Semaglutide, a hormonal IUD and weight loss for early womb lining cancer
Tests semaglutide, a hormonal IUD and weight loss in women wanting to preserve fertility.
Plain-language title generated from the registry record
Registry title: Semaglutide, Weight Loss, and LNG-IUD for Conservative Treatment of Endometrial Atypical Hyperplasia and Grade 1 Endometrial Cancer
Key facts
- Where
- Houston, United StatesSee the 4 sites
- Phase
- Phase 2
Where in United States
- Houston Methodist at The Medical CenterHouston, United StatesNo longer taking part
- Houston Methodist Sugar LandHouston, United StatesNo longer taking part
- Houston Methodist WillowbrookHouston, United StatesNo longer taking part
- Houston Methodist WoodlandsHouston, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Methodist Hospital Research Institute
- Trial code
- NCT07820358
- Record updated
- 1 October 2026
- Original description
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:Read full original descriptionShow less
Semaglutide, Weight Loss, And Intrauterine Therapy For Fertility-Sparing And Conservative Treatment For Endometrial Atypical Hyperplasia And Early-Stage, Grade 1 Endometrioid Endometrial Cancer
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
Inclusion: Histological Diagnosis: Histologically confirmed endometrial atypical hyperplasia or FIGO grade 1 endometrioid Endometrial Cancer; Imaging eligibility (for patients with endometrial cancer):; Depth of myometrial invasion <50% confirmed by MRI or disease limited to the endometrium; No evidence of extrauterine or metastatic disease on imaging; Treatment Rationale (at least one of the following must apply):; Desire for future fertility: Patient expresses a documented desire to preserve the uterus and future reproductive function, with explicit acknowledgment that fertility-sparing treatment is not standard of care for endometrial cancer; Medical inoperability: patients are considered a poor surgical candidate due to:; Class III obesity (BMI ≥40 kg/m²); or ii. ASA Physical Status Classification score ≥3; Metabolic Profile: BMI ≥ 30 kg/m², or BMI 27-29.9 kg/m² with at least one weight-related comorbidity (hypertension, type 2 diabetes mellitus, dyslipidemia, obstructive sleep apnea, or non-alcoholic fatty liver disease); Progestin washout: patients with prior progestin exposure are eligible provided the following minimum washout periods have been observed; Oral progestins: 7 days; Injectable, short acting: 14 days; Injectable, long acting: 6 months; Contraceptive implant: 28 days; LNG-IUD: 7 days after removal.
Exclusion: Age ≥18 years; Negative pregnancy test at screening; Ability to provide written informed consent and comply with study procedures; Willingness to undergo genetic counseling and MMR/IHC tumor profiling; Willingness and ability to participate in a structured weight loss program, including attendance at counseling sessions (in person or virtual) and adherence to dietary and physical activity goals.