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

Not Applicable

Not yet recruiting

• Conditions: Endometrioid Endometrial Adenocarcinoma
• Interventions: Drug: Glucagon-like peptide 1 receptor agonist

• Registration Number: NCT07107334
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-23
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-06
• Study Start: 2025-11-01
• Primary Completion: 2028-11
• Study Completion: 2029-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Adults ≥ 18 years old

• A pathological diagnosis with in the past 3 months consistent with grade 1 endometrioid endometrial adenocarcinoma or endometrial intraepithelial neoplasia

• ECOG Performance Status of 0 to 3

• No extrauterine involvement or myometrial invasion by MRI (preferred) or transvaginal ultrasound with in the last 3 months

• BMI ≥ 30 kg/m2 and one of the following:

  1. Multiple medical co-morbidities (defined as American Society of Anesthesiologists [ASA] score ≥ 3) at physician discretion
  2. Fertility desire

• Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the study [as determined by the treating physician or approved by the Principal Investigator] may be included).

• Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.

Exclusion Criteria

• Subjects with grade 2 or 3 endometroid or any non-endometrioid histology (i.e., clear cell, carcinoma, serous)
• Subjects whose tumors are estrogen receptor negative
• 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
• 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.
• Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glucagon-like peptide 1 receptor agonist	Glucagon-like peptide 1 receptor agonist	-

Primary Outcome Measures

Name	Time	Method
Time from start of GLP-1RA to clearance of staging hysterectomy	12 months	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	12 months	Determine the time from start of GLP-1RA treatment to clearance for pregnancy pursuit in patients pursuing fertility sparing.
Endometrial pathologic response	12 months after beginning GLP-1RA treatment	Determine the endometrial pathologic response 12 months after beginning GLP-1RA treatment

Secondary Outcome Measures

Name	Time	Method
Length of surgery	Intraoperative	Determine the length of staging hysterectomy surgery
Number of nights in hospital	12 months	Determine the number of nights spent in the hospital for staging hysterectomy
Postoperative complications	12 months	Determine the postoperative complications following staging hysterectomy
Patient-reported quality of life	at either clearance for pregnancy pursuit or staging hysterectomy, which will ideally occur by 12 months after beginning study treatment	Compare patient-reported quality of life, as measured by the EORTC QLQ-C30, v3.0 between baseline and at end of GLP-1RA treatment