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

What Was Tested

In this phase 1 trial, researchers set out to test Tirzepatide.

It had 1 arm (groups): Tirzepatide (experimental).

The registry classes the interventions as drug.

More on the Plan

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.

Participants will be followed weekly during this time.

In the very rare occasion that there are unavoidable issues scheduling the final visit, treatment may be extended up to an additional 4 weeks.

Who Took Part

20 planned participants were the target.

It was open to people of any sex aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: participants who have ever taken incretin mimetic therapies; participants at high risk of pancreatitis or otherwise contraindicated for use of tirzepatide according to clinical labeling; participants with a history of diabetes mellitus.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Tirzepatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-02-24 with completion listed for 2027-03-31.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Change in Urinary PGE-M (time frame: From enrollment to the end of treatment at 24 weeks).

It also tracked 1 secondary outcome, for example Change in Plasma GDF-15.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Tirzepatide in 20 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.