Tirzepatide in Women With Obesity and Endometrial Intra-epithelial Neoplasia or Grade 1 Endometrial Cancer

What Was Tested

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

EIN is considered a precursor to EC.

It had two arms (groups): tirzepatide (experimental) and No tirzepatide (no intervention).

No tirzepatide arm will not receive tirzepatide, and Standard Operating Procedures will be applied.

The registry classes the interventions as drug.

Who Took Part

40 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: Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. The subject is willing and able to comply with study procedures based on the judgement of the investigator. Age \> 18 years at the time of consent. ECOG ≤ 2 or Karnofsky Performance Status of \>50. Subject must have archival EC tissue available.

The full record lists 8 inclusion and 11 exclusion criteria; among the exclusions: active infection requires systemic therapy; subject is pregnant or breast breastfeeding, or planning to become pregnant at any time during the study; taking any prescription medications or other drugs that influence weight change in the past 3 months.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the endometriosis participants stayed in one arm throughout.

Being open-label, the Tirzepatide study did not mask who received what.

It started in 2027-01 with completion listed for 2029-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Anti-proliferative effect of Tirzepatide (time frame: At 4th week (during surgery)).

It also tracked 2 secondary outcomes, for example The Ki-67/caspase-3 ratio change and Response to treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 40 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.