Colorectal Cancer PreventionPhase 1PROSPECTNCT07095517
Pathways, Risk Factors, and mOleculeS to Prevent Early-onset Colorectal Tumors
A Phase 1 study testing Tirzepatide in people with Colorectal Cancer Prevention and Colorectal Adenoma, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Colorectal Cancer Prevention, Colorectal Adenoma
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2026to 31 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Andrew T. Chan, MD, MPH, 617-726-3212, achan@mgh.harvard.edu
Andrew T. Chan, MD, MPH
About this 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.
Read the detailed description
In this research study, we are:
- Investigating the effects of tirzepatide on biomarkers of colorectal cancer risk in patients with a recent diagnosis of adenoma, a type of intestinal polyp that can precede the development of cancer.
- Planning to measure the potential protective effects associated with tirzepatide within biological samples (biospecimens) including stool, urine, blood, and oral swab samples collected prior to, during, and after treatment with tirzepatide.
- Tirzepatide is a part of the incretin mimetic (GLP-1 receptor agonist) family, which are typically used for managing diabetes and/or obesity.
- Tirzepatide may prevent colorectal cancer through multiple possible biological mechanisms. This includes weight loss which can reduce the risk of developing obesity-associated cancers, such as colorectal cancer.
- Tirzepatide has been shown to effectively induce weight loss and improve glycemic control.
The exact mechanism by which tirzepatide acts to prevent colorectal cancer is still unknown. By performing this research study, we will study the mechanisms of its anti-cancer effect, which may lead to the discovery of novel specific characteristics (markers) that can be used to select patients for tirzepatide treatment to reduce risk of cancer in the future.
The research procedures include screening for eligibility and study treatment and scheduling four clinical research visits:
- Initial visit - immediately before starting the study drug
- Week 1 visit
- Midpoint visit (9-12 weeks later) (Midpoint visit)
- Final visit (after completing the drug intervention)
At the Initial and Final visits, a flexible sigmoidoscopy will be performed along with the collection of body measurements, questionnaire data, blood, urine, saliva, stool, and up to 24 tissue biopsy samples. The first dose of the study drug will be administered by study staff at the initial visit. 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. 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.
It is expected that about 20 people will take part in this research study.
This research is being supported by The Cancer Grand Challenges partnership funded by Cancer Research UK, the National Cancer Institute, the Bowelbabe Fund for Cancer Research UK and Institut National Du Cancer.
- Conditions
- Colorectal Cancer Prevention, Colorectal Adenoma
- Being tested
- Tirzepatide
- Keywords
- colorectal cancer, colorectal cancer prevention, colorectal adenoma, obesity, incretin mimetics
- Medical subject headings
- Colorectal Neoplasms, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called Zepbound
Study drug injected subcutaneously once a week
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Experimental | 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. Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urinary PGE-M
To determine the effect of tirzepatide intervention on urinary prostaglandin metabolites (PGE-M), an established CRC risk biomarker, in context of changes in body weight.
Measured: From enrollment to the end of treatment at 24 weeks
Secondary outcomes (1)
Change in Plasma GDF-15
Comparing change in GDF-15 in pre- and post-treatment plasma
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start24 Feb 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer PreventionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Cancer Research UK
- Responsible party
- Principal investigator, Andrew T. Chan, MD, MPH, Massachusetts General Hospital
- Investigators
- Andrew T. Chan, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095517
- Sponsor's protocol ID
- 25-460
- Other IDs
- 1OT2CA297680-01, CGCATF-2023/100036
- Acronym
- PROSPECT
- Status last verified
- Feb 2026
- First submitted
- 24 Jul 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Andrew T. Chan, MD, MPH. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathways, Risk Factors, and mOleculeS to Prevent Early-onset Colorectal Tumors
- ClinicalTrials.gov ID
- NCT07095517
- Acronym / sponsor ID
- PROSPECT / 25-460
- Conditions
- Colorectal Cancer Prevention, Colorectal Adenoma
- Keywords
- colorectal cancer, colorectal cancer prevention, colorectal adenoma, obesity, incretin mimetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Cancer Research UK
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this research study, we are:
- Investigating the effects of tirzepatide on biomarkers of colorectal cancer risk in patients with a recent diagnosis of adenoma, a type of intestinal polyp that can precede the development of cancer.
- Planning to measure the potential protective effects associated with tirzepatide within biological samples (biospecimens) including stool, urine, blood, and oral swab samples collected prior to, during, and after treatment with tirzepatide.
- Tirzepatide is a part of the incretin mimetic (GLP-1 receptor agonist) family, which are typically used for managing diabetes and/or obesity.
- Tirzepatide may prevent colorectal cancer through multiple possible biological mechanisms. This includes weight loss which can reduce the risk of developing obesity-associated cancers, such as colorectal cancer.
- Tirzepatide has been shown to effectively induce weight loss and improve glycemic control.
The exact mechanism by which tirzepatide acts to prevent colorectal cancer is still unknown. By performing this research study, we will study the mechanisms of its anti-cancer effect, which may lead to the discovery of novel specific characteristics (markers) that can be used to select patients for tirzepatide treatment to reduce risk of cancer in the future.
The research procedures include screening for eligibility and study treatment and scheduling four clinical research visits:
- Initial visit - immediately before starting the study drug
- Week 1 visit
- Midpoint visit (9-12 weeks later) (Midpoint visit)
- Final visit (after completing the drug intervention)
At the Initial and Final visits, a flexible sigmoidoscopy will be performed along with the collection of body measurements, questionnaire data, blood, urine, saliva, stool, and up to 24 tissue biopsy samples. The first dose of the study drug will be administered by study staff at the initial visit. 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. 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.
It is expected that about 20 people will take part in this research study.
This research is being supported by The Cancer Grand Challenges partnership funded by Cancer Research UK, the National Cancer Institute, the Bowelbabe Fund for Cancer Research UK and Institut National Du Cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | Experimental | Drug: TirzepatideParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: ZepboundStudy drug injected subcutaneously once a week | Drug | Tirzepatide |
Primary outcome
Change in Urinary PGE-M
Time frame: From enrollment to the end of treatment at 24 weeks
To determine the effect of tirzepatide intervention on urinary prostaglandin metabolites (PGE-M), an established CRC risk biomarker, in context of changes in body weight.
1 secondary outcome
Change in Plasma GDF-15
Time frame: From enrollment to the end of treatment at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Andrew T. Chan, MD, MPH. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew T. Chan, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tirzepatide in people with Colorectal Cancer Prevention and Colorectal Adenoma, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew T. Chan, MD, MPH (617-726-3212, achan@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Urinary PGE-M (time frame: From enrollment to the end of treatment at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.