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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexFemale
• Healthy volunteersNo

You may be able to join 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):
• Multiple medical co-morbidities (defined as American Society of Anesthesiologists [ASA] score ≥ 3) at physician discretion
• Fertility desire
• Subject has had appropriate age-related breast examinations and imagining prior to study enrollment, as documented in the medical record or via investigator confirmation.
• Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.

You cannot join 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.
• Subjects with levonorgestrel-releasing intrauterine system placed >45 days prior to study enrollment.
• Subjects must not have more than one active malignancy at the time of enrollment (Subjects with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with safety or efficacy assessment of the study [as determined by the treating physician or approved by the PI] may be included).
• History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician. This includes, but is not limited to, conditions such as New York Heart Association (NYHA) Class IV heart failure.
• Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

levonorgestrel-releasing intrauterine system. A long-acting, hormone-releasing, intrauterine device consisting of a small, T-shaped, polyethylene frame and a reservoired synthetic progesterone with progestational and potential antineoplastic activities. After insertion of this system into the uterus, the device slowly and gradually releases the hormone. Levonorgestrel acts by binding to the progesterone receptor in the nuclei of target cells, resulting in transcription activation and an alteration in protein synthesis. Subsequently, luteinizing hormone (LH) activity and ovulation are suppressed. Levonorgestrel may also exhibit antiproliferative activity in endometrial tissue. NCI Drug Dictionary

Treatments listed in the registry

• Glucagon-like peptide 1 receptor agonist (Drug): 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.

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• surgery: Part of the study plan

Main goals

• Time from start of GLP-1RA to clearance of staging hysterectomy (12 months)
• Time from start of GLP-1RA to clearance for pregnancy pursuit (12 months)
• Endometrial pathologic response (6 months after beginning GLP-1RA treatment)
• Endometrial pathologic response (12 months after beginning GLP-1RA treatment)

Other goals

• Length of surgery
• Number of nights in hospital
• Postoperative complications
• Patient-reported quality of life
• Patient-reported quality of life
• Patient-reported quality of life

Planned enrollment: 20 (estimated).

• University of Florida, Gainesville, Florida

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07107334
• NCI Drug Dictionary: C52193

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 20, 2026. Public record; not medical advice.