Actively Recruiting
A Pilot Study to Estimate Early Clinical Efficacy Signals of a Glucagon-like Peptide 1 Receptor Agonist (GLP-1RA) with Levonorgestrel Intrauterine Device in Obese Patients with Endometrioid Endometrial Neoplasia
Led by University of Florida · Updated on 2026-06-08
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the combined use of glucagon-like peptide 1 receptor agonists (GLP-1RA) with a levonorgestrel intrauterine device in obese patients diagnosed with endometrioid intraepithelial neoplasia or grade 1 endometrial adenocarcinoma. It focuses on patients who are either poor candidates for hysterectomy surgery or wish to preserve fertility. GLP-1RAs are medications that mimic a natural hormone to help control blood sugar and have recently been approved for weight loss, with potential effects on obesity-related cancers, including endometrial cancer, that are still being studied. Participants will receive one of several GLP-1RA medications, such as semaglutide, tirzepatide, or liraglutide, either by self-injection or orally, as chosen by their treating physician. This treatment continues until they are cleared for either hysterectomy staging surgery or to pursue pregnancy. The levonorgestrel intrauterine device is used concurrently. Subjects will stop the GLP-1RA two weeks before any planned surgery. The study is a phase 2 interventional trial sponsored by the University of Florida. During the study, researchers will monitor the time until participants are cleared for surgery or pregnancy and assess the endometrial tissue response after 6 and 12 months of treatment. They will also track surgical details, hospital stay length, postoperative complications, and patient-reported quality of life at several time points. The total participation duration is up to 12 months, with various evaluations, imaging, and pathology reviews to assess the treatment effects and safety.
CONDITIONS
Brief 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 or older
- Pathological diagnosis within the past 4 months of grade 1 endometrioid endometrial adenocarcinoma or endometrial intraepithelial neoplasia
- In-house pathology review of external diagnostic material before enrollment
- ECOG Performance Status between 0 and 3
- No extrauterine involvement or myometrial invasion by MRI or transvaginal ultrasound
- Body mass index (BMI) of 30 kg/m2 or higher
- Presence of either multiple medical co-morbidities (ASA score 3 or higher) or desire to preserve fertility
- Appropriate age-related breast exams and imaging completed prior to enrollment
- Written informed consent and willingness to comply with study procedures
You will not qualify if you...
- Grade 2 or 3 endometrioid or any non-endometrioid histology
- Clinical suspicion or confirmation 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
- Known current or history of hormonally-sensitive carcinomas such as breast cancer or melanoma
- Prior use of GLP-1RA for more than 14 days before consent
- Levonorgestrel-releasing intrauterine device placed more than 45 days before enrollment
- More than one active malignancy at enrollment unless deemed safe by physician
- Any disease or condition that contraindicates protocol therapy or risks treatment complications
- Prisoners, involuntarily incarcerated individuals, or those compulsorily detained for psychiatric or physical illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months or until clearance for staging hysterectomy or pregnancy pursuit
Participants receive a glucagon-like peptide 1 receptor agonist by self-injection or orally as clinically indicated by their physician until clearance for staging hysterectomy or pregnancy pursuit.
Regular visits as per physician discretion
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
Research Team
S
Stephanie Portillo
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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