Recruiting
Early Phase 1

Tirzepatide

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT07065552

Conditions

Endometrial Cancer

Obesity

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Study Details

Brief 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.

Conditions

Endometrial Cancer

Obesity

Study ID

NCT07065552

Start date

Apr 27, 2026

Status verified date

Apr, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: endometrial carcinoma

Obese women with endometrial carcinoma are included.

Interventions

Tirzepatide

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. .

Primary outcome measure

  • Change in Proliferation [ Time Frame: Baseline - Up to 6 weeks ]

Central Contacts and Locations

Central contacts

Luz Cuaboy

+1 919-966-4432luz_cuaboy@med.unc.edu

Emmie Cole

+1 919-966-4432emmie_cole@med.unc.edu

Locations

Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Victoria Bae-Jump, M.D., PhD

919-966-5996victoria_baejump@med.unc.edu

Principal Investigator:

Victoria Bae-Jump, M.D., PhD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

  • tirzepatide
  • tumor microenvironment
  • insulin
  • lipid
  • mTOR signaling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-04-28.