Actively Recruiting
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
Led by University of Florida · Updated on 2026-04-09
20
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years old or older
- Diagnosed within past 3 months with grade 1 endometrioid endometrial adenocarcinoma or endometrial intraepithelial neoplasia
- Pathology reviewed in-house if diagnosis was made outside the study center
- ECOG Performance Status between 0 and 3
- No extrauterine disease or myometrial invasion by MRI or transvaginal ultrasound within last 3 months
- Body mass index (BMI) of 30 kg/m2 or higher and either multiple medical comorbidities (ASA score 3 or higher) or desire to preserve fertility
- Appropriate age-related breast exams and imaging completed before enrollment
- Written informed consent and agreement to comply with study procedures
You will not qualify if you...
- Grade 2 or 3 endometrioid or any non-endometrioid tumor types
- Tumors that are estrogen receptor negative
- Clinical or imaging evidence of metastatic disease
- Abnormal cervical cytology
- Diagnosis of thyroid cancer, pancreatitis, or multiple endocrine neoplasia syndrome type 2
- Pregnant or breastfeeding
- History of medullary thyroid cancer
- Levonorgestrel-releasing intrauterine device placed more than 14 days before enrollment
- More than one active malignancy at enrollment, unless deemed not interfering with study
- Any other disease or condition that contraindicates protocol therapy or risks complications, including NYHA Class IV heart failure
- Prisoners or involuntarily incarcerated individuals
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
Research Team
S
Stephanie Portillo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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