Can a Weight-Loss drug and an IUD treat early uterine cancer without surgery?
NCT ID NCT07820358
First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time
Summary
Researchers are testing whether a combination of semaglutide (Wegovy), a levonorgestrel-releasing intrauterine device (LNG-IUD), and a structured weight loss program can treat endometrial atypical hyperplasia or early-stage, grade 1 endometrioid endometrial cancer in women who want to preserve their fertility. The trial enrolls 48 women of reproductive age with these conditions. Participants receive the IUD, weekly semaglutide injections, and weight loss support for six months, then undergo hysteroscopy to check for cancer regression. The study also tracks metabolic changes like weight and blood sugar, quality of life, and how long any response lasts.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- semaglutide (Wegovy) plus a levonorgestrel-releasing intrauterine device and a structured weight loss program
- What this could lead to
- If it works, this combination could offer women with early endometrial cancer or atypical hyperplasia a way to treat the disease without surgery, keeping the option of pregnancy open.
- What could go wrong
- This is a small Phase 2 trial, so even positive results would need confirmation in larger studies. Semaglutide can cause nausea, vomiting, and other digestive side effects, and the IUD can cause cramping or bleeding. Some participants may not respond, and the cancer could progress, requiring standard surgery.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 48 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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Dec 2031
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: 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.
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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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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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
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Houston Methodist Sugar Land
Houston, Texas, 77030, United States
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Houston Methodist Willowbrook
Houston, Texas, 77030, United States
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Houston Methodist Woodlands
Houston, Texas, 77030, United States
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Houston Methodist at The Medical Center
Houston, Texas, 77030, United States
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