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Tirzepatide in Obesity-Driven Endometrial Cancer

A Pre-Operative Window Study of Tirzepatide in Obesity-Driven Endometrial Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 24 months
  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Endometrial biopsy samples from patients before tirzepatide treatment will be compared to their post-intervention hysterectomy specimens."
  • "If archival tissue is unavailable, a fresh biopsy will be taken before tirzepatide treatment."
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether tirzepatide can slow cancer cell growth in the lining of the uterus before surgery. It is for adults with obesity and a type of uterine cancer called endometrioid cancer that is thought to be only in the uterus. Researchers will compare tissue taken before treatment with tissue from surgery to remove the uterus.

LCCC2415 examines the antiproliferative effect of tirzepatide on the endometrium of endometrial cancer (EC). 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. If archival tissue is unavailable, a fresh biopsy will be taken before tirzepatide treatment. Post-intervention tissue will be collected from the hysterectomy specimen. The hypothesis is that tirzepatide's anti-tumorigenic effects are due to both an improvement in the host's metabolic milieu (indirect effect) and a direct effect on the EC tumor microenvironment via the inter-related pathways of insulin, lipid, and mTOR signaling. Therefore, tirzepatide may be an innovative approach to effectively induce weight loss and inhibit tumor growth in EC, the most obesity-driven of all cancers.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have endometrioid cancer and plan to have surgery to remove the uterus and check how far the cancer has spread.
  • Agree to all required study tests and visits, and have internet access.
  • Sign forms agreeing to join the study and allowing use of personal health information.
  • Be at least 18 years old when you agree to join.
  • Have a body mass index (BMI) of 30 or higher, which is in the obesity range.
  • Have cancer that doctors think is only in the uterus.
  • Meet the required rating for daily activity and self-care: ECOG 2 or lower, or Karnofsky above 50.

Who can't join

  • Have an active infection that needs medicine that works throughout the body.
  • Are pregnant or breastfeeding.
  • Take medicines or other drugs that may affect how the body uses energy, as judged by the study doctor.
  • Take a stimulant drug that acts on the brain and nervous system.
  • Have a mental health condition that the study doctor thinks would prevent participation.
  • Have a known reaction, such as hives or eczema, to drugs called GIP or GLP-1 receptor agonists.
  • Have type 1 diabetes, have autoimmune diabetes that starts in adulthood, or use insulin.
  • Have had very low blood sugar, or cannot explain that you understand the signs of low blood sugar.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Current diagnosis of endometrioid histology cancer and scheduled to undergo hysterectomy and staging. * 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). * ECOG ≤ 2 or Karnofsky Performance Status of \> 50 Exclusion Criteria: * 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. * Taking a central nervous system stimulant. * Current psychological conditions that would be incompatible with participation in this study, as determined by investigator. * Known sensitivities (i.e., urticaria and eczema) to GIP and GLP-1 receptor agonists. * Have type 1 diabetes mellitus or latent autoimmune diabetes in adults or receiving treatment with insulin. * Have a history of severe hypoglycemia or not be able to communicate an understanding of hypoglycemic symptoms.

Study sites (1)

NC