Tirzepatide and Levonorgestrel IUD Therapy for EIN and Early-Stage Endometrial Cancer

What Was Tested

This registered early phase 1 trial tested Tirzepatide for endometriosis.

Participants will receive tirzepatide once weekly while continuing standard clinical management with an LNG-IUD.

Treatment decisions will remain at the discretion of the treating physician.

It had 1 arm (groups): LNG-IUD and Tirzepatide Management (experimental).

The registry classes the interventions as drug.

More on the Plan

Obesity has been identified as a major risk factor for endometrial carcinogenesis and is prevalent among patients with endometrial intraepithelial neoplasia (EIN) and early-stage endometrial cancer.

Levonorgestrel intrauterine device (LNG-IUD) therapy is a standard hormonal treatment for local EIN and grade 1 endometrioid endometrial carcinoma.

Eligible participants will be enrolled after initial histological confirmation of either EIN or grade 1 endometrioid endometrial carcinoma.

Clinical management will remain at the discretion of the treating physician.

Who Took Part

15 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: Age ≥ 18 years. Histologically confirmed endometrial intraepithelial neoplasia (EIN) or grade 1 endometrioid EC. BMI ≥ 30 kg/m2. Presence of at least one obesity-associated metabolic comorbidity, including:. For participants with EIN: no evidence of extrauterine disease based on clinically appropriate evaluation.

The full record lists 21 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Tirzepatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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 2028-05-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Pathologic Response at 6 months from Cycle 1 Day 1 (time frame: At the end Cycle 6 Day 28 (Approximately 6 months from Cycle 1 Day 1with each cycle approximately 28 days)).

It also tracked 5 secondary outcomes, for example Change in metabolic parameters, Assessing the Incidence and Severity of Adverse Events of Tirzepatide and LNG-IUD therapy, Quality of Life Assessment Utilizing Study 36-Item Short Form Health Survey (SF-36) Quality of Life Score, Change in Weight and Change in BMI.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Tirzepatide in 15 people with endometriosis.

Its size is small, so on its own it can only give an early look.

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.