Mazdutide Plus LNG-IUS for Fertility-Sparing Treatment of AEH or Early Endometrial Cancer

What Was Tested

In this phase 2 trial, researchers set out to test Mazdutide for endometriosis and hyperparathyroidism.

Eligible participants will be randomized in a 1:1 ratio to receive LNG-IUS plus mazdutide or LNG-IUS plus matching placebo.

The primary outcome is the complete response rate of endometrial lesions at 24 weeks after randomization.

It had two arms (groups): LNG-IUS plus Mazdutide (experimental) and LNG-IUS plus Placebo (placebo comparator).

The registry classes the interventions as device and drug.

More on the Plan

Eligible participants are premenopausal women with a strong desire to preserve fertility, diagnosed with AEH or FIGO grade 1 early-stage endometrioid endometrial cancer confined to the endometrium, and with overweight or obesity.

All participants will receive LNG-IUS.

Endometrial response will be assessed by hysteroscopic endometrial biopsy and pathology evaluation at prespecified time points.

The study will compare pathological response, time to complete response, safety, body weight and metabolic changes, reproductive endocrine parameters, subsequent pregnancy outcomes, recurrence, patient-reported outcomes, and exploratory biomarker changes between the two treatment groups.

Who Took Part

The registry lists 128 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Female participants aged 18 to 45 years. Imaging confirms disease confined to the endometrium, with no evidence of myometrial invasion, adnexal involvement, extrauterine disease, or distant metastasis. Estrogen receptor-positive disease. No contraindication to progestin therapy. Uterine cavity suitable for LNG-IUS placement.

The full record lists 13 inclusion and 17 exclusion criteria; among the exclusions: pathological diagnosis not consistent with atypical endometrial hyperplasia or eligible early endometrioid endometrial cancer; endometrioid carcinoma grade 2 or higher; or p53-abnormal molecular subtype; imaging or pathological evidence of myometrial invasion, ovarian malignancy, extrauterine disease, or distant metastasis; prior fertility-sparing drug therapy or intrauterine progestin therapy for atypical endometrial hyperplasia or endometrial cancer.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The endometriosis participants were allocated by chance, so the Mazdutide group and the comparison group should start out alike.

Groups ran in parallel: each of the endometriosis participants stayed in one arm throughout.

Blinding on both sides kept the endometriosis participants and researchers unaware of who received Mazdutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-11-01 with completion listed for 2029-06-30.

It ran at 6 sites in China (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Complete response rate of endometrial lesions at 24 week (time frame: At 24 weeks after randomization).

It also tracked 22 secondary outcomes, for example Complete response rate at 12 weeks, Complete response rate at 36 weeks, Time to first complete response, Pathological response status, Fertility-sparing treatment failure and radical surgery and Change in body weight.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Mazdutide in 128 people with endometriosis.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Mazdutide compound page, Endometriosis research, Hyperparathyroidism research.