Tirzepatide in Obesity-Driven Endometrial Cancer

What Was Tested

This registered early phase 1 trial tested Tirzepatide for endometriosis.

This is a pre-operative window clinical study.

Endometrial biopsy samples from patients before tirzepatide treatment will be compared to their post-intervention hysterectomy specimens.

It had 1 arm (groups): endometrial carcinoma (experimental).

Obese women with endometrial carcinoma are included.

The registry classes the interventions as drug.

More on the Plan

The effect of tirzepatide on the endometrium of 20 obese women with EC will be evaluated by comparing each patient's endometrial biopsy before tirzepatide treatment to their post-treatment hysterectomy specimen, through a pre- operative window study.

These women will begin tirzepatide treatment for 4 weeks prior to standard-of-care (SOC) surgery.

Subjects will have a single end-of-treatment visit 4 weeks after completing therapy and will be followed for 24 months via medical record abstraction to monitor weight loss maintenance.

Who Took Part

The registry lists 20 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: Agree to comply with all required study assessments and visits including internet capabilities. Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Age ≥ 18 at the time of consent. Body mass index of ≥30 kg/m2. Presumed clinically early-stage disease (disease confined to uterus only).

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: active infection requiring systemic therapy; subject is pregnant or breast feeding; taking any prescription medications or other drugs that may influence metabolism per discretion of investigator.

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 2026-04-27 with completion listed for 2028-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Proliferation (time frame: Baseline - Up to 6 weeks).

It also tracked 13 secondary outcomes, for example Change in circulating levels of inflammatory cytokines, Change in sex hormones, Change in Lipids, Change in insulin, Change in Insulin-like Growth Factor 1 and Change in glucose.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Tirzepatide in 20 people with endometriosis.

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

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, Endometriosis research.