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.
Adults ≥ 18 years old
A pathological diagnosis with in the past 4 months consistent with grade 1 endometrioid endometrial adenocarcinoma or EIN
For subjects with a diagnosis of endometrial intraepithelial neoplasia/grade 1 endometrioid endometrial adenocarcinoma prior to enrollment in the study, and with a diagnosis made outside this institution, the diagnostic material originating from outside the study site will undergo in-house pathology review before enrollment acceptance.
ECOG Performance Status of 0 to 3
Subjects with grade 2 or 3 endometroid or any non-endometrioid histology (i.e., clear cell, carcinoma, serous)
Clinical suspicion of metastatic disease as assessed by the treating physician or confirmed metastatic disease based on imaging
Subjects with abnormal cervical cytology
Subjects who are diagnosed with thyroid cancer, pancreatitis, or multiple endocrine neoplasia syndrome type 2
Single group
Glucagon-like peptide 1 receptor agonist
DrugSubjects 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 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.
Endometrial pathologic response
Determine the endometrial pathologic response 6 months after beginning GLP-1RA treatment
Endometrial pathologic response
Determine the endometrial pathologic response 12 months after beginning GLP-1RA treatment
Length of surgery
Determine the length of staging hysterectomy surgery
Number of nights in hospital
Determine the number of nights spent in the hospital for staging hysterectomy
Postoperative complications
Determine the postoperative complications following staging hysterectomy
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
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