Preventing early-onset colorectal tumors with tirzepatide

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label Phase 1 exploratory pilot that gives tirzepatide to adults aged 18–50 with recent colon adenomas and collects biospecimens before, during, and after treatment. Investigators will measure biomarkers in stool, urine, blood, oral swabs, tissue, and the gut microbiome to look for changes associated with lowered colorectal cancer risk. The goal is to understand biological mechanisms and the feasibility of a precision prevention approach to inform a larger trial. No blinding or placebo is used, and participants must attend four clinical visits at the study site for sample collection and safety monitoring.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-50 years Because no dosing or adverse event data are currently available on the use of tirzepatide in participants \<18 years of age, children are excluded from this study. Because we are specifically studying the prevention of EOCRC, which is defined as CRC occurring prior to age 50, the study population will only enroll participants under the age of 50 at baseline.
* BMI between 27 and 40 kg/m2
* Underwent a screening or surveillance colonoscopy within the prior 9 months.
* Removal of multiple (at least 2) colon or rectal adenomas (including sessile serrated adenomas but excluding hyperplastic polyps) or a single adenoma ≥6mm in size during the last colonoscopy
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Participants who have ever taken incretin mimetic therapies.
* Participants with a history of medullary thyroid cancer or MEN 2 syndrome.
* Participants at high risk of pancreatitis or otherwise contraindicated for use of tirzepatide according to clinical labeling.
* Participants with a history of cancer (excluding non-melanoma skin) within the last three years
* Participants with a history of diabetes mellitus
* Participants with a history of bowel surgery
* Participants with hereditary cancer syndromes, including HNPCC/Lynch syndrome or familial adenomatous polyposis
* Participants with a history of inflammatory bowel disease, Crohn's, or colitis.
* Participants with incomplete or partial polypectomy during prior colonoscopy.
* Participants who are pregnant. Participants who may become pregnant or partners of those who may become pregnant while on study will receive contraception counseling. Participants or partners of those who become pregnant while participating on the study should immediately inform their doctor.

Where it's running

• Massachusetts General Hospital Cancer Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Andrew T. Chan, MD, MPH — Massachusetts General Hospital
• Study coordinator: Andrew T. Chan, MD, MPH
• Email: achan@mgh.harvard.edu
• Phone: 617-726-3212

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.