RightFit
RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 1 visit
  • Time periods mentioned: 24 weeks
  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will self-administer the second dose of the study drug at the Week 1 visit under supervision of study staff."
  • "At the Week 1 and Midpoint visits, they will also provide body measurements, blood, urine, saliva, and stool samples."
  • "Participants will be instructed to inject tirzepatide 1 time per week for up to 24 weeks."
  • "The dose will start with a 2.5mg injection per week for the first 4 weeks."
  • "Dose will increase 2.5mg/injection every 4 weeks until 15mg/injection (or maximum tolerable dose) per week is reached."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small, early study tests how tirzepatide changes signs linked to colon and rectal cancer risk in tissue, urine, blood, and gut microbes. It is for adults ages 18 to under 50 with a BMI of 27–40 who recently had certain colon or rectal growths removed. The study will also help researchers plan a larger prevention study.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 to under 50 when joining.
  • Have a body mass index (BMI), a measure of weight compared with height, of 27–40.
  • Have had a colonoscopy, a test that looks inside the colon and rectum, within the past 9 months.
  • At your last colonoscopy, have had at least 2 adenomas removed, or 1 adenoma at least 6 millimeters wide. These are growths that may turn into cancer. Sessile serrated adenomas count, but hyperplastic polyps do not.
  • Be able to understand and willing to sign a form agreeing to join the study.

Who can't join

  • Have ever taken an incretin mimetic, the type of medicine that includes tirzepatide.
  • Have had medullary thyroid cancer or MEN 2, a condition linked to certain tumors.
  • Have a high risk of pancreatitis (swelling of the pancreas), or another reason the drug label says you should not take tirzepatide.
  • Have had cancer in the past 3 years, except non-melanoma skin cancer.
  • Have ever had diabetes or bowel surgery.
  • Have an inherited cancer condition, such as Lynch syndrome or familial adenomatous polyposis.
  • Have had inflammatory bowel disease, Crohn’s disease, or colitis, which cause swelling in the bowel.
  • Are pregnant, or had a growth that was not fully removed during your last colonoscopy.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

MA