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

University of Florida

Status and phase

Begins enrollment this month

Phase 2

Conditions

Endometrioid Endometrial Adenocarcinoma

Treatments

Drug: Glucagon-like peptide 1 receptor agonist

Study type

Interventional

Funder types

Other

Identifiers

NCT07107334

UF-GYN-XXX

Details and patient eligibility

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.

Enrollment

30 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.