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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07095517
Phase
PHASE1
Status
Recruiting
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Conditions

  • Colorectal Adenoma
  • Colorectal Cancer Prevention

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Study drug injected subcutaneously once a week

Study Details

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.

Key Dates

Start date
Feb 24, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Tirzepatide
    Participants will be instructed to inject tirzepatide 1 time per week for up to 24 weeks. The dose will start with a 2.5mg injection per week for the first 4 weeks. Dose will increase 2.5mg/injection every 4 weeks until 15mg/injection (or maximum tolerable dose) per week is reached.

Primary Outcome Measure

Change in Urinary PGE-M [ Time Frame: From enrollment to the end of treatment at 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114
Andrew T. Chan, MD, MPH
[email protected]
617-726-3212
Andrew T. Chan, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts General Hospital Cancer Center· Boston, MA

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