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Tirzepatide for Endometrial Cancer and Obesity

This study is looking at how a drug called tirzepatide affects endometrial cancer (cancer of the lining of the uterus) in women who also have obesity. Researchers want to see if tirzepatide can slow down the growth of cancer cells before surgery. You would receive tirzepatide once a week for four weeks before your scheduled hysterectomy (surgery to remove the uterus). The study will compare tissue samples taken before and after treatment to see if the cancer cells have changed. This study is for women aged 18 or older who have a specific type of endometrial cancer and are scheduled for a hysterectomy. The goal is to enroll 20 participants.

Study design
This is an interventional study with 20 participants. It is a pre-operative window study, meaning treatment happens before surgery.
What's involved
You would receive tirzepatide once weekly for four weeks at home, with training provided. There will be a single end-of-treatment visit four weeks after completing therapy.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months after treatment to monitor weight loss maintenance.

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NCT07065552

Tirzepatide in Obesity-Driven Endometrial Cancer

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
UNC Lineberger Comprehensive Cancer Center
~20 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:Tirzepatide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Proliferation
Measured over Baseline - Up to 6 weeks

Conditions

Endometrial Cancer
Obesity

Explore related trials

Endometrial Carcinoma

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Bae-Jump Victoria, MD PhD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center

Who to contact

Luz Cuaboy
[email protected]
+1 919-966-4432
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Current diagnosis of endometrioid histology cancer and scheduled to undergo hysterectomy and staging.
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.
Age ≥ 18 at the time of consent.
Body mass index of ≥30 kg/m2.
Presumed clinically early-stage disease (disease confined to uterus only).
ECOG ≤ 2 or Karnofsky Performance Status of \> 50

Exclusion

Active infection requiring systemic therapy.
Subject is pregnant or breast feeding.
Taking any prescription medications or other drugs that may influence metabolism per discretion of investigator.
Taking a central nervous system stimulant.
Current psychological conditions that would be incompatible with participation in this study, as determined by investigator.
Known sensitivities (i.e., urticaria and eczema) to GIP and GLP-1 receptor agonists.
Have type 1 diabetes mellitus or latent autoimmune diabetes in adults or receiving treatment with insulin.
Have a history of severe hypoglycemia or not be able to communicate an understanding of hypoglycemic symptoms.

What this trial measures

  • Change in ProliferationBaseline - Up to 6 weeks

    Change in Proliferation will be determined by immunohistochemical ( Ki-67 staining) analysis pre- (baseline) and post-tirzepatide treatment hysterectomy samples (at the time of surgery and end of treatment). The percentage of tumor cells that are positive for Ki-67, indicating they are in the active phases of the cell cycle (not resting). Low Ki-67 (\<10-15%): Slower-growing tumor. Intermediate (15-30%): Moderately proliferative. High (\>30%): Fast-growing, potentially more aggressive.