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

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.