Clinical trial
Pathways, Risk Factors, and mOleculeS to Prevent Early-onset Colorectal Tumors
Recruiting now · Phase 1 · 1 countries · Registry ID NCT07095517
Recruiting nowPhase 1Interventional
What this study 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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 50 Years
SexAll
Healthy volunteersNot accepted
ConditionColorectal Cancer Prevention, Colorectal Adenoma
Full registry criteria
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 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 Criteria: * 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.
Treatments and study arms
Tirzepatide
Drug
Study drug injected subcutaneously once a week
Primary outcomes
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.
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Massachusetts General Hospital Cancer Center🇺🇸 Boston, Massachusetts, United States
Andrew T. Chan, MD, MPHContact
Andrew T. Chan, MD, MPHPrincipal Investigator