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NOT YET RECRUITING
NCT07820358
PHASE2

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

Sponsor: The Methodist Hospital Research Institute

View on ClinicalTrials.gov

Summary

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? Participants will: * Receive an LNG-IUD * Receive semaglutide 2.4mg * Participate in a structured weight loss program * Undergo hysteroscopy with endometrial sampling to assess treatment response * Complete quality-of-life assessments at baseline, 6 months, and 12 months

Official title: Semaglutide, Weight Loss, And Intrauterine Therapy For Fertility-Sparing And Conservative Treatment For Endometrial Atypical Hyperplasia And Early-Stage, Grade 1 Endometrioid Endometrial Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2027-01-01

Completion Date

2031-12-31

Last Updated

2026-10-01

Healthy Volunteers

No

Interventions

DRUG

Semaglutide (Wegovy) weekly injection

Semaglutide 2.4 mg administered subcutaneously once weekly, following standard dose-escalation protocol, for the duration of the 6-month active treatment period. Used off-label in this trial for its metabolic effects in combination with LNG-IUD, rather than as monotherapy for weight loss.

DEVICE

LNG-IUD (Progestin)

Levonorgestrel-releasing intrauterine device inserted at study baseline and maintained through the active treatment and follow-up periods, providing continuous local progestin delivery to the endometrium in combination with systemic semaglutide.

BEHAVIORAL

Structured Weight Loss Program

A structured, protocol-defined weight loss program combining dietary counseling and physical activity guidance, delivered concurrently with pharmacologic and device-based treatment to support metabolic response, distinct from weight loss achieved through semaglutide alone.

Locations (4)

Houston Methodist at The Medical Center

Houston, Texas, United States

Houston Methodist Sugar Land

Houston, Texas, United States

Houston Methodist Willowbrook

Houston, Texas, United States

Houston Methodist Woodlands

Houston, Texas, United States