Pathways, Risk Factors, and mOleculeS to Prevent Early-onset Colorectal Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Tirzepatide
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Cancer Research UK
Collaborator
Source ClinicalTrials.gov