Weight-Loss drug meets hormonal IUD in hunt for Surgery-Free cancer care
NCT ID NCT07812636
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
Researchers are testing whether adding tirzepatide, a weekly drug that treats obesity and diabetes, to a standard levonorgestrel-releasing intrauterine device can help clear early endometrial cancer or a precancerous condition called endometrial intraepithelial neoplasia. The study enrolls 15 adults with a body mass index of 30 or higher and at least one related metabolic condition such as high blood pressure. Participants receive weekly tirzepatide while continuing usual care with the IUD, and doctors check tissue samples about six months later to see how the disease responded.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tirzepatide, a weekly weight-loss and blood-sugar drug, added to a levonorgestrel-releasing intrauterine device
- What this could lead to
- If it works, pairing a weight-loss drug with a hormonal IUD could offer some people with early endometrial cancer or precancer a way to avoid or delay surgery.
- What could go wrong
- This is a very small, early-stage study of 15 people with no control group, so any benefit could be due to chance or the IUD alone. Tirzepatide can cause nausea, vomiting, and other digestive side effects, and the cancer could still progress.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
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 1. Age ≥ 18 years 2. Histologically confirmed endometrial intraepithelial neoplasia (EIN) or grade 1 endometrioid EC 3. BMI ≥ 30 kg/m2 4. Presence of at least one obesity-associated metabolic comorbidity, including: a. Hypertension defined as: i. Documented diagnosis of hypertension, regardless of treatment status, documented in the medical records, or ii. Participants receiving antihypertensive therapy, or iii. BP ≥ 130/80 mmHg over 3 independent measurements, or iv. Single BP ≥ 160/100 mmHg b. Hyperlipidemia defined as: i. Documented diagnosis of hyperlipidemia, regardless of treatment status, documented in the medical record, or ii. Participants receiving lipid-lowering therapy, or iii. Triglycerides \> 200 mg/dL, or iv. LDL Cholesterol \> 130 mg/dL c. Type 2 Diabetes defined as: i. Documented diagnosis of Type 2 diabetes mellitus, regardless of treatment status, documented in the medical record, or ii. Receiving glucose-lowering therapy, or iii. Impaired glucose tolerance (Hgb A1c \> 6.0%) d. Diagnosed with sleep apnea 5. For participants diagnosed with grade 1 endometrioid endometrial carcinoma: clinical stage 1A disease with MRI-confirmed myometrial invasion \< 50% and no evidence of metastatic disease 6. For participants with EIN: no evidence of extrauterine disease based on clinically appropriate evaluation 7. Ability to provide informed consent and comply with study procedures and follow-up Exclusion 1. Mismatch repair-deficient (MMRd) tumors 2. p53-abnormal tumors 3. Known hypersensitivity or contraindication to either: 1. Tirzepatide, or 2. LNG-IUD 4. Prior LNG-IUD in place at the time of EIN or endometrial cancer diagnosis 5. Current systemic progestin therapy 6. Current treatment with tirzepatide or another GLP-1 receptor agonist/GLP-1-GIP receptor agonist, or prior treatment with these agents within 1 month before study enrollment 7. Type 1 diabetes or a history of pancreatitis, medullary thyroid carcinoma, or Multiple Endocrine Neoplasia syndrome type 2 (MEN2) 8. Pregnancy, breastfeeding, or intention to become pregnant during the study treatment 9. Concurrent malignancy requiring active treatment (except non-melanoma skin cancer) 10. Any medical, psychiatric, or social condition, that in the opinion of the investigator, would interfere with study participation or safety 11. Participants with diabetic eye disease, including non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema 12. Severe renal impairment, defined as eGFR \< 30 mL/min/1.73m2
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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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Penn State Cancer Institute
Hershey, Pennsylvania, 17033, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can one surgery treat endometrial cancer and obesity together?
- Can we spot cancer before it starts? a massive study aims to find out
- Could a diabetes shot help beat uterine cancer without surgery?
- Could your daily urine predict uterine cancer?
- Swab test could spot hidden uterine cancer early
- Can weight-loss drugs and hormones make endometrial cancer surgery safer for obese women?