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

NCT05829460•Washington University School of Medicine

Summary

The investigators hypothesize that combined treatment with the GLP-1R agonist semaglutide 2.4 mg and levonorgestrel intrauterine device (LNG-IUD), compared to LNG-IUD alone, will result in improved likelihood of uterine preservation, sustained weight loss, improved endometrial and metabolomic response to progestin, and improved quality of life in premenopausal women with endometrial hyperplasia who desire uterine preservation.

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Diagnosis of histologically confirmed non-atypical endometrial hyperplasia (EH) or complex atypical endometrial hyperplasia (AEH).
•* Patients with a previous diagnosis of EH or AEH who are already being followed with conservative management with oral or LNG-IUD progestin therapy are eligible provided they have not previously been on a GLP-1R agonist within 3 months prior to enrollment.
•* For patients with a previous diagnosis of EH or AEH who have been placed on progestin prior to study entry, the duration of IUD or oral progestin use prior to trial entry should be less than or equal to 6 months.
•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.
•Prior or current receipt of progestin is allowed as above. Willingness to undergo placement of LNG-IUD at the time of study entry.
•Prior or current receipt of metformin is allowed.
•Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria

•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.
•Acute decompensation of glycemic control.
•Concomitant use of other weight management drugs or drugs for short-term weight loss.
•History of surgery or use of a device to treat obesity.
•Uncontrolled thyroid disease
•Acute coronary or cerebrovascular event in the previous 60 days.
•Currently planned coronary, carotid, or peripheral artery revascularization.
•Chronic heart failure (NYHA class IV).
+12 more criteria

Key Dates

Start Date

March 12, 2025

Primary Completion Date

April 30, 2030

Completion Date

April 30, 2032

Last Updated

January 12, 2026

Conditions

Endometrial Hyperplasia

Interventions

Semaglutide

DRUG

Placebo

DRUG

LNG-IUD (Progestin)

DRUG

Telemedicine behavioral weight program

BEHAVIORAL

Uterine Preservation Via Lifestyle Transformation

NCT05903131

Endometrial HyperplasiaGrade 1 Endometrial Cancer

View study

RECRUITING

Surgical and Obstetric Outcomes in Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia With Conservative Treatment

NCT07077876

Endometrial AdenocarcinomaEndometrial Hyperplasia+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Uterine Preservation Via Lifestyle Transformation

Surgical and Obstetric Outcomes in Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia With Conservative Treatment

Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC

Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer

Progestins for the Treatment of Endometrial Cancer or Precancers of the Uterus Before Surgery, The Pro-Window Trial

POPQ Associated With Total Laparoscopic Hysterectomy