Pilot Study of GLP-1 Receptor Agonist with Levonorgestrel IUD in Obese Women with Early Endometrioid Endometrial Cancer or Intraepithelial Neoplasia

What this Trial Is About

The trial investigates the combined use of glucagon-like peptide 1 receptor agonists GLP-1RA with a levonorgestrel intrauterine device in obese patients diagnosed with endometrioid intraepithelial neoplasia or grade 1 endometrial adenocarcinoma. It focuses on patients who are either poor candidates for hysterectomy surgery or wish to preserve fertility. GLP-1RAs are medications that mimic a natural hormone to help control blood sugar and have recently been approved for weight loss, with potential effects on obesity-related cancers, including endometrial cancer, that are still being studied. Participants will receive one of several GLP-1RA medications, such as semaglutide, tirzepatide, or liraglutide, either by self-injection or orally, as chosen by their treating physician. This treatment continues until they are cleared for either hysterectomy staging surgery or to pursue pregnancy. The levonorgestrel intrauterine device is used concurrently. Subjects will stop the GLP-1RA two weeks before any planned surgery. The study is a phase 2 interventional trial sponsored by the University of Florida. During the study, researchers will monitor the time until participants are cleared for surgery or pregnancy and assess the endometrial tissue response after 6 and 12 months of treatment. They will also track surgical details, hospital stay length, postoperative complications, and patient-reported quality of life at several time points. The total participation duration is up to 12 months, with various evaluations, imaging, and pathology reviews to assess the treatment effects and safety.

A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia