Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Low-grade Cancer of the Endometrium

NCT06073184 · Not yet recruiting

Last updated 2026-05-28

This clinical trial is testing whether a weight-loss drug can help shrink precancerous changes or early-stage cancer in the lining of the uterus in women who are overweight or obese.

Status Not yet recruiting Approved but enrollment has not started.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design open-label (no blinding) treatment study

Participants 71 people Planned (estimated).

Who can join Ages 18–41 · female only

Timeline Started 2025-08 · est. completion 2032-02

What this study is testing ClinicalTrials.gov NCT06073184 ↗

Description as written by the study sponsor.

The incidence of endometrial cancer is increasing at an alarming rate. This trend parallels the rising rate of obesity, the most significant risk factor for endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia who want to maintain their fertility are treated with progestin therapy, such as progestin intra-uterine device (pIUD), which is associated with a mediocre response rate and high recurrence rate, and does not address the underlying cause, obesity. Therefore, the investigators want to assess whether the addition of a weight-loss drug to pIUD will improve their oncologic, reproductive and metabolic outcomes.

Treatments tested

Mounjaro also known as Tirzepatide Drug

Weekly subcutaneous injection of 2.5mg tirzepatide at baseline with dose escalation by 2.5mg every 4 weeks to reach 15mg or the maximum tolerated dose, by Week 20
Mirena also known as Progestin-releasing intra-uterine device (pIUD) Drug

Levonorgestrel-releasing Intrauterine System (52mg) to deliver up to 20 mcg levonorgestrel per day

Main thing measured	Assessment of Complete Pathologic Response
Sponsor	University Health Network, Toronto
Conditions studied	Endometrial Cancer, Atypical Hyperplasia
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06073184 ↗