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Not yet recruitingPhase 2

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

Semaglutide, Weight Loss, And Intrauterine Therapy For Fertility-Sparing And Conservative Treatment For Endometrial Atypical Hyperplasia And Early-Stage, Grade 1 Endometrioid Endometrial Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a hormone-releasing device placed in the womb (LNG-IUD), semaglutide, and a weight loss program. It is for women with abnormal cells or grade 1 cancer in the womb lining who want to keep their ability to have children, or who cannot safely have surgery. Researchers will check how well treatment works, how long it works, and its effects on health and quality of life.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A tissue test confirms abnormal cells called endometrial atypical hyperplasia or grade 1 endometrioid cancer in the womb lining.
  • For cancer, scans show it is only in the lining or has grown less than halfway into the womb’s muscle wall, with no spread outside the womb.
  • You want to keep your womb and ability to have children, and understand this is not standard cancer treatment; OR surgery is unsafe because of a BMI of 40 or higher or an ASA surgery health score of 3 or higher.
  • Your BMI, a measure of weight compared with height, is 30 or higher; OR it is 27–29.9 with a weight-related condition such as high blood pressure, type 2 diabetes, unhealthy blood fats, sleep apnea, or fatty liver not caused by alcohol.
  • If you used progestin hormones, you must wait at least 7 days after pills, 14 days after short-acting shots, or 6 months after long-acting shots.
  • After other progestin treatments, you must wait at least 28 days after a birth control implant or 7 days after removal of a hormone-releasing IUD.

Who can't join

  • The listing puts the items below under reasons not to join. This may be an error; ask the study team to confirm.
  • Age 18 or older.
  • A negative pregnancy test at screening.
  • Being able to give written consent and follow study steps.
  • Being willing to get genetic counseling and tumor tests called MMR/IHC.
  • Being willing and able to join the weight loss program, attend counseling in person or online, and follow food and exercise goals.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (4)

TX