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Weight-Loss drug meets hormonal IUD in hunt for Surgery-Free cancer care

NCT ID NCT07812636

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Penn State Cancer Institute

    Hershey, Pennsylvania, 17033, United States

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