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
Eligible age
18+ yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Florida
You may qualify if…
- ✓ 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
- ✓ For those with endometrial cancer, no extrauterine involvement or myometrial invasion by MRI (preferred) or transvaginal ultrasound
- ✓ BMI ≥ 30 kg/m2 and one of the following (per medical record or self-report):
- ✓ 1. Multiple medical co-morbidities (defined as American Society of Anesthesiologists \[ASA\] score ≥ 3) at physician discretion
- ✓ 2. Fertility desire
You may not qualify if…
- ✕ 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
- ✕ Subjects who are confirmed to be pregnant or breastfeeding
- ✕ History of medullary thyroid cancer
- ✕ Subjects with known current or history of hormonally- sensitive carcinoma (e.g., breast, melanoma)
- ✕ Subjects actively taking GLP-1RA for more than 14 days at time of consent.
Where it's recruiting
Gainesville
Source: ClinicalTrials.gov · NCT07107334 · last updated 2026-06-08