Could popular Weight-Loss drugs help treat endometrial cancer?
NCT ID NCT07107334
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study is testing whether combining a GLP-1 weight-loss drug (like semaglutide or tirzepatide) with a hormonal IUD can help obese patients with early-stage endometrial cancer avoid surgery or preserve fertility. Twenty participants will receive the drug and IUD, and researchers will track how long it takes for them to become healthy enough for surgery or pregnancy. The goal is to see if this approach can reverse precancerous changes in the uterus.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GLP-1 receptor agonist (semaglutide, tirzepatide, liraglutide, or orforglipron) plus levonorgestrel intrauterine device
- What this could lead to
- If it works, this combination could help obese patients with early endometrial cancer avoid hysterectomy or safely pursue pregnancy by shrinking or eliminating precancerous cells.
- What could go wrong
- This is a very small pilot study with only 20 participants, so results may not apply widely. GLP-1 drugs can cause nausea, vomiting, and other side effects, and the treatment may not work for everyone.
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 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Nov 2029
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: * Adults ≥ 18 years old * A pathological diagnosis with in the past 4 months consistent with grade 1 endometrioid endometrial adenocarcinoma or EIN * For subjects with a diagnosis of endometrial intraepithelial neoplasia/grade 1 endometrioid endometrial adenocarcinoma prior to enrollment in the study, and with a diagnosis made outside this institution, the diagnostic material originating from outside the study site will undergo in-house pathology review before enrollment acceptance. * ECOG Performance Status of 0 to 3 * For those with endometrial cancer, no extrauterine involvement or myometrial invasion by MRI (preferred) or transvaginal ultrasound * BMI ≥ 30 kg/m2 and one of the following (per medical record or self-report): 1. Multiple medical co-morbidities (defined as American Society of Anesthesiologists \[ASA\] score ≥ 3) at physician discretion 2. Fertility desire * Subject has had appropriate age-related breast examinations and imagining prior to study enrollment, as documented in the medical record or via investigator confirmation. * Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures. Exclusion Criteria: * Subjects with grade 2 or 3 endometroid or any non-endometrioid histology (i.e., clear cell, carcinoma, serous) * Clinical suspicion of metastatic disease as assessed by the treating physician or confirmed metastatic disease based on imaging * Subjects with abnormal cervical cytology * Subjects who are diagnosed with thyroid cancer, pancreatitis, or multiple endocrine neoplasia syndrome type 2 * Subjects who are confirmed to be pregnant or breastfeeding * History of medullary thyroid cancer * Subjects with known current or history of hormonally- sensitive carcinoma (e.g., breast, melanoma) * Subjects actively taking GLP-1RA for more than 14 days at time of consent. * Subjects with levonorgestrel-releasing intrauterine system placed \>45 days prior to study enrollment. * Subjects must not have more than one active malignancy at the time of enrollment (Subjects with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with safety or efficacy assessment of the study \[as determined by the treating physician or approved by the PI\] may be included). * History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician. This includes, but is not limited to, conditions such as New York Heart Association (NYHA) Class IV heart failure. * Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
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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
1 site. 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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University of Florida
RECRUITINGGainesville, Florida, 32608, United States
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