Study on Tirzepatide for Women with Obesity and Early-Stage Endometrial Conditions

Sponsor: UNC Lineberger Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07078838

Provider View

This clinical trial is exploring whether the medication tirzepatide can help reduce tumor growth in women with obesity who have early-stage endometrial conditions, such as endometrial intra-epithelial neoplasia (EIN) or Grade 1 endometrial cancer (EC).

Patient Parameters

Program Overview

The study aims to find out if tirzepatide can slow down or stop the growth of abnormal cells in the uterus in women with obesity who have early-stage endometrial conditions. Tirzepatide may help by improving overall metabolic health and directly affecting the abnormal cells. Participants will be randomly assigned to receive tirzepatide or not before their scheduled surgery to remove the uterus (hysterectomy). Those receiving tirzepatide will also use a glucose monitor to track blood sugar levels and keep a diary of any side effects. After surgery, all participants will be referred to a weight loss clinic to support their health.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate and allow access to personal health information.
  • Willing and able to follow study procedures.
  • Age over 18 years.
  • Good general health with a performance status score of 2 or less.
  • Diagnosed with endometrial intraepithelial neoplasia (EIN) or Grade 1 endometrial cancer (EC) and scheduled for hysterectomy.
  • Must have previous tissue samples available for review.
  • Body mass index (BMI) over 30.
  • Must have adequate organ function as shown by recent lab tests.

Exclusion Criteria

  • Have an active infection needing treatment.
  • Pregnant, breastfeeding, or planning to become pregnant during the study.
  • Taking medications that affect weight in the last 3 months.
  • Allergic to certain diabetes medications.
  • Have type 1 diabetes or are on insulin.
  • History of severe low blood sugar or cannot recognize its symptoms.
  • History of pancreatitis or high levels of certain enzymes or fats in the blood.
  • Have stomach issues like gastroparesis or have had weight loss surgery.
  • Family history of certain thyroid or endocrine cancers.
  • Currently receiving other treatments for EIN or EC.
  • Any condition that the study doctor believes would make participation unsafe.

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