Back to search results

Tirzepatide for Endometrial Intra-epithelial Neoplasia or Grade 1 Endometrial Cancer

This study is testing a drug called tirzepatide in women who have obesity and either endometrial intra-epithelial neoplasia (EIN), which is a pre-cancerous condition, or Grade 1 endometrial cancer (a type of uterine cancer). Researchers want to see if tirzepatide can slow down or stop the growth of abnormal cells in the uterus. They believe tirzepatide might work by improving overall metabolic health and by directly affecting these abnormal cells. You would receive tirzepatide weekly for four weeks before surgery. The study aims to enroll 40 women and is currently unclear if it's recruiting.

Study design
This interventional study plans to enroll 40 women. It will compare tissue samples from patients who receive tirzepatide to those who do not.
What's involved
You would receive a 5 mg dose of tirzepatide weekly, given as an injection under the skin, for four weeks before your scheduled surgical staging.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, the anti-proliferative effect of tirzepatide, is measured at the 4th week, during surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07078838

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

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
UNC Lineberger Comprehensive Cancer Center
~40 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Tirzepatide

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Anti-proliferative effect of Tirzepatide
Measured over At 4th week (during surgery)

Conditions

Endometrial Cancer
Endometrial Intraepithelial Neoplasia
Grade 1 Endometrial Endometrioid Carcinoma

Explore related trials

Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial NeoplasiaEndometrial Carcinoma

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Victoria Bae-Jump · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center

Who to contact

Chelsea Baker
[email protected]
(919)-843-5230
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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
Histological or cytological evidence/confirmation of endometrial intraepithelial neoplasia (EIN) or grade 1 endometrioid histology endometrial cancer (EC) and scheduled to undergo standard of care hysterectomy and staging.
Subject must have archival EC tissue available.
Body mass index of \>30kg/m2
Demonstrate adequate organ function as defined in the protocol, all screening labs to be obtained within 28 days prior to initiating study treatment

Exclusion

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.
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 are receiving treatment with insulin.
Have a history of severe hypoglycemia or not be able to communicate an understanding of hypoglycemic symptoms.
Have a history of acute or chronic pancreatitis or serum lipase/amylase \>2X ULN or fasting triglyceride \>500 mg/dL at screening.
Have a diagnosis of gastroparesis, history of bariatric surgery, or a clinically significant gastric emptying abnormality.
Have a history or family history of multiple endocrine neoplasia, thyroid C-cell hyperplasia, or medullary thyroid carcinoma.
Currently receiving another treatment for EIN or EC.
Any condition, in the opinion of the investigator, which would prohibit safe participation.

What this trial measures

  • Anti-proliferative effect of TirzepatideAt 4th week (during surgery)

    Anti-proliferative effect of Tirzepatide will be measured via Immunohistochemistry analysis using multi-color fluorescence assays to assess Ki-67 staining.