Tirzepatide for Crohn's Disease

Recruiting at 3 trial locations

Overseen By Darren Nix

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Must not be taking: Hypoglycemic agents, Corticosteroids

Disqualifiers: Ulcerative colitis, Diabetes, Thyroid carcinoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called tirzepatide for people with Crohn's disease, particularly those with difficult-to-treat inflammation in the small bowel. Many current treatments don't work well for everyone, so the study aims to determine if tirzepatide can better heal the intestines. Researchers will monitor participants through surveys, blood tests, and colonoscopies to assess the treatment's effectiveness. This trial suits individuals with Crohn's disease who have tried at least two advanced medications without success and still experience inflammation in their small intestine. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those actively using steroids. It's best to discuss your specific medications with the research team.

Is there any evidence suggesting that tirzepatide is likely to be safe for humans?

Research has shown that tirzepatide, the treatment under study, is generally safe but can cause some side effects. In people with inflammatory bowel disease (IBD), one study found that 58% experienced side effects like nausea, compared to 27% of those without IBD. This suggests that people with IBD might experience more side effects than others. Another report noted higher liver enzyme levels, indicating potential liver effects in some individuals.

Despite these findings, tirzepatide is already used for other conditions, providing some existing safety information. However, treatments can affect everyone differently. Prospective trial participants should discuss any concerns with the research team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Crohn's disease?

Tirzepatide is unique because it offers a novel approach to treating Crohn's Disease by targeting both GLP-1 and GIP receptors, unlike most current treatments that typically focus on reducing inflammation through immunosuppressants or biologics. This dual-action mechanism not only addresses inflammation but also has the potential to improve metabolic parameters, which could be beneficial for Crohn's patients who often struggle with weight and nutritional issues. Researchers are excited about Tirzepatide because it may provide a more comprehensive treatment option, potentially improving both gastrointestinal symptoms and overall health outcomes for patients.

What evidence suggests that tirzepatide might be an effective treatment for Crohn's disease?

Research has shown that tirzepatide, a medication known for aiding weight loss, may also benefit individuals with inflammatory bowel disease (IBD), including Crohn's disease. In earlier studies, individuals with IBD who took tirzepatide lost weight similarly to those without IBD. While the primary focus has been weight management, early results suggest tirzepatide might also reduce intestinal inflammation, a significant issue in Crohn's disease. This trial will assess tirzepatide's effectiveness in managing Crohn's disease compared to the standard of care. Additionally, similar treatments, such as GLP-1 receptor agonists, have improved outcomes for patients, including fewer hospital visits and surgeries. Overall, these early indications suggest tirzepatide might help manage Crohn's disease, but more specific research is necessary. ^{1 3 4 5 6}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with Crohn's disease who have active inflammation in the small bowel and haven't responded to at least two advanced drugs. They must not be pregnant, breastfeeding, or have a BMI under 25. Participants need to agree to birth control requirements if applicable.

Inclusion Criteria

Active ileal or ileocolonic inflammation on colonoscopy defined as Ileal SES-CD > 4 with ulcer subscore > 1 (ulcers > 5mm)

In females: compliance to recommended birth control requirements

I have been diagnosed with Crohn's disease through tests.

Exclusion Criteria

BMI < 25

I am currently pregnant or breastfeeding.

Positive stool test for parasites, C. Diff, or stool culture for pathologic bacteria within 30 days prior to enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tirzepatide to evaluate its efficacy in promoting healing of the affected intestinal segment

8-12 weeks

Regular visits for colonoscopy and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tirzepatide

Trial Overview The study compares standard treatments for Crohn's disease with Tirzepatide, focusing on healing inflamed intestinal segments. It involves interviews about patient well-being, colonoscopy observations, and analysis of blood and stool samples.

How Is the Trial Designed?

Group I: Tirzepatide group Experimental Treatment 1 Intervention

Group II: Standard of Care Arm Active Control 1 Intervention

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40682732/

Efficacy of tirzepatide for weight loss and it's comparative ... TZP use was associated with a similar mean weight loss of > 10% in patients with IBD compared to patients without IBD, however lower compared to WLS.

2. journals.lww.com journals.lww.com/ajg/fulltext/2025/10002/s1890_safety_and_weight_loss_outcomes_of.1891.aspx

S1890 Safety and Weight Loss Outcomes of Tirzepatide in... Conclusion: We show that obesity patients with IBD treated with tirzepatide experience similar weight loss outcomes but significantly more side effects, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06976853

NCT06976853 | Moving Beyond Inflammation as a ... 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 ...

4. academic.oup.com academic.oup.com/ecco-jcc/article/19/9/jjaf167/8256208

Glucagon-like peptide-1 (GLP-1) receptor agonists in ... Early retrospective studies in patients with IBD suggest improved clinical outcomes, such as reduced hospitalization and surgery rates, particularly in those ...

5. gastroendonews.com gastroendonews.com/Inflammatory-Bowel-Disease/Article/05-25/The-Impact-of-GLP-1s-on-Patients-With-IBD/77091

The Impact of GLP-1s on Patients With IBD Obesity, especially when manifested by visceral adipose tissue, seems to be associated with worse IBD outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11540429/

Dramatic Changes in Thiopurine Metabolite Levels in a ... Following tirzepatide initiation, she experienced elevated liver enzymes associated with a significant increase in thiopurine metabolite levels.