Semaglutide, Weight Loss, and LNG-IUD for Conservative Treatment of Endometrial Atypical Hyperplasia and Grade 1 Endometrial Cancer

Plain-language guide to NCT07820358: phase 2 interventional trial of Semaglutide, endometriosis, 48 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT07820358
Phase: phase 2
Status: not yet recruiting
Start: 2027-01-01
Completion (planned or actual): 2028-12-31
Participants: 48 (estimated)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Endometrial Atypical Hyperplasia; Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia; Endometrial Cancer Stage I; Endometrial Cancer; Fertility-Sparing Treatment (FST); Obesity & Overweight
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 2 trial, researchers set out to test Semaglutide for endometriosis and fat loss, obesity & body recomposition.

The goal of this clinical trial is to learn if a combination treatment of a hormonal intrauterine device (LNG-IUD), semaglutide, and a structured weight loss program can treat endometrial atypical hyperplasia or grade 1 endometrioid endometrial cancer while preserving fertility in women of reproductive age with endometrial atypical hyperplasia (EAH) or FIGO grade 1 endometrioid endometrial cancer who wish to preserve their fertility.

The main questions it aims to answer are: * What proportion of participants achieve a complete pathological response after treatment? * How durable is the response at 12 months? * What effect does the treatment have on metabolic outcomes (weight, BMI, HbA1c) and quality of life?

It had 1 arm (groups): Combination Fertility-Sparing Treatment (experimental).

The registry classes the interventions as behavioral, device and drug.

Who Took Part

Enrollment: 48 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: Histological Diagnosis: Histologically confirmed endometrial atypical hyperplasia or FIGO grade 1 endometrioid Endometrial Cancer. Imaging eligibility (for patients with endometrial cancer):. No evidence of extrauterine or metastatic disease on imaging. Treatment Rationale (at least one of the following must apply):. Medical inoperability: patients are considered a poor surgical candidate due to:.

The full record lists 14 inclusion and 5 exclusion criteria; among the exclusions: age ≥18 years; negative pregnancy test at screening; ability to provide written informed consent and comply with study procedures.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Semaglutide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2027-01-01 with completion listed for 2028-12-31.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Pathological Response Rate (time frame: 6 months).

It also tracked 5 secondary outcomes, for example Time to response, Adverse events, Durable response rate, Disease progression rate and Recurrence rate.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Semaglutide in 48 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 Semaglutide compound page, Endometriosis research, Fat loss, obesity & body recomposition research.

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.