Tirzepatide in Obesity-Driven Endometrial Cancer
Recruiting · NCT07065552 · Interventional (participants receive a specific treatment) · Lead sponsor: UNC Lineberger Comprehensive Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed across 1 US state.
- Lineberger Comprehensive Cancer Center - Chapel Hill, North Carolina, United States