Can weight-loss drugs and hormones make endometrial cancer surgery safer for obese women?
NCT ID NCT07462663
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a 28- to 54-week program of weight-loss medication (semaglutide), a hormone-releasing IUD, diet, and exercise is safe and feasible before surgery in women with early endometrial cancer and a BMI of 40 or higher. Eighty participants will be randomly assigned to either immediate surgery or the pre-surgery program. The goal is to see if the program reduces surgical risks without allowing the cancer to progress.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Semaglutide (weight-loss drug) and levonorgestrel IUD (hormonal device)
- What this could lead to
- If it works, this could point toward a safer, less invasive way to prepare for surgery in women with early endometrial cancer and severe obesity, potentially reducing surgical risks.
- What could go wrong
- This is a small pilot study (80 people) testing feasibility, not effectiveness. The pre-surgery delay could allow tumor progression, and the weight-loss drug may cause side effects like nausea or gastrointestinal issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Jan 2035
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Female participants ≥18 years old. * Histologically confirmed atypical endometrial hyperplasia/endometrial intraepithelial neoplasia (AEH/EIN) or low-risk endometrioid endometrial carcinoma, grade 1 or 2. * Disease apparently confined to the uterine corpus, assessed by expert transvaginal ultrasound and/or pelvic magnetic resonance imaging. * Low- or intermediate-risk disease according to ESGO-ESTRO-ESP 2025 criteria, including presurgical stages IA1, IA2, or IB. * Negative or focal lymphovascular space invasion, if available. * Favorable molecular profile, if available, including POLE-mutated, p53 wild-type, MMR-deficient, or NSMP estrogen receptor-positive disease. * Body mass index ≥40 kg/m² at inclusion. * Considered a candidate for surgical treatment by the multidisciplinary tumor board. * Ability to understand and sign written informed consent after receiving oral and written information about the study, including acceptance of random assignment to either standard immediate surgery or the SHAPE-ENDO multimodal pre-surgical optimization strategy. Exclusion Criteria: * FIGO stage IA3, IC, II, or higher disease. * Extensive lymphovascular space invasion, if available. * High-risk molecular profile, including p53-abnormal/mutated disease or NSMP estrogen receptor-negative disease. * Non-endometrioid histology, including serous carcinoma, clear-cell carcinoma, carcinosarcoma, mixed histology, or other high-risk histological subtypes. * Metastatic disease or suspicion of extrauterine disease. * Considered medically inoperable or "unfit" for surgery because of severe comorbidity, frailty, anesthetic contraindication, or any other clinical reason contraindicating surgical treatment. * Contraindication to GLP-1 receptor agonist therapy or progestin-based hormonal therapy, including levonorgestrel-releasing intrauterine device or oral progestins. * Previous pancreatitis, medullary thyroid carcinoma, or multiple endocrine neoplasia type 2. * Concurrent participation in another interventional pharmacological clinical trial. * Any condition that, in the investigator's judgment, may compromise participant safety, interfere with protocol compliance, or make participation inappropriate.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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