Tirzepatide and Levonorgestrel IUD Therapy for EIN and Early-Stage Endometrial Cancer

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT07812636
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Endometrial Intraepithelial Neoplasia
  • Grade 1 Endometrial Endometrioid Carcinoma
  • Metabolic Comorbidities

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Tirzepatide 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.

Study Details

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.

Key Dates

First listed
Sep 10, 2026
Start date
Nov 1, 2026
Status verified
Sep 2026
Primary completion
May 1, 2028
Completion
Aug 1, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LNG-IUD and Tirzepatide Management
    Participants will receive tirzepatide in combination with standard clinical management with an LNG-IUD. Tirzepatide will be initiated at 2.5 mg subcutaneously once weekly. Dose escalation will occur according to the study protocol based on participant tolerability and treating physician discretion. Tirzepatide will be administered for approximately 6 months.

Primary Outcome Measure

Pathologic Response at 6 months from Cycle 1 Day 1 [ Time Frame: At the end Cycle 6 Day 28 (Approximately 6 months from Cycle 1 Day 1with each cycle approximately 28 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State Cancer InstituteHersheyPennsylvania17033
Shaina Bruce
[email protected]
717-531-8144
Xin Liu
[email protected]
717-531-3073
Shaina Bruce (PRINCIPAL_INVESTIGATOR)

Find similar trials in Hershey, PA

By research site
Penn State Cancer Institute· Hershey, PA

Related Studies