Crohn DiseasePhase 4NCT06774079
Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
A Phase 4 study testing Tirzepatide and Mediterranean diet in people with Crohn Disease, run by University of Miami at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Tirzepatide and Mediterranean diet
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2025to 5 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- Tirzepatide, Mediterranean diet
- Keywords
- inflammatory bowel disease
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
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.
Mediterranean dietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide group | Experimental | Participants will be in this group for up to 12 weeks. Receives: Drug: Tirzepatide; Behavioral: Mediterranean diet |
| Mediterranean diet group | Experimental | Participants will be in this group for up to 12 weeks. Receives: Behavioral: Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentage of participants retained
The percentage of participants retained will be measured
Measured: Baseline, 12 weeks
Number of patients who adhere to diet measured by 24 hour dietary recall
Number of patients who adhere to diet measured by 24 hour dietary recall
Measured: Up to 12 weeks
Number of patients who adhere to medications measured by self report
Number of patients who adhere to medications measured by self report
Measured: Up to 12 weeks
Secondary outcomes (5)
Number of calls completed
Number of calls completed. Calls will be made either on a phone or virtually using Zoom.
Measured: Up to 12 weeks
Number of dietary recall (ASA24) surveys completed
Number of dietary recall (ASA24) surveys completed
Measured: Up to 12 weeks
Number of clinical symptom (HBI/CDAI) surveys completed
Number of clinical symptom (HBI/CDAI) surveys completed
Measured: Up to 12 weeks
Number of blood samples completed
Number of blood samples completed
Measured: Up to 12 weeks
Number of stool samples completed
Number of stool samples completed
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start5 Mar 2025
- Primary completion5 Mar 2027 (estimated)
- Study completion5 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oriana Mazorra Damas, University of Miami
- Investigators
- Oriana Damas, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774079
- Sponsor's protocol ID
- 20240982
- Status last verified
- Oct 2026
- First submitted
- 8 Jan 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06774079
- Acronym / sponsor ID
- 20240982
- Conditions
- Crohn Disease
- Keywords
- inflammatory bowel disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 5 Mar 2027 (estimated)
- Study completion
- 5 Mar 2027 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide group | Experimental | Drug: Tirzepatide, Behavioral: Mediterranean dietParticipants will be in this group for up to 12 weeks. |
| Mediterranean diet group | Experimental | Behavioral: Mediterranean dietParticipants will be in this group for up to 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatidePatients 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. | Drug | Tirzepatide group |
| Mediterranean dietThe 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. | Behavioural | Mediterranean diet group, Tirzepatide group |
Primary outcome
Change in percentage of participants retained
Time frame: Baseline, 12 weeks
The percentage of participants retained will be measured
Number of patients who adhere to diet measured by 24 hour dietary recall
Time frame: Up to 12 weeks
Number of patients who adhere to diet measured by 24 hour dietary recall
Number of patients who adhere to medications measured by self report
Time frame: Up to 12 weeks
Number of patients who adhere to medications measured by self report
5 secondary outcomes
Number of calls completed
Time frame: Up to 12 weeks
Number of dietary recall (ASA24) surveys completed
Time frame: Up to 12 weeks
Number of clinical symptom (HBI/CDAI) surveys completed
Time frame: Up to 12 weeks
Number of blood samples completed
Time frame: Up to 12 weeks
Number of stool samples completed
Time frame: Up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oriana Damas, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tirzepatide and Mediterranean diet in people with Crohn Disease, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percentage of participants retained (time frame: Baseline, 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.