Phase 1 Study of Weekly Tirzepatide Injections to Prevent Early-Onset Colorectal Cancer Evaluating Effects on Biomarkers in Adults 18 to 50 Years Old with Colorectal Adenomas

What this Trial Is About

Researchers are investigating the effects of tirzepatide, an incretin mimetic drug commonly used to manage diabetes and obesity, on biomarkers linked to colorectal cancer risk. This Phase 1 exploratory trial focuses on patients recently diagnosed with adenoma, a type of intestinal polyp that can lead to colorectal cancer. The study aims to understand how tirzepatide might prevent colorectal cancer and to explore a precision prevention approach for future larger studies. Participants will receive weekly injections of tirzepatide for up to 24 weeks, starting at 2.5 mg per week with dose increases every 4 weeks until reaching 15 mg or the highest tolerable dose. The treatment includes four clinical visits an initial visit before starting the drug, a Week 1 visit, a midpoint visit around 9 to 12 weeks, and a final visit after completion. During the initial and final visits, participants undergo flexible sigmoidoscopy and provide various biological samples. The Week 1 and midpoint visits involve additional sample collections and body measurements. Throughout the study, researchers will collect stool, urine, blood, saliva, and tissue biopsy samples to measure changes in biomarkers related to colorectal cancer risk. Participants will be closely monitored weekly for adherence and safety. The primary outcome is the change in urinary PGE-M levels from enrollment to the end of treatment at 24 weeks. Secondary outcomes include changes in plasma GDF-15. The total expected participation duration is about 24 weeks, with a possible short extension if necessary.

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