Pathways, Risk Factors, and mOleculeS to Prevent Early-onset Colorectal Tumors
Massachusetts General Hospital
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.
Description
In this research study, we are: * Investigating the effects of tirzepatide on biomarkers of colorectal cancer risk in patients with a recent diagnosis of adenoma, a type of intestinal polyp that can precede the development of cancer. * Planning to measure the potential protective effects associated with tirzepatide within biological samples (biospecimens) including stool, urine, blood, and oral swab samples collected prior to, during, and after treatment with tirzepatide. * Tirzepatide is a part of the incretin mimetic (GLP-1 receptor agonist) family, which are typically used for managing dia…
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- No
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 ade…
Interventions
- DrugTirzepatide
Study drug injected subcutaneously once a week
Location
- Massachusetts General Hospital Cancer CenterBoston, Massachusetts