Tirzepatide for obesity-related endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pre-operative window study in which 20 obese women with presumed early-stage endometrioid endometrial cancer will receive tirzepatide for four weeks prior to their scheduled hysterectomy. Each patient's diagnostic endometrial biopsy (or archival tissue) will be compared to the hysterectomy specimen to measure changes in tumor proliferation and tumor microenvironment markers. The trial examines both indirect metabolic effects (weight loss, insulin and lipid changes) and possible direct effects on mTOR and related signaling within tumor tissue. Subjects will have an end-of-treatment visit and will be followed via medical record abstraction for 24 months to monitor weight maintenance.

Why it matters

Who can join: the full rules

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's running

• Lineberger Comprehensive Cancer Center
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Bae-Jump Victoria, MD PhD — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Luz Cuaboy
• Email: luz_cuaboy@med.unc.edu
• Phone: +1 919-966-4432

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.