Crohn Disease (CD)
Tirzepatide or Advanced Biologic Therapy for Difficult-to-Treat Crohn's Disease
This randomized phase 2 study is investigating tirzepatide added to current biologic therapy versus changing to another advanced biologic in adults with Crohn's disease and persistent ileal or ileocolonic inflammation.
Registry title: Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease
3 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–80 Years
- Treatment
- Tirzepatide or Standard of care treatment
- Design
- Randomized
- Central study contact
- Monique Lavalas Bright314-362-9044lavalas@wustl.edu
- Sponsor
- Washington University School of Medicine
Research question
Does adding tirzepatide to current biologic therapy, compared with changing to another advanced biologic, produce acceptable safety, tolerability, and bowel-healing outcomes in difficult-to-treat Crohn's disease?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 80 with Crohn's disease confirmed by endoscopy and tissue examination.
- Participants must have active inflammation in the ileum or ileum and colon, with ulcers meeting the study's colonoscopy criteria.
- Participants must have failed to respond to at least two classes of advanced drugs and have spent at least six months on an optimized recent therapy without corticosteroids.
- Study locations are listed in St. Louis and New York as recruiting; the Beverly Hills location is listed as not yet recruiting.
Participation overview
What participation may involve
Participants are randomized either to add tirzepatide to their current biologic therapy or to change to another advanced biologic. The study evaluates adverse events, dosing, bowel healing, Crohn's symptoms, quality of life, and body composition. What participation may involve: - Receive the assigned treatment: tirzepatide added to current biologic therapy or a change to an advanced biologic not previously received. - Answer questions about symptoms and quality of life. - Undergo colonoscopy assessment of bowel healing, with small-intestine tissue samples collected during colonoscopy. - Provide blood and stool samples for research on intestinal healing. - Have adverse events, serious adverse events, treatment discontinuations, and injection-site reactions assessed. - Have body composition evaluated by dual-energy X-ray absorptiometry (DEXA). The reported outcome assessments run from enrollment through the end of treatment at month 7.
Study interventions
What participants may receive or do
- Tirzepatide: Participants assigned to this group receive tirzepatide in addition to their current biologic therapy. The registry reports dose increases of 2.5 mg, up to 15 mg, as an outcome being studied.
- Standard of care treatment: Participants assigned to this group change from their current therapy to a third or later advanced biologic that they have not previously received.
Study design
How the comparison works
This is an open-label, randomized, parallel-group phase 2 treatment study with an estimated enrollment of 60 participants. It compares a tirzepatide group with an active standard-of-care group. Participants are assigned at random to one of two parallel treatment groups. The registry does not report the allocation ratio. The study has no masking, meaning the registry does not describe participants or study personnel as blinded to treatment assignment. The comparison group receives standard-of-care treatment by changing to a third or later advanced biologic not previously used by that participant. No placebo or sham intervention is listed; both study groups are described as receiving active treatment.
Reported activities
Procedures and tests
- Colonoscopy is used to assess ileal or ileocolonic inflammation and bowel healing.
- Small-intestine tissue samples are collected during colonoscopy for research on intestinal healing.
- Blood samples are collected for research on intestinal healing.
- Stool samples are collected, and eligibility criteria refer to testing for parasites, Clostridioides difficile, and disease-causing bacteria.
- Symptoms are assessed using the Crohn's Disease Activity Index and Harvey-Bradshaw Index.
- Quality of life is assessed with the Short Inflammatory Bowel Disease Quality of Life Questionnaire.
- Dual-energy X-ray absorptiometry (DEXA) is used to assess visceral fat, total body-fat percentage, and fat mass index.
- Adverse events, serious adverse events, treatment discontinuations due to adverse events, and injection-site reactions are monitored.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 18 through 80 years old when they provide consent.
- Crohn's disease must be confirmed by documented endoscopy and tissue-examination findings.
- Colonoscopy must show active ileal or ileocolonic inflammation, with an ileal Simple Endoscopic Score for Crohn's Disease above 4 and an ulcer subscore above 1.
- Participants must have had primary or secondary non-response to at least two classes of advanced drugs; for anti-tumor necrosis factor therapy, this must be without evidence of immunogenicity.
- The most recent therapy must have been optimized for at least six months without corticosteroids.
- After Crohn's-related surgery, participants must be at least six months past the operation and have endoscopic evidence of ileal disease.
- Female participants must follow the recommended birth-control requirements.
Possible reasons someone may not be able to join
- Pregnant or breastfeeding women are excluded.
- People with specified other forms of colitis, toxic megacolon, active infectious colitis, or a positive Clostridioides difficile toxin test at screening are excluded.
- A body mass index below 25 excludes participation.
- People with type 1 or type 2 diabetes, or who use glucose-lowering medications, are excluded.
- A personal or family history of medullary thyroid carcinoma or a history of multiple endocrine neoplasia excludes participation.
- People with functional or postoperative short-bowel syndrome are excluded.
- Intestinal resection within 24 weeks or another abdominal operation within 12 weeks before study inclusion excludes participation.
- People receiving active steroid treatment are excluded.
- A positive stool test for parasites, Clostridioides difficile, or disease-causing bacteria within 30 days before enrollment excludes participation.
- People are excluded if they have a current narrowing that an endoscope cannot pass, an impending need for surgery, an ileostomy, or a colostomy.
Important unknowns
What the record does not make clear
- The registry does not state how many in-person or remote visits are required or when they occur.
- Outcome timeframes identify treatment through month 7, but the registry does not clarify whether follow-up continues afterward.
- Tirzepatide is added to current biologic therapy, while the comparison group changes therapy, but the registry does not fully describe which other Crohn's medicines may continue in either group.
