Crohn Disease (CD)Phase 2NCT06976853
Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease
A Phase 2 study testing Tirzepatide in people with Crohn Disease (CD), run by Washington University School of Medicine at 3 sites in United States.
Trial summary
The purpose of this research study is to evaluate what type of treatment will be beneficial for people with Crohn's disease and difficult to treat inflammation in the small bowel. Current therapies are used to control the inflammation due to Crohn's disease in your digestive tract. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn Disease (CD)
- What is being tested?
- Tirzepatide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 May 2025to Aug 2028
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 18 to 80 years of age, inclusive, at the time of consent
- Confirmed diagnosis of Crohn's disease based on documented findings on endoscopy and histopathology
- Active ileal or ileocolonic inflammation on colonoscopy defined as
- 1. Ileal SES-CD > 4 with ulcer subscore > 1 (ulcers > 5mm)
- Failure to respond to (primary or secondary non-response) at least 2 advanced class drugs, without evidence of immunogenicity (anti-TNFa only). Must have been at least 6 months optimized on most recent therapy without corticosteroids.
- Anti-TNF: Infliximab, Adalimumab, Certolizumab, Golimumab
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- Anti-integrin agent: vedolizumab
- Anti-IL12/23 agent: Ustekinumab
- Anti-IL23: Risankizumab, Guselkumab, Mirikizumab
- JAK inhibitor: Upadacitinib
- In post surgical patients, must be at least 6 months post-op with endoscopic evidence of ileal disease
- In females: compliance to recommended birth control requirements
Who cannot join
- Age < 18 or > 80 years
- Pregnant or Breastfeeding female
- Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease-associated colitis, toxic megacolon, active infectious colitis or positive test for Clostridioides Difficile toxin at screening
- BMI < 25
- Current or previous diagnosis of anorexia nervosa
- Type 1 or Type 2 diabetes
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- Use of concomitant hypoglycemic agents
- Personal or family history of medullary thyroid carcinoma
- History of multiple endocrine neoplasia
- Known serious hypersensitivity to tirzepatide or any of its excipients
- Have functional or post-operative short-bowel syndrome
- Had intestinal resection ≤ 24 weeks prior to inclusion or other intra-abdominal surgeries ≤ 12 weeks prior to study inclusion
- Active treatment with steroids*
- Positive stool test for parasites, C. Diff or stool culture for pathologic bacteria within 30 days prior to enrollment
- Current stricture not passable with an endoscope
- Impending need for surgery per investigator
- Have an ileostomy or a colostomy
- In females: refusal to comply to recommended birth control requirements *Corticosteroids have metabolic and hormonal effects which we are concerned may interfere with study outcomes and metabolic changes in the population. This exclusion criteria will allow the study population to be standardized across all patients
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Cedars-Sinai Medical Center
Beverly Hills, California, 90211
Martha Bucaram, 310-423-0035, Martha.Bucaram@cshs.org
Andres Yarur, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Katha Makwana, 212-327-8270, Katha.makwana@mssm.edu
Louis Cohen, MD
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Monique Lavalas Bright, 314-362-9044, lavalas@wustl.edu
Parakkal Deepak, MBBS, MS
About this study
The purpose of this research study is to evaluate what type of treatment will be beneficial for people with Crohn's disease and difficult to treat inflammation in the small bowel. Current therapies are used to control the inflammation due to Crohn's disease in your digestive tract. In some patients, those therapies are not sufficient to fully treat the disease. This objective of this study is to evaluate the efficacy of a different type of therapy, tirzepatide, that may promote healing of the affected intestinal segment. To evaluate the efficacy of this medication, a member of the research team will ask patients questions about how they feel and observe whether this medication heals the their bowel at colonoscopy. A member of the research team will also use blood samples, stool samples and samples of the small intestine taken during a colonoscopy to understand how tirzepatide helps heal the intestine.
- Conditions
- Crohn Disease (CD)
- Being tested
- Tirzepatide, Standard of care treatment
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Addition of tirzepatide to current biological therapy
Standard of care treatmentDrug
Intervention will be to change patient's current therapy to a 3rd or later advanced biologic patient have never been exposed to
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide group | Experimental | Not described Receives: Drug: Tirzepatide |
| Standard of Care Arm | Active comparator | Not described Receives: Drug: Standard of care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion and number of participants who have treatment emergent adverse events, serious adverse events, discontinuation of study intervention due to adverse events and injection-site reactions by CTCAE v4.0
Measured: From enrollment to the end of treatment at month 7
Number of participants who achieve various doses of Tirzepatide at increments of 2.5 mg, up to 15 mg
Measured: From enrollment to the end of treatment at month 7
Proportion and number of participants with endoscopic remission as defined by SES-CD < 4 with no ulcer subscore >1.
