Loxenatide Plus LNG-IUS in Endometrial Atypical Hyperplasia

• Status: Not yet recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

To study if polyethylene glycol loxenatide plus levonorgestrel-releasing intrauterine system (LNG-IUS) will improve response rates in patients with endometrial atypical hyperplasia.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Levonorgestrel

Criteria

Inclusion Criteria:

• BMI (body mass index) ≥28kg/m2

• Consent informed and signed

• Pathologically confirmed as endometrial atypical hyperplasia

• Have a strong desire to reproduce and ask for fertility preservation or those who insist on keeping the uterus despite no reproductive requirements

• Have good compliance and follow-up conditions, and patients are willing to follow up in Obstetrics and Gynecology Hospital of Fudan University in time

Exclusion Criteria:

• Diagnosed as type 2 diabetes

• Diabetic ketoacidosis

• History of acute pancreatitis

• Have a history or family history of medullary thyroid carcinoma; multiple endocrine neoplasia syndrome type 2 (MEN2)

• Combined with severe medical disease or severely impaired liver and kidney function

• Patients with other types of endometrial cancer or other malignant tumors of the reproductive system; patients with breast cancer or other hormone- dependent tumors that cannot be used with progesterone

• Those who require hysterectomy or other methods other than conservative treatment with drugs

• Known or suspected pregnancy

• Currently suffering from pelvic inflammatory disease or diagnosed as pelvic inflammatory disease

• Lower reproductive system infection

• abnormal cervical dysplasia

• Congenital or acquired uterine abnormalities, including fibroids that deform the uterine cavity

• Allergic to any parts of LNG-IUS components

• The uterine cavity is too large (average diameter is over 7cm) or the history of LNG-IUS falling off