Recruiting
Phase 1

Tirzepatide

Sponsor:

Massachusetts General Hospital

Code:

NCT07095517

Conditions

Colorectal Cancer Prevention

Colorectal Adenoma

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Study Details

Brief summary:

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.

Conditions

Colorectal Cancer Prevention

Colorectal Adenoma

Study ID

NCT07095517

Start date

Feb 24, 2026

Status verified date

Feb, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Tirzepatide

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.

Interventions

Tirzepatide

Study drug injected subcutaneously once a week

Primary outcome measure

  • Change in Urinary PGE-M [ Time Frame: From enrollment to the end of treatment at 24 weeks ]

Central Contacts and Locations

Central contacts

Andrew T. Chan, MD, MPH

617-726-3212achan@mgh.harvard.edu

Locations

Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Andrew T. Chan, MD, MPH

617-726-3212achan@mgh.harvard.edu

Principal Investigator:

Andrew T. Chan, MD, MPH

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • colorectal cancer
  • colorectal cancer prevention
  • colorectal adenoma
  • obesity
  • incretin mimetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-02-27.