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New treatment option for Colorectal Cancer Prevention
Official title Pathways, Risk Factors, and mOleculeS to Prevent Early-onset Colorectal Tumors
ClinicalTrials.gov ID: NCT07095517
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for colorectal cancer prevention.
Also referred to as Zepbound.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 24 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- 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...
- 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...
- Ability to understand and the willingness to sign a written informed consent document.
You likely can't join if
- 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
See the full eligibility 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...
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.