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

NCT05829460 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-01-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Andrea R Hagemann, M.D., MSCI · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-12
Primary Completion
2030-04-30
Completion
2032-04-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05829460 on ClinicalTrials.gov