A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer

What Was Tested

In this phase 2 trial, researchers set out to test Tirzepatide for endometriosis and hyperparathyroidism.

It had 1 arm (groups): one (experimental).

After LNG-IUD placement at baseline or on day 0, participants then self-inject tirzepatide SC QW for 26 weeks in the absence of disease progression or unacceptable toxicity. Patients who qualify for tirzepatide or another weight loss medication as determined by primary provider may continue to receive treatment beyond 26 weeks as per standard of care.

The registry classes the interventions as drug and other.

More on the Plan

To determine the proportion of participants who achieve sustained pathologic complete response on EMB at 52 weeks (12 months) compared to historical controls.

To estimate the time to complete response and duration of response, up to 52 weeks (12 months) compared to historical controls.

To estimate percent change in cell proliferation (Ki-67+) at 12, 26, 39 and 52 weeks compared to historical controls and baseline.

To estimate percent change in hemoglobin A1C (HbA1C) at 12, 26, 39 and 52 weeks compared to baseline.

Who Took Part

Enrollment: 55 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: For participants with a history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Participants on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible. Ability to comply with EMB every 3 months. Women currently using oral hypoglycemic agents (e.g., metformin) are eligible for the study. Ability to understand and the willingness to sign a written informed consent document in English or Spanish.

The full record lists 11 inclusion and 26 exclusion criteria; among the exclusions: women with grade 2-3 endometrioid, or women with serous, clear cell, mucinous, squamous, transitional cell, sarcomas, or carcinosarcoma histology; evidence of extrauterine spread of disease on imaging or during surgical evaluation; history of allergic reactions attributed to compounds of similar chemical or biologic composition to the levonorgestrel iud or any glp-1 agonist.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Tirzepatide study: the endometriosis participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-11-01 with completion listed for 2029-10-31.

It ran at 3 sites in United States (3).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Weighted pathological complete response (pCR) (time frame: At 26 weeks).

It also tracked 7 secondary outcomes, for example Proportion of participants who achieve pCR on endometrial biopsy, Time to complete response and duration of response, Rate of hyperplasia persistence and progression to EC, Percent change in cell proliferation, Percent change in hemoglobin A1C and Percent weight change.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Tirzepatide in 55 people with endometriosis.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, Endometriosis research, Hyperparathyroidism research.