Tirzepatide in Obesity-Driven Endometrial Cancer

NCT ID: NCT07065552

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2028-07-31

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.

Detailed Description

The primary objective is to determine if tirzepatide decreases proliferation in the tumors of EC patients. The effect of tirzepatide on the endometrium of 20 obese women with EC will be evaluated by comparing each patient's endometrial biopsy before tirzepatide treatment to their post-treatment hysterectomy specimen, through a pre- operative window study. These women will begin tirzepatide treatment for 4 weeks prior to standard-of-care (SOC) surgery. Subjects will have a single end-of-treatment visit 4 weeks after completing therapy and will be followed for 24 months via medical record abstraction to monitor weight loss maintenance.

Conditions

Endometrial Cancer; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

endometrial carcinoma

Obese women with endometrial carcinoma are included.

Group Type: EXPERIMENTAL

Tirzepatide

Intervention Type: DRUG

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. .

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. .

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bae-Jump Victoria, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Countries

United States

Central Contacts

Luz Cuaboy

Role: CONTACT

luz_cuaboy@med.unc.edu

+1 919-966-4432

Tamara Pfeffer

Role: CONTACT

tamara_pfeffer@med.unc.edu

+1 919-966-4432

Related Links

http://unclineberger.org/patientcare/clinical-trials/clinical-trials

UNC Lineberger Comprehensive Cancer Center Clinical Trials

Other Identifiers

LCCC2415

Identifier Type: -

Identifier Source: org_study_id