Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia

What Was Tested

This registered phase 2 trial tested Semaglutide for endometriosis and hyperparathyroidism.

It had two arms (groups): Arm 1: Semaglutide + progestin (experimental) and Arm 2: Placebo + Progestin (active comparator).

The registry classes the interventions as behavioral and drug.

Who Took Part

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: Diagnosis of histologically confirmed non-atypical endometrial hyperplasia (EH) or complex atypical endometrial hyperplasia (AEH). Premenopausal woman with a uterus. At least 18 years of age and no more than 45 years of age. Interested in uterine preservation/fertility-sparing treatment. BMI ≥ 30 kg/m2.

The full record lists 10 inclusion and 22 exclusion criteria; among the exclusions: prior use of glp-1 receptor agonist (exenatide, liraglutide, or other) or pramlintide or any dpp-4 inhibitor in the 3 months prior to date of registration; history of type 1 diabetes; history of type 2 diabetes requiring use of insulin.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 Semaglutide.

Those kept unaware of assignments: participant and care provider.

It started in 2025-03-12 with completion listed for 2030-04-30.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of patients with endometrial hyperplasia free biopsy with uterine preservation (time frame: At 2 years (or exit from study)).

It also tracked 5 secondary outcomes, for example Time to resolution of endometrial hyperplasia (EH), Change in weight, Change in Cancer Worry Impact of Events Scale (CWIES), Change in Impact of Weight on Quality of Life (IWQOL-Lite) and Hyperplasia-free survival.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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