Measured: From enrollment to the end of treatment at month 7
Secondary outcomes (6)
Proportion and number of participants with endoscopic response as defined by (↓SES-CD 50%)
Measured: From enrollment to the end of treatment at month 7
Proportion and number of participants who achieve clinical remission/response defined by Crohn's disease activity index < 150 for clinical remission or a decrease from baseline by at least 100 points on CDAI
Measured: From enrollment to the end of treatment at month 7
Proportion and number of participants who achieve clinical remission defined by a Harvey Bradshaw Index < 5
Measured: From enrollment to the end of treatment at month 7
Proportion and number of participants who achieve improvement from baseline in the Short Inflammatory Bowel Disease Quality of Life Questionnaire in four domains, bowel symptoms, emotional health, systemic systems and social function. Questions are score
Measured: From enrollment to the end of treatment at month 7
Proportion and number of participants who achieve improvement from baseline in visceral adipose tissue, the total body fat percentage, fat mass index by DEXA
Measured: From enrollment to the end of treatment at month 7
Rates of remission in each group (3rd advanced therapy, tirzepatide 5mg dosing, tirzepatide escalated dosing)
Measured: From enrollment to the end of treatment at month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start13 May 2025
- Primary completionMay 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parakkal Deepak, MBBS, MS, Principal investigator, Washington University School of Medicine GI DivisionLouis Cohen, MD, Principal investigator, Icahn School of Medicine at Mount SinaiAndres Yarur, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976853
- Sponsor's protocol ID
- 202504106
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease
- ClinicalTrials.gov ID
- NCT06976853
- Acronym / sponsor ID
- 202504106
- Conditions
- Crohn Disease (CD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 16 May 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 research study is to evaluate what type of treatment will be beneficial for people with Crohn's disease and difficult to treat inflammation in the small bowel. Current therapies are used to control the inflammation due to Crohn's disease in your digestive tract. In some patients, those therapies are not sufficient to fully treat the disease. This objective of this study is to evaluate the efficacy of a different type of therapy, tirzepatide, that may promote healing of the affected intestinal segment. To evaluate the efficacy of this medication, a member of the research team will ask patients questions about how they feel and observe whether this medication heals the their bowel at colonoscopy. A member of the research team will also use blood samples, stool samples and samples of the small intestine taken during a colonoscopy to understand how tirzepatide helps heal the intestine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide group | Experimental | Drug: Tirzepatide |
| Standard of Care Arm | Active comparator | Drug: Standard of care treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects 18 to 80 years of age, inclusive, at the time of consent
- Confirmed diagnosis of Crohn's disease based on documented findings on endoscopy and histopathology
- Active ileal or ileocolonic inflammation on colonoscopy defined as
- 1. Ileal SES-CD > 4 with ulcer subscore > 1 (ulcers > 5mm)
- Failure to respond to (primary or secondary non-response) at least 2 advanced class drugs, without evidence of immunogenicity (anti-TNFa only). Must have been at least 6 months optimized on most recent therapy without corticosteroids.
Key exclusion criteria (18 listed)
- Age < 18 or > 80 years
- Pregnant or Breastfeeding female
- Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease-associated colitis, toxic megacolon, active infectious colitis or positive test for Clostridioides Difficile toxin at screening
- BMI < 25
- Current or previous diagnosis of anorexia nervosa
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 |
|---|---|---|
| TirzepatideAddition of tirzepatide to current biological therapy | Drug | Tirzepatide group |
| Standard of care treatmentIntervention will be to change patient's current therapy to a 3rd or later advanced biologic patient have never been exposed to | Drug | Standard of Care Arm |
Primary outcome
Proportion and number of participants who have treatment emergent adverse events, serious adverse events, discontinuation of study intervention due to adverse events and injection-site reactions by CTCAE v4.0
Time frame: From enrollment to the end of treatment at month 7
Number of participants who achieve various doses of Tirzepatide at increments of 2.5 mg, up to 15 mg
Time frame: From enrollment to the end of treatment at month 7
Proportion and number of participants with endoscopic remission as defined by SES-CD < 4 with no ulcer subscore >1.
Time frame: From enrollment to the end of treatment at month 7
6 secondary outcomes
Proportion and number of participants with endoscopic response as defined by (↓SES-CD 50%)
Time frame: From enrollment to the end of treatment at month 7
Proportion and number of participants who achieve clinical remission/response defined by Crohn's disease activity index < 150 for clinical remission or a decrease from baseline by at least 100 points on CDAI
Time frame: From enrollment to the end of treatment at month 7
Proportion and number of participants who achieve clinical remission defined by a Harvey Bradshaw Index < 5
Time frame: From enrollment to the end of treatment at month 7
Proportion and number of participants who achieve improvement from baseline in the Short Inflammatory Bowel Disease Quality of Life Questionnaire in four domains, bowel symptoms, emotional health, systemic systems and social function. Questions are score
Time frame: From enrollment to the end of treatment at month 7
Proportion and number of participants who achieve improvement from baseline in visceral adipose tissue, the total body fat percentage, fat mass index by DEXA
Time frame: From enrollment to the end of treatment at month 7
Rates of remission in each group (3rd advanced therapy, tirzepatide 5mg dosing, tirzepatide escalated dosing)
Time frame: From enrollment to the end of treatment at month 7
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 5 Jun 2026.
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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.
Parakkal Deepak, MBBS, MS principal investigator
Washington University School of Medicine GI Division
Louis Cohen, MD principal investigator
Icahn School of Medicine at Mount Sinai
Andres Yarur, MD principal investigator
Cedars-Sinai Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tirzepatide in people with Crohn Disease (CD), run by Washington University School of Medicine at 3 sites 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 12 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Monique Lavalas Bright (314-362-9044, lavalas@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion and number of participants who have treatment emergent adverse events, serious adverse events, discontinuation of study intervention due to adverse events and injection-site reactions by CTCAE v4.0 (time frame: From enrollment to the end of treatment at month 7). 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 5 Jun 2026.