Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease

Q: Who can participate in NCT06976853?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT06976853?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease (NCT06976853) is a Phase 2 interventional studying Crohn Disease (CD), sponsored by Washington University School of Medicine. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Crohn Disease (CD) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Crohn Disease (CD) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Subjects 18 to 80 years of age, inclusive, at the time of consent 2. Confirmed diagnosis of Crohn's disease based on documented findings on endoscopy and histopathology 3. Active ileal or ileocolonic inflammation on colonoscopy defined as 1\. Ileal SES-CD \> 4 with ulcer subscore \> 1 (ulcers \> 5mm) 4. 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. 1. Anti-TNF: Infliximab, Adalimumab, Certolizumab, Golimumab 2. Anti-integrin agent: vedolizumab 3. Anti-IL12/23 agent: Ustekinumab 4. Anti-IL23: Risankizumab, Guselkumab, Mirikizumab 5. JAK inhibitor: Upadacitinib 5. In post surgical patients, must be at least 6 months post-op with endoscopic evidence of ileal disease 6. In females: compliance to recommended birth control requirements Who Should NOT Join This Trial: 1. Age \< 18 or \> 80 years 2. Pregnant or Breastfeeding female 3. 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 4. BMI \< 25 5. Current or previous diagnosis of anorexia nervosa 6. Type 1 or Type 2 diabetes 7. Use of concomitant hypoglycemic agents 8. Personal or family history of medullary thyroid carcinoma 9. History of multiple endocrine neoplasia 10. Known serious hypersensitivity to tirzepatide or any of its excipients 11. Have functional or post-operative short-bowel syndrome 12. Had intestinal resection ≤ 24 weeks prior to inclusion or other intra-abdominal surgeries ≤ 12 weeks prior to study inclusion 13. Active treatment with steroids\* 14. Positive stool test for parasites, C. Diff or stool culture for pathologic bacteria within 30 days prior to enrollment ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Subjects 18 to 80 years of age, inclusive, at the time of consent 2. Confirmed diagnosis of Crohn's disease based on documented findings on endoscopy and histopathology 3. Active ileal or ileocolonic inflammation on colonoscopy defined as 1\. Ileal SES-CD \> 4 with ulcer subscore \> 1 (ulcers \> 5mm) 4. 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. 1. Anti-TNF: Infliximab, Adalimumab, Certolizumab, Golimumab 2. Anti-integrin agent: vedolizumab 3. Anti-IL12/23 agent: Ustekinumab 4. Anti-IL23: Risankizumab, Guselkumab, Mirikizumab 5. JAK inhibitor: Upadacitinib 5. In post surgical patients, must be at least 6 months post-op with endoscopic evidence of ileal disease 6. In females: compliance to recommended birth control requirements Exclusion Criteria: 1. Age \< 18 or \> 80 years 2. Pregnant or Breastfeeding female 3. 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 4. BMI \< 25 5. Current or previous diagnosis of anorexia nervosa 6. Type 1 or Type 2 diabetes 7. Use of concomitant hypoglycemic agents 8. Personal or family history of medullary thyroid carcinoma 9. History of multiple endocrine neoplasia 10. Known serious hypersensitivity to tirzepatide or any of its excipients 11. Have functional or post-operative short-bowel syndrome 12. Had intestinal resection ≤ 24 weeks prior to inclusion or other intra-abdominal surgeries ≤ 12 weeks prior to study inclusion 13. Active treatment with steroids\* 14. Positive stool test for parasites, C. Diff or stool culture for pathologic bacteria within 30 days prior to enrollment 15. Current stricture not passable with an endoscope 16. Impending need for surgery per investigator 17. Have an ileostomy or a colostomy 18. 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

Treatments Being Tested

DRUG

Tirzepatide

Addition of tirzepatide to current biological therapy

DRUG

Standard of care treatment

Intervention will be to change patient's current therapy to a 3rd or later advanced biologic patient have never been exposed to

Locations (3)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Cedars-Sinai Medical Center

Beverly Hills, California, United States

Washington University School of Medicine

St Louis, Missouri, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06976853), the sponsor (Washington University School of Medicine), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06976853 clinical trial studying?

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 tea… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06976853?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06976853?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06976853. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06976853. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.