Tirzepatide for Colorectal Cancer

(PROSPECT Trial)

Overseen By Andrew T. Chan, MD, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Massachusetts General Hospital

Must not be taking: Incretin mimetics

Disqualifiers: Thyroid cancer, Pancreatitis, Diabetes, Bowel surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how tirzepatide might reduce the risk of colorectal cancer. Researchers aim to assess the drug's impact on specific markers in the body, such as those in blood and tissue. The trial involves a weekly injection of tirzepatide, with doses gradually increasing over 24 weeks. Individuals who have had multiple or large adenomas removed and have a BMI between 27 and 40 might be suitable candidates. This study serves as a first step in determining if this approach could be effective on a larger scale in the future. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that tirzepatide is likely to be safe for humans?

Research has shown that tirzepatide is generally safe. In studies involving over 10,000 people, no proven link between tirzepatide and cancer in humans has been found, suggesting it likely doesn't increase cancer risk.

In lab studies, tirzepatide effectively stopped colon cancer cells from growing and even helped shrink tumors. While these results are promising, they are early findings. This trial is in Phase 1, focusing primarily on safety. Although tirzepatide is approved for other uses, its safety for treating colorectal cancer remains under investigation.

Participants should consider these points when deciding to join the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about tirzepatide for colorectal cancer because it offers a fresh approach compared to existing treatments like chemotherapy and targeted therapies. Unlike these traditional options, tirzepatide is a peptide-based drug that harnesses the body's own hormonal pathways, specifically targeting the GLP-1 and GIP receptors, which are not typically addressed in standard colorectal cancer treatments. This unique mechanism of action could potentially enhance treatment effectiveness and offer a new avenue for managing the disease, particularly for patients who may not respond well to current therapies. Additionally, its once-weekly injection schedule could improve patient convenience and adherence compared to more frequent treatment regimens.

What evidence suggests that tirzepatide might be an effective treatment for colorectal cancer?

Research shows that tirzepatide might help treat colorectal cancer. In lab studies, tirzepatide stopped colon cancer cells from growing and helped kill them. It also caused tumors to shrink in animal tests. Known for controlling blood sugar and aiding weight loss, tirzepatide's potential to slow cancer growth is under investigation. So far, studies have not found an increased cancer risk with tirzepatide use. These early results suggest tirzepatide might help manage colorectal cancer, but more research is needed to confirm its effectiveness in people. Participants in this trial will receive tirzepatide to further investigate its potential benefits for colorectal cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Andrew T. Chan, MD, MPH

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with obesity who are at risk of developing early-onset colorectal tumors, including colon cancer and colorectal adenomas. Participants should be interested in a study exploring how a medication might influence cancer risk markers.

Inclusion Criteria

Underwent a screening or surveillance colonoscopy within the prior 9 months

My BMI is between 27 and 40.

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Participants with a history of diabetes mellitus

I am at high risk for pancreatitis or cannot use tirzepatide as advised by its label.

I have had surgery on my bowels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive tirzepatide injections weekly, with dose escalation every 4 weeks, for up to 24 weeks

24 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tirzepatide

Trial Overview The trial is testing Tirzepatide, an incretin mimetic drug, to see its effects on various biological markers that could indicate the risk of colorectal cancer. It's an initial phase study aiming to set the stage for larger future trials.

How Is the Trial Designed?

Group I: Tirzepatide Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Cancer Research UK

Collaborator

Trials

262

Recruited

4,435,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12097124/

The Novel Dual GIP and GLP‐1 Receptor Agonist ... TZP significantly inhibited colon cancer cell proliferation promoted apoptosis in vitro and induced durable tumor regression in vivo under ...

2. e-enm.org e-enm.org/journal/view.php?number=2572

Tirzepatide and Cancer Risk in Individuals with and without ... A recent meta-analysis, which included data from 37 RCTs and 19 real-world studies, reported no increased risk of any cancer with semaglutide ...

3. metwarebio.com metwarebio.com/tirzepatide-colorectal-cancer-spatial-metabolomics/

Spatial Metabolomics Reveals How Tirzepatide Inhibits ... While widely recognized for its efficacy in improving glycemic control and weight loss, this study investigates whether TZP could also suppress cancer growth by ...

4. ascopubs.org ascopubs.org/doi/10.1200/OP.2025.21.10_suppl.528

Tirzepatide vs semaglutide for metabolic optimization in ... This study evaluated the comparative effectiveness of tirzepatide vs. semaglutide across weight and metabolic markers in cancer survivors.

5. bmcgastroenterol.biomedcentral.com bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-025-04211-4

Association between GLP-1 receptor agonists as a class and ... The findings of this study suggest complex associations between the use of GLP-1 RAs and colorectal cancer risk. The findings reported an ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11898313/

Tirzepatide and Cancer Risk in Individuals with and without ... Effect of tirzepatide on the primary outcome: risk of any cancer. Overall, tirzepatide use was associated with a similar risk of any cancer to the pooled ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07095517

Pathways, Risk Factors, and mOleculeS to Prevent Early- ... Tirzepatide may prevent colorectal cancer through multiple possible biological mechanisms. This includes weight loss which can reduce the risk of developing ...

8. fellahealth.com fellahealth.com/guide/is-tirzepatide-linked-to-cancer

Is Tirzepatide Linked to Cancer? FDA Safety Data and ... As of 2024, no established causal link exists between tirzepatide and cancer development in humans. Clinical trials involving over 10,000 participants showed no ...

9. pdfs.semanticscholar.org pdfs.semanticscholar.org/9fcc/c48138cc3b2a45199aca7f1ac2a295d837e0.pdf

Tirzepatide and Cancer Risk in Individuals with and without ... The primary outcome was the overall risk of any cancer, and secondary out- comes were the risks of specific types of cancer in the tirzepatide versus the ...