NCT07095517RecruitingPhase 1
Pathways, Risk Factors, and mOleculeS to Prevent Early-onset Colorectal Tumors
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 24 Jul 2025
- Start date
- 24 Feb 2026
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Obesity, Colorectal cancer
- NCT number
- NCT07095517
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 24 Feb 2026 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have ever taken incretin mimetic therapies.
- Participants with incomplete or partial polypectomy during prior colonoscopy.
Other illness
- Participants with a history of medullary thyroid cancer or MEN 2 syndrome.
- 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.
Other
- Participants at high risk of pancreatitis or otherwise contraindicated for use of tirzepatide according to clinical labeling.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Cancer Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.