A Phase 2 interventional study of Glucagon-like peptide 1 receptor agonist in Endometrioid Endometrial Adenocarcinoma, sponsored by University of Florida. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by University of Florida · Phase 2, Interventional, and Treatment
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.
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's planned enrollment of 20 is below the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
BMI ≥ 30 kg/m2 and one of the following (per medical record or self-report):
Exclusion Criteria:
Drug: Glucagon-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 (semaglutide or orforglipron) 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.
Time from start of GLP-1RA to clearance of staging hysterectomy
Determine the time from start of GLP-1RA treatment to clearance for staging hysterectomy in patients with poor surgical candidacy for a hysterectomy.
Time frame: 12 months
Time from start of GLP-1RA to clearance for pregnancy pursuit
Determine the time from start of GLP-1RA treatment to clearance for pregnancy pursuit in patients pursuing fertility sparing.
Time frame: 12 months
Endometrial pathologic response
Determine the endometrial pathologic response 6 months after beginning GLP-1RA treatment
Time frame: 6 months after beginning GLP-1RA treatment
Endometrial pathologic response
Determine the endometrial pathologic response 12 months after beginning GLP-1RA treatment
Time frame: 12 months after beginning GLP-1RA treatment
Length of surgery
Determine the length of staging hysterectomy surgery
Time frame: Intraoperative
Number of nights in hospital
Determine the number of nights spent in the hospital for staging hysterectomy
Time frame: 12 months
Postoperative complications
Determine the postoperative complications following staging hysterectomy
Time frame: 12 months
Patient-reported quality of life
Compare patient-reported quality of life, as measured by the EORTC QLQ-C30, v3.0 between baseline and at 6 months after beginning GLP-1RA treatment
Time frame: 6 months
Patient-reported quality of life
Compare patient-reported quality of life, as measured by the EORTC QLQ-C30, v3.0 between baseline and at 12 months after beginning GLP-1RA treatment
Time frame: 12 months
Patient-reported quality of life
Compare patient-reported quality of life, as measured by the EORTC QLQ-C30, v3.0 between baseline and at end of GLP-1RA treatment
Time frame: at either clearance for pregnancy pursuit or staging hysterectomy, which will ideally occur by 12 months after beginning study treatment
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