This single-arm study will evaluate the feasibility, safety, and preliminary efficacy of tirzepatide in combination with standard levonorgestrel intrauterine device (LNG-IUD) therapy in patients with endometrial intraepithelial neoplasia (EIN) or grade 1 endometrioid endometrial carcinoma with co-existing obesity and metabolic risk factors. Participants will receive tirzepatide once weekly while continuing standard clinical management with an LNG-IUD. Treatment decisions will remain at the discretion of the treating physician. The primary objective is to evaluate pathologic response at approximately 6 months. Secondary objectives include changes in metabolic parameters, assessing the incidence and severity of adverse events of tirzepatide and LNG-IUD therapy, quality of life assessment, change in weight, and change in BMI.
Age ≥ 18 years
Histologically confirmed endometrial intraepithelial neoplasia (EIN) or grade 1 endometrioid EC
BMI ≥ 30 kg/m2
For participants diagnosed with grade 1 endometrioid endometrial carcinoma: clinical stage 1A disease with MRI-confirmed myometrial invasion < 50% and no evidence of metastatic disease
None
Single group
Tirzepatide
DrugTirzepatide is a dual glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 receptor agonist (GIP/GLP-1 RA) that can promote weight loss and improve metabolic parameters in patients with obesity.
Pathologic Response at 6 months from Cycle 1 Day 1
Pathologic response will be assessed at Cycle 6 Day 28, approximately 6 months after Cycle 1 Day 1, using available clinical pathology specimens, as clinically indicated. For participants undergoing definitive surgical management, pathologic response may be assessed using the hysterectomy specimen. For participants not undergoing hysterectomy, pathologic response may be assessed using an endometrial biopsy or dilation and curettage (D\&C). Pathologic response will be categorized as complete response, partial response, stable disease, or progressive disease.
Change in metabolic parameters
Hemoglobin A1c and Lipid Profile
Assessing the Incidence and Severity of Adverse Events of Tirzepatide and LNG-IUD therapy
Assess the incidence and severity of adverse events during study treatment, including adverse events considered related to tirzepatide or LNG-IUD therapy, graded according to CTCAE version 5.0 where applicable.
Quality of Life Assessment Utilizing Study 36-Item Short Form Health Survey (SF-36) Quality of Life Score
Quality of life will be assessed using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). This survey form is a questionnaire, and participants will answer 3-point and 5-point Likert Scale questions as well as yes or no questions. This survey does not provide an aggregated score as it is opinion based. If the survey shows that a patient's quality of life is being impacted due to study treatment, appropriate action will be taken at the discretion of the treating physician.
Change in Weight
Participants weight will be collected for approximately 6 months to assess change in weight while using Tirzepatide.
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