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Taking people in United StatesEarly phase 1

Tirzepatide Before Surgery in Obesity-Linked Endometrial Cancer

Tests tirzepatide before surgery in adults with endometrial cancer and obesity.

Plain-language title generated from the registry record
Registry title: Tirzepatide in Obesity-Driven Endometrial Cancer

Key facts

Where
Chapel Hill, United StatesSee the site
Phase
Early phase 1

Where in United States

  • Lineberger Comprehensive Cancer CenterChapel Hill, United StatesTaking people

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Trial details

Who runs it
UNC Lineberger Comprehensive Cancer Center
Trial code
NCT07065552
Record updated
2 October 2026
Original description
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.Read full original descriptionShow less

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

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.

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

ClinicalTrials.gov NCT07065552