Tirzepatide + Levonorgestrel IUD for Endometrial Cancer
(TIDE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Shaina Bruce, MD
Principal Investigator
Penn State Cancer Institute
Are You a Good Fit for This Trial?
This trial is for people with endometrial intraepithelial neoplasia (EIN) or early-stage (grade 1) endometrial cancer who also have obesity and metabolic risk factors. Participants should be able to use a levonorgestrel IUD and receive tirzepatide injections.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Tirzepatide
Trial Overview
The study tests the combination of weekly tirzepatide injections with standard levonorgestrel IUD therapy in patients, aiming to see if this approach is safe and effective over about six months.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milton S. Hershey Medical Center
Lead Sponsor
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