drugset / Trial / NCT07107334

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

NCT07107334

Phase 2 Recruiting 20 enrolled University of Florida
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-04-07
Primary completion
2028-11
Completion
2029-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Liraglutide Peptide Other
Subject Orforglipron Small molecule Oral
Subject Semaglutide Peptide Other
Subject Tirzepatide Peptide Other