Tirzepatide in Women With Obesity and Endometrial Intra-epithelial Neoplasia or Grade 1 Endometrial Cancer

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07078838
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Endometrial Cancer
  • Endometrial Intraepithelial Neoplasia
  • Grade 1 Endometrial Endometrioid Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Patients will receive a subcutaneous dose of 5 mg weekly for the 4 weeks prior to surgical staging.

Study Details

The goal of this study is to determine the anti-proliferative effect of tirzepatide on the endometrium of patients with endometrial intra-epithelial neoplasia (EIN) and Grade 1 endometrial cancer (EC), by comparing archival endometrial biopsy samples of patients randomized to tirzepatide versus SOC (no tirzepatide) to their post-intervention hysterectomy specimens. It was hypothesized that tirzepatide may help fight tumors in two ways: indirectly, by improving the body's overall metabolic health, and directly, by acting on abnormal cells in the uterus, such as those found in endometrial intraepithelial neoplasia (EIN) and endometrial cancer (EC). EIN is considered a precursor to EC. Tirzepatide may influence the tumor environment through key biological pathways related to insulin, fat metabolism, and mTOR signaling, all of which are often disrupted in individuals with obesity. Because both EIN and EC are strongly linked to obesity, tirzepatide could offer a promising dual benefit, promoting weight loss while also slowing or stopping tumor growth. The primary goal of this study is to determine whether tirzepatide can reduce cell proliferation in the lesions or tumors of patients with EIN and early- stage (Grade 1) EC. Patients will either be randomized to receive tirzepatide or no tirzepatide for 4 weeks prior to their hysterectomy surgery. Patients randomized to the tirzepatide arm will be given a glucose monitoring system for continuous monitoring with real-time alarms to alert of hypoglycemia. Patients will complete diaries during treatment to document compliance with medication and record any side effects. Patients will undergo standard of care surgery 7-10 days after the final dose of tirzepatide in order to minimize the risk of gastroparesis. During surgery (hysterectomy), an endometrial biopsy for uterine biopsy tissue will be collected. At the 1-month post-operation visit, patients from both arms will be referred to an institutional weight loss clinic.

Key Dates

Start date
Aug 31, 2026
Status verified
May 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: tirzepatide
    The treatment arm will receive 5mg tirzepatide for 4 weeks prior to standard of care surgery.
  • No Intervention: No tirzepatide
    No tirzepatide arm will not receive tirzepatide, and Standard Operating Procedures will be applied.

Primary Outcome Measure

Anti-proliferative effect of Tirzepatide [ Time Frame: At 4th week (during surgery) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-

Find similar trials in Chapel Hill, NC

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Lineberger Comprehensive Cancer Center· Chapel Hill, NC

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