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Early-Onset Colorectal Cancer Prevention Study with Tirzepatide

This research study is looking at how a medication called tirzepatide might help prevent early-onset colorectal cancer. Tirzepatide is typically used for diabetes and weight loss, and researchers want to see if it can also reduce the risk of colorectal cancer by affecting certain biological markers in your body. You may be eligible if you are between 18 and 50 years old and have recently been diagnosed with an adenoma (a type of polyp that can turn into cancer). The study will measure changes in a substance in your urine called PGE-M over 24 weeks to see if tirzepatide has a protective effect. This is a small, exploratory study to help plan for future, larger research. The current status of the study is unclear.

Study design
This is an open-label Phase 1 exploratory/pilot study, meaning everyone knows what treatment is being given. It plans to enroll 20 participants.
What's involved
You would receive tirzepatide injected under your skin once a week. Biological samples like stool, urine, blood, and oral swabs will be collected before, during, and after treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary measurement of urinary PGE-M will be taken from enrollment to the end of treatment at 24 weeks.

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NCT07095517

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

Recruiting
PHASE1Ages 18–50InterventionalPrevention
Massachusetts General Hospital
~20 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:Tirzepatide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Urinary PGE-M
Measured over From enrollment to the end of treatment at 24 weeks

Conditions

Colorectal Cancer Prevention
Colorectal Adenoma

Explore related trials

Colorectal AdenomaColorectal Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Andrew T. Chan, MD, MPH · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Andrew T. Chan, MD, MPH
[email protected]
617-726-3212
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in Urinary PGE-MFrom enrollment to the end of treatment at 24 weeks

    To determine the effect of tirzepatide intervention on urinary prostaglandin metabolites (PGE-M), an established CRC risk biomarker, in context of changes in body weight.