This phase I trial tests the effect of tirzepatide in preventing early-onset colorectal cancer (CRC) in patients recently diagnosed with an abnormal growth of tissue in the colon or rectum (adenoma). Precancerous colorectal adenomas are responsible for the majority of CRC and diagnosis in patients under the age of 50 (early-onset) is steadily increasing. Lifestyle and metabolic factors, such as weight and diet, may also contribute to the rising rates of early-onset diagnosis. An excess of body fat is also associated with many changes in the metabolic function of the gut and increased intestinal inflammation. Tirzepatide, a type of incretin mimetic or glucagon-like peptide 1 medication, is a weight loss drug which helps lower blood sugar and support weight loss by mimicking natural hormones that regulate insulin. Tirzepatide may reduce risk factors, including weight loss, and prevent the development of early-onset CRC in patients with a recent diagnosis of colorectal adenoma. Studying samples of blood, urine, stool and saliva in the laboratory from patients receiving tirzepatide may help doctors learn more about the effects of tirzepatide on the molecules (biomarkers) related to CRC. It may also help predict a person's future risk of developing CRC.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07095517.
Locations matching your search criteria
United States
Massachusetts
Boston
Massachusetts General Hospital Cancer CenterStatus: Active
Contact: Andrew T Chan
Phone: 617-726-3212
Dana-Farber Cancer InstituteStatus: Active
Contact: Andrew T Chan
Phone: 617-726-3212
Cambridge
Massachusetts Institute of TechnologyStatus: Active
Contact: Andrew T Chan
Phone: 617-726-3212
PRIMARY OBJECTIVE:
I. To determine the effect of tirzepatide intervention urinary prostaglandin metabolites (PGE-M), an established CRC risk biomarker, in context of changes in body weight.
SECONDARY/EXPLORATORY OBJECTIVES:
I. To measure the effect of tirzepatide intervention on the following CRC-associated biomarkers in context of changes in body weight:
Ia. Inflammatory transcriptional signatures (single-cell ribonucleic acid sequencing [scRNA-seq]);
Ib. Plasma proteomic and metabolomic biomarkers associated with CRC;
Ic. Bacterial populations and products associated with colorectal cancer in saliva and stool (metagenomics/metabolomics).
OUTLINE:
Patients receive tirzepatide subcutaneously (SC) once weekly (QW) for up to 24 weeks in the absence of unacceptable toxicity. Patients also undergo urine, blood, and saliva/oral swab sample collection and flexible sigmoidoscopy with mucosal biopsy throughout the study.
After completion of study intervention, patients are followed up 1-2 times annually for up to 3 years.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorAndrew T Chan
