Phase 2Not yet recruiting
Semaglutide, Weight Loss, and LNG-IUD for Conservative Treatment of Endometrial Atypical Hyperplasia and Grade 1 Endometrial Cancer (SWIFT)
Semaglutide, Weight Loss, And Intrauterine Therapy For Fertility-Sparing And Conservative Treatment For Endometrial Atypical Hyperplasia And Early-Stage, Grade 1 Endometrioid Endometrial Cancer
- Sponsor
- The Methodist Hospital Research Institute (Academic or other)
- Enrolment
- 48 planned
- Conditions
- Endometrial Atypical Hyperplasia; Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia; Endometrial Cancer Stage I; Endometrial Cancer; Fertility-Sparing Treatment (FST); Obesity & Overweight
- Interventions
- Semaglutide (Wegovy) weekly injection; LNG-IUD (Progestin); Structured Weight Loss Program
- Ages
- adults, older adults
- Registry
- NCT07820358
Full record on ClinicalTrials.gov
From the registry
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
Primary outcomes
- Pathological Response Rate
History
Study completion expected
Primary completion expected
Expected to start
Last registry update
Registered