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Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease
Lead sponsor
Asset
Tirzepatide
Subcutaneous · GLP-1 / GIP dual
Listed sites
3
Recruiting sites
2
Enrollment
60
estimated
Study population
Gastrointestinal (gastroparesis / short bowel / pancreatitis)
Key I/E criterion
—
Primary endpoints
•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious AEs (any), Discontinuation due to AE)•Number of participants who achieve various doses of Tirzepatide at increments•Proportion and number of participants with endoscopic remission
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (9)
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
Weight & body composition
1 endpointProportion 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
threshold achievement, improvement
componentsVisceral fat, change, Total fat mass
Patient-reported / QoL
1 endpointProportion 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
threshold achievement, improvement
Safety / tolerability / PK
2 endpointsProportion 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
Treatment-emergent AEs (any)
descriptive
componentsTreatment-emergent AEs (any), Serious AEs (any), Discontinuation due to AE
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
descriptive
Other clinical outcomes
4 endpointsProportion 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
threshold achievement, improvement
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
threshold achievement, improvement
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
threshold achievement, improvement
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
threshold achievement, improvement
Other (unclassified)
1 endpointRates 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
threshold achievement, improvement
Provenance
Sources
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 1, 2026 snapshot.