RecruitingPhase 2NCT07107334

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

A Pilot Study to Estimate Early Clinical Efficacy Signals of a Glucagon-like Peptide 1 Receptor Agonist (GLP-1RA) Administration in Conjunction With Levonorgestrel Intrauterine Device (LNG-IUD) in Obese Patients With Endometrioid Intraepithelial Neoplasia


Sponsor

University of Florida

Enrollment

20 participants

Start Date

Apr 7, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a GLP-1 agonist (a hormone-based medication similar to drugs like semaglutide, often used for diabetes and weight loss) to a hormonal IUD (levonorgestrel) can help treat early-stage uterine cancer or pre-cancerous uterine changes in obese women who want to avoid surgery. **You may be eligible if:** - You are 18 or older - You have been diagnosed in the last 3 months with grade 1 endometrial (uterine) adenocarcinoma or pre-cancerous uterine changes (endometrial intraepithelial neoplasia) - Your cancer has not spread beyond the uterus (confirmed by MRI or ultrasound) - Your BMI is 30 or higher - You have obesity-related health conditions such as high blood pressure, diabetes, or sleep apnea **You may NOT be eligible if:** - Your cancer has spread outside the uterus or into the uterine muscle - You are not obese (BMI under 30) - You have conditions that make this treatment unsafe (e.g., history of pancreatitis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGlucagon-like peptide 1 receptor agonist

Subjects will receive a glucagon-like peptide 1 receptor agonist (either semaglutide, tirzepatide or liraglutide) by self-injection or orally (for semaglutide only) for as clinically indicated by the treating physician or until the subject receives clearance for staging hysterectomy or for pregnancy pursuit. The choice of glucagon-like peptide 1 receptor agonist for each subject will be at the treating physician's discretion. Subjects will discontinue the glucagon-like peptide 1 receptor agonist 2 weeks before any elective surgical procedure.


Locations(1)

University of Florida

Gainesville, Florida, United States

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NCT07107334


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