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

Study acronym: TIDE
StatusNot Yet Recruiting
PhaseEarly Phase 1
Started2026-11-01
View on ClinicalTrials.gov ↗
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.
Trial Details
NCT Number NCT07812636
Lead Sponsor Milton S. Hershey Medical Center
Conditions Grade 1 Endometrial Endometrioid Carcinoma, Endometrial Intraepithelial Neoplasia, Metabolic Comorbidities
Enrollment 15 participants
Start Date 2026-11-01
Primary Completion 2028-05-01 (estimated)
Study Completion 2028-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-10