NCT05829460

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Hyperplasia

Interventions

Type	Name	Description
DRUG	Semaglutide	This medication is self-administered as a subcutaneous injection in the abdomen, thigh, or upper arm; injection site should be rotated when using the same body region.
DRUG	Placebo	This medication is self-administered as a subcutaneous injection in the abdomen, thigh, or upper arm; injection site should be rotated when using the same body region.
DRUG	LNG-IUD (Progestin)	Released via the levonorgestrel-releasing IUD.
BEHAVIORAL	Telemedicine behavioral weight program	Optional to attend.

Timeline

• Start date: 2025-03-12
• Primary completion: 2030-04-30
• Completion: 2032-04-30
• First posted: 2023-04-25
• Last updated: 2026-01-12

Regulatory

• FDA-regulated drug study