Who is eligible for clinical trial NCT07065552?

Participants must meet protocol criteria for Endometrial Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07065552 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-27

Tirzepatide in Obesity-Driven Endometrial Cancer (NCT07065552)

🟢 Recruiting Early Phase1 💊 Investigational Drug / Biologic Sponsor: UNC Lineberger Comprehensive Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (9 items).

Location: Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