Loxenatide Plus LNG-IUS in Endometrial Atypical Hyperplasia

NCT05172999 · Completed

Last updated 2026-05-28

This clinical trial is testing whether the combination of loxenatide (a diabetes medication) and a levonorgestrel intrauterine system (LNG-IUS) can help reduce abnormal uterine cell growth in women with atypical endometrial hyperplasia who also have obesity or fertility concerns.

Status Completed The study has finished.

Phase Phase2, Phase3

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 30 people

Who can join Ages 18–45 · female only

Timeline Started 2022-01 · est. completion 2026-02

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT05172999 ↗

Description as written by the study sponsor.

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

Treatments tested

levonorgestrel-releasing intrauterine system also known as MIRENA Device

Enrolled patients will be inserted this device for treating AEH to preserve fertility for 3-6 months or longer till complete response or operation if treatment fails, and the device may be removed if treatment changes.
Polyethylene Glycol Loxenatide also known as Fulaimei, PEX168 Drug

Initiate injection of Loxenatide will be 0.1mg per week, if the patient can tolerate, the dose will be increased to 0.2mg per week, or else 0.1mg per week will be injected and the injection will last for no more than 28 weeks. If the patient cannot tolerate the least 0.1mg/week, she must be excluded from this trial.

Main thing measured	Pathological complete response (CR) rates
Sponsor	Fudan University
Conditions studied	Atypical Endometrial Hyperplasia, Obesity, Fertility Issues
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05172999 ↗