Actively Recruiting

Early Phase 1
Age: 18Years +
FEMALE
NCT07065552

Tirzepatide in Obesity-Driven Endometrial Cancer

Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-04-28

20

Participants Needed

1

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

LCCC2415 examines the antiproliferative effect of tirzepatide on the endometrium of endometrial cancer (EC). This is a pre-operative window clinical study. Endometrial biopsy samples from patients before tirzepatide treatment will be compared to their post-intervention hysterectomy specimens. If archival tissue is unavailable, a fresh biopsy will be taken before tirzepatide treatment. Post-intervention tissue will be collected from the hysterectomy specimen. The hypothesis is that tirzepatide's anti-tumorigenic effects are due to both an improvement in the host's metabolic milieu (indirect effect) and a direct effect on the EC tumor microenvironment via the inter-related pathways of insulin, lipid, and mTOR signaling. Therefore, tirzepatide may be an innovative approach to effectively induce weight loss and inhibit tumor growth in EC, the most obesity-driven of all cancers.

CONDITIONS

Official Title

Tirzepatide in Obesity-Driven Endometrial Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 65 18 at the time of consent.
  • Body mass index of 65 30 kg/m2.
  • Presumed clinically early-stage disease (disease confined to uterus only).
  • ECOG 64 2 or Karnofsky Performance Status of > 50
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

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Research Team

L

Luz Cuaboy

CONTACT

E

Emmie Cole

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Tirzepatide in Obesity-Driven Endometrial Cancer | DecenTrialz