Preventing early-onset colorectal tumors with tirzepatide
Pathways, Risk Factors, and mOleculeS to Prevent Early-onset Colorectal Tumors
This trial will test whether the diabetes/weight-loss drug tirzepatide changes tissue, blood, urine, stool, and microbiome markers linked to colorectal cancer risk in adults under 50 who recently had adenomas.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07095517 on ClinicalTrials.gov |
What this trial studies
This is an open-label Phase 1 exploratory pilot that gives tirzepatide to adults aged 18–50 with recent colon adenomas and collects biospecimens before, during, and after treatment. Investigators will measure biomarkers in stool, urine, blood, oral swabs, tissue, and the gut microbiome to look for changes associated with lowered colorectal cancer risk. The goal is to understand biological mechanisms and the feasibility of a precision prevention approach to inform a larger trial. No blinding or placebo is used, and participants must attend four clinical visits at the study site for sample collection and safety monitoring.
Who should consider this trial
Good fit: Adults aged 18–50 with BMI 27–40 kg/m2 who had a screening or surveillance colonoscopy within the prior nine months with removal of at least two adenomas or a single adenoma ≥6 mm and who can consent are ideal candidates.
Not a fit: Patients who have used incretin mimetic therapies before, who have a history of medullary thyroid cancer or MEN2, who are at high risk for pancreatitis, or who fall outside the age/BMI/adenoma criteria are unlikely to benefit from joining this trial.
Why it matters
Potential benefit: If successful, tirzepatide could lower biomarkers linked to colorectal cancer risk and help develop targeted prevention strategies for younger adults with adenomas.
How similar studies have performed: GLP-1 receptor agonists like tirzepatide have reliably produced weight loss and improved glucose control, but their direct effect on colorectal cancer prevention is unproven and this application remains exploratory.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Andrew T. Chan, MD, MPH — Massachusetts General Hospital
- Study coordinator: Andrew T. Chan, MD, MPH
- Email: achan@mgh.harvard.edu
- Phone: 617-726-3212
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.