Tirzepatide in the Treatment of Endometrial Cancer

What this study is testing ClinicalTrials.gov NCT07605247 ↗

Description as written by the study sponsor.

This study is looking for a better way to treat pre-cancer or early-stage cancer in the lining of the uterus in women who are also overweight. Everyone in the study will receive the standard treatment, a Progesterone IUD (LNG-IUD). This device is put in the uterus and releases hormones to help fight the disease. We will add a new medicine, Tirzepatide, for some people. Tirzepatide is a shot that helps with weight loss and overall health. You will be placed into one of two groups by chance (like flipping a coin): 1. Group 1: You get the Progesterone IUD PLUS the Tirzepatide shot. 2. Group 2: You get the Progesterone IUD ONLY (Standard Treatment). During the study, you will be asked to fill out surveys often. These questions ask about your daily life, how you feel about your health and weight, and any side effects you might have. This helps us understand how the treatments affect you. You will have small tissue samples (biopsies) taken from your uterus at different times. This is how doctors check at 12 months (one year) if the pre-cancer or cancer cells are completely gone. The schedules for visits, tests, and monitoring will be identical for both groups to ensure fairness. If this study is successful, it could mean that women who are overweight with these conditions can get a better treatment that gets rid of the disease and still allows them to keep their ability to have children (avoids surgery). It may also improve their overall health through weight loss.

Treatments tested

• Tirzepatide Drug

  Phase I (Months 0-3): All participants receive LNG-IUD alone

• LNG-IUD plus tirzepatide Device

  Phase II (Months 3-9): All participants continue LNG-IUD plus tirzepatide (titrated to maximally tolerated dose).