- The criteria exclude active steroid treatment and require six months of optimized recent therapy without corticosteroids, but no specific washout schedule is reported.
- The registry does not state what treatment is available if Crohn's disease worsens during the study.
- The registry describes colonoscopy for confirming active disease and evaluating healing but does not report the total number or timing of colonoscopies.
- The registry does not state which study treatments, procedures, or routine-care costs are paid by the study or billed to insurance.
- The registry does not report whether participants receive compensation.
- The registry does not report reimbursement or support for transportation, lodging, parking, or meals.
- The registry does not state whether any visits or assessments can be completed remotely.
- The registry does not describe access to tirzepatide or the assigned advanced biologic after study treatment ends.
- The overall study is recruiting, but Beverly Hills is listed as not yet recruiting while St. Louis and New York are listed as recruiting; current openings still require confirmation.
Before contacting the site
Questions for the study team
- How many visits, colonoscopies, blood draws, stool collections, DEXA scans, and questionnaires are required, and when do they occur?
- How is tirzepatide given, how often is it taken, and how are dose increases from 2.5 mg up to 15 mg decided?
- Which current Crohn's medicines continue in the tirzepatide group, and how is the replacement biologic selected in the standard-of-care group?
- What happens if symptoms or bowel inflammation worsen during the seven-month treatment period?
- Which study treatments and procedures are paid for, what may be billed to insurance, and is compensation or travel support available?
- Does follow-up continue after month 7, and what treatment access or care transition is offered when study treatment ends?
- Is my preferred study location currently enrolling, and can any assessments be completed remotely?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn's disease now, and what are the risks of continuing my current biologic while adding tirzepatide?
- Which approved advanced biologics that I have not tried remain reasonable alternatives for my disease history?
- Would changing or stopping any of my current medicines create concerns, and how should medication changes be coordinated with the research team?
- Are there features of my Crohn's disease, prior surgeries, strictures, ostomy status, or possible need for surgery that I should discuss with the study team?
- How should my regular Crohn's monitoring and urgent care be coordinated between your office and the research team?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
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.
Study design and administration
- Organization
- Washington University School of Medicine
- Organization class
- Other
- Organization study ID
- 202504106
- Lead sponsor
- Washington University School of Medicine
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Tirzepatide group
Interventions: Drug: Tirzepatide
Active Comparator
Standard of Care Arm
Interventions: Drug: Standard of care treatment
Interventions
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
Eligibility
18 Years–80 Years
All
Not accepted
Inclusion criteria (18)
- Subjects 18 to 80 years of age, inclusive, at the time of consentRegistry-derived · unreviewed
- Confirmed diagnosis of Crohn's disease based on documented findings on endoscopy and histopathologyRegistry-derived · unreviewed
- Active ileal or ileocolonic inflammation on colonoscopy defined asRegistry-derived · unreviewed
- 1\. Ileal SES-CD \> 4 with ulcer subscore \> 1 (ulcers \> 5mm)Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Anti-TNF: Infliximab, Adalimumab, Certolizumab, GolimumabRegistry-derived · unreviewed
- Anti-integrin agent: vedolizumabRegistry-derived · unreviewed
- Anti-IL12/23 agent: UstekinumabRegistry-derived · unreviewed
- Anti-IL23: Risankizumab, Guselkumab, MirikizumabRegistry-derived · unreviewed
- JAK inhibitor: UpadacitinibRegistry-derived · unreviewed
- In post surgical patients, must be at least 6 months post-op with endoscopic evidence of ileal diseaseRegistry-derived · unreviewed
- In females: compliance to recommended birth control requirementsRegistry-derived · unreviewed
- Active treatment with steroids\*Registry-derived · unreviewed
- Positive stool test for parasites, C. Diff or stool culture for pathologic bacteria within 30 days prior to enrollmentRegistry-derived · unreviewed
- Current stricture not passable with an endoscopeRegistry-derived · unreviewed
- Impending need for surgery per investigatorRegistry-derived · unreviewed
- Have an ileostomy or a colostomyRegistry-derived · unreviewed
- 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 patientsRegistry-derived · unreviewed
Exclusion criteria (11)
- Age \< 18 or \> 80 yearsRegistry-derived · unreviewed
- Pregnant or Breastfeeding femaleRegistry-derived · unreviewed
- 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 screeningRegistry-derived · unreviewed
- BMI \< 25Registry-derived · unreviewed
- Current or previous diagnosis of anorexia nervosaRegistry-derived · unreviewed
- Type 1 or Type 2 diabetesRegistry-derived · unreviewed
- Use of concomitant hypoglycemic agentsRegistry-derived · unreviewed
- Personal or family history of medullary thyroid carcinomaRegistry-derived · unreviewed
- History of multiple endocrine neoplasiaRegistry-derived · unreviewed
- Known serious hypersensitivity to tirzepatide or any of its excipientsRegistry-derived · unreviewed
- Have functional or post-operative short-bowel syndromeRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
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
Primary outcome
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
Primary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Recruiting locations in the United States
Cedars-Sinai Medical Center
Not Yet RecruitingBeverly Hills, California, 90211, United States
Martha Bucaram310-423-0035Martha.Bucaram@cshs.org
Andres Yarur, MD
Washington University School of Medicine
RecruitingSt Louis, Missouri, 63110, United States
Monique Lavalas Bright314-362-9044lavalas@wustl.edu
Parakkal Deepak, MBBS, MS
Icahn School of Medicine at Mount Sinai
RecruitingNew York, New York, 10029, United States
Katha Makwana212-327-8270Katha.makwana@mssm.edu
Louis Cohen, MD
Central study contacts
Registry dates
- First posted
- May 16, 2025
- Primary completion
- May 2028
- Overall completion
- Aug 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.