RecruitingPhase 1NCT07095517

Pathways, Risk Factors, and mOleculeS to Prevent Early-onset Colorectal Tumors


Sponsor

Massachusetts General Hospital

Enrollment

20 participants

Start Date

Feb 24, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This research study is an open-label Phase 1 Exploratory/Pilot clinical trial to measure the effects of the incretin mimetic, tirzepatide, on tissue, urine, blood, and microbiome biomarkers associated with colorectal cancer risk and to understand the feasibility of this precision prevention trial approach for a future larger study.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether tirzepatide — a medication currently used for diabetes and weight loss — can help prevent colorectal cancer in younger adults (under 50) who are at elevated risk because they have had colon polyps removed. The study focuses specifically on early-onset colorectal cancer prevention. **You may be eligible if...** - You are between 18 and 50 years old - Your body mass index (BMI) is between 27 and 40 - You had a colonoscopy within the past 9 months and had at least two polyps removed, or one polyp that was 6mm or larger - You have never taken GLP-1 or GIP medications (e.g., semaglutide, tirzepatide, Ozempic, Mounjaro) **You may NOT be eligible if...** - You have a history of medullary thyroid cancer or a condition called MEN 2 syndrome - You have a high risk of pancreatitis or other reasons tirzepatide is contraindicated for you - You have been diagnosed with diabetes, cancer (in the past 3 years), or inflammatory bowel disease - You have a hereditary colon cancer syndrome (e.g., Lynch syndrome, familial adenomatous polyposis) - You have had bowel surgery - You are pregnant or may become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTirzepatide

Study drug injected subcutaneously once a week


Locations(1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

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NCT07095517


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