Not yet recruitingPhase 2

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

A Randomized, Window of Opportunity Trial of Tirzepatide in Women With Obesity and a Diagnosis of Endometrial Intra-epithelial Neoplasia (EIN) or Grade 1 Endometrial Cancer

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight, Oncology

Eligibility highlights

•BMI ≥30•Female

Primary endpoint

•Anti-proliferative effect of Tirzepatide

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07078838

Org study IDLCCC2502

Secondary IDU01CA281026

Timeline

Milestones

Study first posted2025-07-22actual

Last update posted2026-01-16actual

Study start2026-04estimated (month precision)

Primary completion2029-03estimated (month precision)

Study completion2029-03estimated (month precision)

Assets

Investigational agents

Tirzepatide

Who this study enrolls

Obesity / overweightOncology

Who can enroll

Minimum age18 Years

SexFemale

Healthy volunteersNot accepted

Inclusion criteria

•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 criteria

•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.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Response to treatment

Time frame:At 4th week (during surgery)

threshold achievement, improvement

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Anti-proliferative effect of Tirzepatide

Time frame:At 4th week (during surgery)

descriptive

Secondary/protocol endpoint/low confidence

The Ki-67/caspase-3 ratio change

Time frame:At 4th week (during surgery)

ratio, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.