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

NCT06976853 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 202504106
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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. 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)

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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.

  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%)

  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

  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

  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

  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

  From enrollment to the end of treatment at month 7

Study Arms (2)

Tirzepatide group

EXPERIMENTAL

Drug: Tirzepatide

Standard of Care Arm

ACTIVE COMPARATOR

Drug: Standard of care treatment

Interventions

Tirzepatide DRUG

Addition of tirzepatide to current biological therapy

Tirzepatide group

Standard of care treatment DRUG

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

Standard of Care Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. 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
• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (3)

Cedars-Sinai Medical Center

Beverly Hills, California, 90211, United States

NOT YET RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Parakkal Deepak, MBBS, MS

  Washington University School of Medicine GI Division

  PRINCIPAL INVESTIGATOR

• Louis Cohen, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Andres Yarur, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monique Lavalas Bright

CONTACT

314-362-9044; lavalas@wustl.edu

Darren Nix

CONTACT

314-362-3201; nixd@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 16, 2025
• Study Start: May 13, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

US (3)