Tirzepatide in Women With Obesity and Endometrial Intra-epithelial Neoplasia or Grade 1 Endometrial Cancer
- Status
- Not yet recruitingResults none
- Why it is watched
- non-weight indication: cancer
- Who it enrolls
- age 18 Years to no upper limit; female; excludes diabetes; no BMI minimum stated; conditions: Endometrial Cancer; Endometrial Intraepithelial Neoplasia; Grade 1 Endometrial Endometrioid Carcinoma
- Interventions
- Tirzepatide
- Conditions
- Endometrial Cancer; Endometrial Intraepithelial Neoplasia; Grade 1 Endometrial Endometrioid Carcinoma
- Phase and size
- Phase 2 · 40 participants
- Dates
- Start 2026-08
Primary completion 2029-03 - Sponsor
- UNC Lineberger Comprehensive Cancer Center (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Anti-proliferative effect of TirzepatideAt 4th week (during surgery)
02Eligibility
Who can take part
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.
03Change log
Registry changes
No changes recorded since the trial was added.