Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 15, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT07820358). This is a study registration, not published results. Lead sponsor: The Methodist Hospital Research Institute. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 48 participants (ESTIMATED). Conditions: Endometrial Atypical Hyperplasia, Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia, Endometrial Cancer Stage I, Endometrial Cancer, Fertility-Sparing Treatment (FST), Obesity & Overweight. Interventions: DRUG: Semaglutide (Wegovy) weekly injection; DEVICE: LNG-IUD (Progestin); BEHAVIORAL: Structured Weight Loss Program. Primary outcome measures: Pathological Response Rate , 6 months. Brief summary: The goal of this clinical trial is to learn if a combination treatment of a hormonal intrauterine device (LNG-IUD), semaglutide, and a structured weight loss program can treat endometrial atypical hyperplasia or grade 1 endometrioid endometrial cancer while preserving fertility in women of reproductive age with endometrial atypical hyperplasia (EAH) or FIGO grade 1 endometrioid endometrial cancer who wish to preserve their fertility. The main questions it aims to answer are: * What proportion of participants achieve a complete pathological response after treatment? * How durable is the response at 12 months? * What effect does the treatment have on metabolic outcomes (weight, BMI, HbA1c) and quality of life? Participants will: * Receive an LNG-IUD * Receive semaglutide 2.4mg * Participate in a structured weight loss program * Undergo hysteroscopy with endometrial sampling to assess treatment response * Complete quality-of-life assessments at baseline, 6 months, and 12 months