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Semaglutide, Weight Loss, and LNG-IUD for Conservative Treatment of Endometrial Atypical Hyperplasia and Grade 1 Endometrial Cancer

Sponsored by The Methodist Hospital Research Institute

About this study

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

Where this study is enrolling (4)

Who can participate

Inclusion criteria

  • ✓1. Histological Diagnosis: Histologically confirmed endometrial atypical hyperplasia or FIGO grade 1 endometrioid Endometrial Cancer
  • ✓2. Imaging eligibility (for patients with endometrial cancer):
  • ✓1. Depth of myometrial invasion \<50% confirmed by MRI or disease limited to the endometrium
  • ✓2. No evidence of extrauterine or metastatic disease on imaging.
  • ✓3. Treatment Rationale (at least one of the following must apply):
  • ✓1. 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.
  • ✓2. Medical inoperability: patients are considered a poor surgical candidate due to:
  • ✓i. Class III obesity (BMI ≥40 kg/m²); or ii. ASA Physical Status Classification score ≥3.
  • ✓4. 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).
  • ✓5. Progestin washout: patients with prior progestin exposure are eligible provided the following minimum washout periods have been observed.
  • ✓1. Oral progestins: 7 days
  • ✓2. Injectable, short acting: 14 days
  • ✓3. Injectable, long acting: 6 months
  • ✓4. Contraceptive implant: 28 days
  • ✓5. LNG-IUD: 7 days after removal

Exclusion criteria

  • ✕1. Age ≥18 years
  • ✕2. Negative pregnancy test at screening
  • ✕3. Ability to provide written informed consent and comply with study procedures
  • ✕4. Willingness to undergo genetic counseling and MMR/IHC tumor profiling
  • ✕5. 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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.