Could a Weight-Loss drug stop colon cancer before it starts?
NCT ID NCT07095517
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests whether tirzepatide, a drug used for diabetes and weight loss, can lower biological markers linked to colorectal cancer risk. Researchers will enroll 20 adults aged 18-50 with a BMI between 27 and 40 who have had a recent colonoscopy. The goal is to see if the drug changes certain substances in urine, blood, and tissue that are associated with cancer development.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Massachusetts General Hospital Cancer Center
RECRUITINGBoston, Massachusetts, 02114, United States
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