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

Launched by UNC LINEBERGER COMPREHENSIVE CANCER CENTER · Jul 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medicine called tirzepatide can help women with obesity who have early-stage changes or cancer in the lining of the uterus (called endometrial intraepithelial neoplasia or Grade 1 endometrial cancer). Researchers want to see if tirzepatide can slow down or stop the growth of abnormal cells in the uterus. This medicine may work by helping the body’s metabolism (how it handles sugar and fat) and by directly affecting the unhealthy cells. Since obesity is closely linked to these uterine conditions, tirzepatide might offer a double benefit of helping with weight loss and fighting the tumor.

Women who are 18 years or older, have a body mass index (BMI) over 30 (which means they are obese), and have a confirmed diagnosis of these early uterine changes or cancer may be eligible. Participants will be randomly assigned to either receive tirzepatide or not for about 4 weeks before having standard surgery to remove the uterus. Those taking tirzepatide will use a glucose monitor to track their blood sugar and keep a diary of their medication use and any side effects. After surgery, all participants will be referred to a weight loss clinic to support healthy lifestyle changes. This study is not yet recruiting, but it aims to find out if tirzepatide can be a helpful treatment for women facing these uterine conditions linked to obesity.

Gender

FEMALE

Eligibility criteria

• 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.