Tirzepatide for Endometrial Cancer

Overseen By Tamara Pfeffer

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: UNC Lineberger Comprehensive Cancer Center

Must not be taking: Metabolism drugs, CNS stimulants

Disqualifiers: Infection, Pregnancy, Psychological conditions, Diabetes, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how tirzepatide might treat endometrial cancer, which begins in the lining of the uterus. Researchers aim to determine if tirzepatide can aid in weight loss and slow tumor growth. The study compares tissue samples from before and after treatment. Eligible participants have early-stage endometrial cancer, a high body mass index (BMI over 30), and plan to undergo surgery to remove the uterus. As an Early Phase 1 trial, this research seeks to understand how tirzepatide works in people, offering participants a chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking any prescription medications or other drugs that may influence metabolism, as determined by the investigator. It's best to discuss your current medications with the study team to see if they need to be stopped.

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

In earlier studies, tirzepatide has shown promise in treating conditions related to obesity. Research suggests it can help reduce body weight and alter the tumor environment in people with endometrial cancer, often linked to obesity.

Tirzepatide is generally well-tolerated, with studies indicating that the risk of developing cancer is similar to those not taking it. This suggests that using tirzepatide does not significantly increase cancer risk. Some animal studies found that tirzepatide reduced both weight and tumor growth, highlighting its potential benefits.

While detailed safety information for humans in this specific context might be limited, tirzepatide is already approved for other uses, such as treating diabetes, indicating that its safety is fairly well understood. Prospective trial participants might find this background reassuring regarding the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for endometrial cancer?

Most treatments for endometrial cancer involve surgery, radiation, and chemotherapy, which primarily focus on removing or destroying cancer cells. However, Tirzepatide is unique because it targets weight loss and metabolic pathways, which could be particularly beneficial for obese women with endometrial carcinoma. Researchers are excited about Tirzepatide because it combines the action of two hormones, GLP-1 and GIP, which can help improve insulin sensitivity and promote weight loss. This dual-action mechanism not only has the potential to address cancer growth but also tackles obesity, a significant risk factor for endometrial cancer, offering a more comprehensive approach to managing the disease.

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

Research has shown that tirzepatide may help treat endometrial cancer, particularly in obese patients. In studies with mice, tirzepatide treatment resulted in smaller tumors and reduced levels of proteins that promote cancer growth. This suggests the drug might slow tumor growth in endometrial cancer. Tirzepatide improves energy processing in the body and directly affects the cancer area, possibly through pathways related to insulin and fat. While research in humans continues, these early results offer promise for those considering participation in this clinical trial, where tirzepatide is being studied as a treatment for endometrial carcinoma. ^{1 2 4 5 6}

Who Is on the Research Team?

Bae-Jump Victoria, MD PhD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with obesity-driven endometrial cancer, who may also have insulin resistance. Participants will undergo a pre-operative study where their tissue samples before and after tirzepatide treatment are compared.

Inclusion Criteria

Agree to comply with all required study assessments and visits including internet capabilities

Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information

I have endometrioid cancer and will have surgery to remove my uterus.

Exclusion Criteria

I have had severe low blood sugar or can't recognize its symptoms.

Subject is pregnant or breast feeding

Current psychological conditions that would be incompatible with participation in this study, as determined by investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Window Treatment

Participants receive tirzepatide treatment for 4 weeks prior to standard-of-care surgery

4 weeks

1 visit (in-person) for end-of-treatment assessment

Surgery

Participants undergo standard-of-care surgery, and post-treatment hysterectomy specimens are collected

Follow-up

Participants are monitored for weight loss maintenance and other health parameters via medical record abstraction

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Tirzepatide

Trial Overview The study tests the effects of tirzepatide on endometrial cancer by examining changes in tumor cells before and after treatment. It explores how this drug might help with weight loss and inhibit tumor growth through metabolic and direct tumor pathways.

How Is the Trial Designed?

Group I: endometrial carcinoma Experimental Treatment 1 Intervention

Obese women with endometrial carcinoma are included.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12593436/

Tirzepatide for fertility-sparing treatment in obese/overweight ... This study is designed to investigate the therapeutic potential of tirzepatide in fertility-preserving management of obesity-associated ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07065552

Tirzepatide in Obesity-Driven Endometrial Cancer The primary objective is to determine if tirzepatide decreases proliferation in the tumors of EC patients. The effect of tirzepatide on the endometrium of 20 ...

3. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(24)01154-5/fulltext

Tirzepatide as an innovative treatment strategy in a pre- ... Treatment of mice with tirzepatide for 4 weeks effectively reduced tumor weight, along with reduced tumoral expression of Ki67, Bcl-xL, and ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-00102

Tirzepatide or Semaglutide for the Treatment of Weight ... Giving tirzepatide or semaglutide may work better at treating patients with endometrial cancer who are obese, overweight, or with or without type 2 diabetes ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/15/11/e105429.share

a phase II single-arm clinical trial protocol Tirzepatide for fertility-sparing treatment in obese/overweight patients with endometrial cancer and atypical hyperplasia: a phase II single-arm clinical ...

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

Tirzepatide and Cancer Risk in Individuals with and without ... Overall, tirzepatide use was associated with a similar risk of any cancer to the pooled control (RR, 0.78; 95% CI, 0.53 to 1.16; I2=0%; P=0.22, ...