Tirzepatide for Endometrial Cancer

Overseen By Chelsea Baker

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: UNC Lineberger Comprehensive Cancer Center

Must not be taking: Insulin, Weight-loss drugs

Disqualifiers: Pregnancy, Type 1 diabetes, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the medication tirzepatide can combat early-stage endometrial cancer and its precursors. Researchers believe tirzepatide might slow or stop tumor growth while promoting weight loss, which is crucial since obesity often links to endometrial cancer. Participants will receive tirzepatide or not before their scheduled uterus surgery to assess its effect on cancerous cells. The trial seeks individuals with endometrial intraepithelial neoplasia or early-stage endometrial cancer, who also have a body mass index over 30. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've taken drugs that influence weight change in the past 3 months. It's best to discuss your specific medications with the trial team.

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

Research has shown that tirzepatide is generally safe for humans. Studies have found no increased risk of cancer in those taking it compared to those who are not. This finding is crucial as the treatment is being considered for cancer-related conditions.

In another study, tirzepatide reduced tumor size and slowed cancer cell growth in mice, suggesting it may help fight tumors without causing significant harm to the body.

Some individuals using tirzepatide might experience side effects like changes in blood sugar levels. Patients often use glucose monitors to track their blood sugar, helping to prevent serious issues.

Overall, tirzepatide appears promising for both weight loss and cancer treatment, and current research indicates it is safe. ^{1 2 3 4 5}

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

Tirzepatide is unique because it targets the GLP-1 and GIP receptors, offering a novel mechanism of action compared to traditional treatments for endometrial cancer, which often include surgery, radiation, and chemotherapy. Researchers are excited about tirzepatide because, as a medication initially developed for diabetes and obesity, it has shown potential to affect metabolic pathways that could influence cancer cell growth. This dual-action on metabolic and cancer pathways presents a new avenue for treatment, potentially enhancing outcomes and providing a fresh approach to tackling endometrial cancer.

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

Research has shown that tirzepatide might slow tumor growth in endometrial cancer by affecting metabolism and abnormal cells. In this trial, one arm will receive a 4-week treatment with tirzepatide, which earlier studies found can reduce tumor size by more than 60%. This treatment alters the tumor environment and aids in weight loss, crucial since endometrial cancer often links to obesity. Tirzepatide also influences key biological processes like insulin and fat metabolism, which are frequently disrupted in obesity. Overall, evidence suggests tirzepatide could be a promising option for slowing or stopping the growth of early-stage endometrial cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Victoria Bae-Jump

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for women with obesity who have been diagnosed with endometrial intra-epithelial neoplasia (EIN) or Grade 1 endometrial cancer. Participants should not be receiving other treatments for these conditions.

Inclusion Criteria

I can care for myself but may not be able to do active work.

My BMI is over 30.

My organ functions are within normal ranges as required.

Exclusion Criteria

I have never had severe low blood sugar or can't recognize its symptoms.

Subject is pregnant or breastfeeding, or planning to become pregnant at any time during the study

I have not taken drugs that affect my weight in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tirzepatide or no tirzepatide for 4 weeks prior to hysterectomy surgery

4 weeks

Weekly visits for monitoring and diary completion

Surgery

Participants undergo standard of care hysterectomy surgery 7-10 days after the final dose of tirzepatide

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery and referred to a weight loss clinic

4 weeks

1 visit (in-person) at 1-month post-operation

What Are the Treatments Tested in This Trial?

Interventions

• Tirzepatide

Trial Overview The study tests tirzepatide's effect on the uterus in patients with EIN and early-stage endometrial cancer, comparing biopsy samples before and after treatment to see if it reduces tumor growth.

How Is the Trial Designed?

Group I: tirzepatide Experimental Treatment 1 Intervention

The treatment arm will receive 5mg tirzepatide for 4 weeks prior to standard of care surgery.

Group II: No tirzepatide Active Control 1 Intervention

No tirzepatide arm will not receive tirzepatide, and Standard Operating Procedures will be applied.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

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

Tirzepatide for fertility-sparing treatment in obese/overweight ... Further analysis revealed that tirzepatide effectively alters the host and tumour environment, reducing body weight by modulating glycolysis, ...

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 with tirzepatide for 4 weeks significantly reduced tumor weight by 66.4 % and 60.1 % in the HFD- and LFD-fed groups, respectively (Fig ...

4. 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 ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2416394

Tirzepatide as Compared with Semaglutide for ... Clinically meaningful weight reductions occur with both medications, with reported mean weight reductions of up to 22.9% after nearly 3.5 years ...

6. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2840878?widget=personalizedcontent&previousarticle=2816783

Semaglutide and Tirzepatide Prescribing in Patients With ... The highest prevalent prescription rate was in thyroid cancer (10.1%), followed by breast (7.2%) and endometrial (7.1%) cancers. The lowest ...