Actively Recruiting

Phase 1
Age: 18Years - 50Years
All Genders
NCT07095517

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

Led by Massachusetts General Hospital · Updated on 2026-02-27

20

Participants Needed

1

Research Sites

148 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 50 years
  • Body mass index (BMI) between 27 and 40 kg/m2
  • Had a screening or surveillance colonoscopy within the past 9 months
  • Removal of multiple (at least 2) colon or rectal adenomas, including sessile serrated adenomas but excluding hyperplastic polyps, or a single adenoma 6 mm or larger during the last colonoscopy
  • Ability to understand and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Ever used incretin mimetic therapies
  • History of medullary thyroid cancer or MEN 2 syndrome
  • High risk of pancreatitis or contraindicated for tirzepatide use
  • History of cancer (excluding non-melanoma skin cancer) within the last 3 years
  • History of diabetes mellitus
  • History of bowel surgery
  • Hereditary cancer syndromes such as HNPCC/Lynch syndrome or familial adenomatous polyposis
  • History of inflammatory bowel disease, Crohn's disease, or colitis
  • Incomplete or partial polypectomy during prior colonoscopy
  • Pregnancy or may become pregnant during the study without contraception counseling

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

A

Andrew T. Chan, MD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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