RecruitingEarly Phase 1NCT07065552

Tirzepatide in Obesity-Driven Endometrial Cancer

A Pre-Operative Window Study of Tirzepatide in Obesity-Driven Endometrial Cancer

Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

20 participants

Start Date

Apr 27, 2026

Study Type

INTERVENTIONAL

Conditions

Endometrial Cancer Obesity

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

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 Criteria8

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.

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Interventions

DRUGTirzepatide

Tirzepatide will be administered once weekly, subcutaneously, and patients will be taught how to administer this drug at home. Patients will be started on a dose of 5 mg tirzepatide weekly for four weeks prior to surgical staging. .