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

NCT07095517 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Colorectal Cancer Prevention
  • Colorectal Adenoma

Interventions

DRUG

Tirzepatide

Study drug injected subcutaneously once a week

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Cancer Research UK

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-24
Primary Completion
2027-03-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07095517 on ClinicalTrials.gov