symptoms: severe constipation, nausea, and/or vomiting

•Patients with the following medical history: small bowel obstruction in the last year, intestinal stricture, known or suspected diagnosis of gastroparesis

•Adults unable to consent

•Pregnant patients (will be confirmed via a pregnancy test)

•Prisoners

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

Other clinical outcomes

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Number of blood samples completed

Time frame:Up to 12 weeks

descriptive

Other clinical outcomes

1 endpoint

Primary/protocol endpoint

Number of patients who adhere to diet measured by 24 hour dietary recall

Time frame:Up to 12 weeks

threshold achievement, improvement

Other (unclassified)

6 endpoints

Primary/protocol endpoint/low confidence

Change in percentage of participants retained

Time frame:Baseline, 12 weeks

descriptive

Primary/protocol endpoint/low confidence

Number of patients who adhere to medications measured by self report

Time frame:Up to 12 weeks

descriptive

Secondary/protocol endpoint/low confidence

Number of calls completed

Time frame:Up to 12 weeks

descriptive

Secondary/protocol endpoint

Number of dietary recall (ASA24) surveys completed

Time frame:Up to 12 weeks

descriptive

Secondary/protocol endpoint

Number of clinical symptom (HBI/CDAI) surveys completed

Time frame:Up to 12 weeks

descriptive

Secondary/protocol endpoint/low confidence

Number of stool samples completed

Time frame:Up to 12 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.