Clinical Trial

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

Recruiting Phase 2
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Summary
This study will explore the use of glucagon-like peptide 1 receptor agonist (GLP-1RA) used concurrently with levonorgestrel intrauterine device in patients with poor surgical candidacy for a hysterectomy or patients who are pursuing fertility sparing. GLP-1RA are a class of medications that mimic the natural hormone glucagon-like peptide-1. These medications trigger the pancreas to release insulin which can help lower blood sugar levels and delay gastric emptying. The recent FDA approval of GLP-1RAs has changed the landscape for pharmacotherapy for weight loss. These hormone-based obesity medications are novel and revolutionary in obesity medicine. Liraglutine, semaglutide, and tirzepatide have become exceedingly popular for their effects on weight loss and obesity-related comorbidities. More recently, GLP-1RAs have exhibited risk reduction of various obesity associated cancers, including endometrial cancer but their exact role in prevention and treatment has yet to be measured.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-07-30; most recent amendment 2026-06-04.
Status change: Not Yet Recruiting → Recruiting 2026-02-16
Trial Details
NCT Number NCT07107334
Lead Sponsor University of Florida
Conditions Endometrioid Endometrial Adenocarcinoma
Enrollment 20 participants
Start Date 2026-04-07
Primary Completion 2028-11 (estimated)
Study Completion 2029-11 (estimated)
Updated on ClinicalTrials.gov 2026-06-08