Tirzepatide and LNG-IUD for Endometrial Hyperplasia and Grade 1 Endometrial Cancer
This study is looking at whether adding tirzepatide injections to a levonorgestrel intrauterine device (LNG-IUD) can help women with certain uterine conditions. These conditions are endometrial atypical hyperplasia/endometrial intraepithelial neoplasia (AH/EIN), which is a precancerous condition where the lining of the uterus grows abnormally, or grade 1 endometrial cancer. The study is for women who are overweight or obese and want to avoid surgery. Researchers want to see if this combination treatment can lead to a "pathological complete response" (pCR), meaning no cancer cells are found in tissue samples after treatment. The study plans to enroll 55 women. The current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 55 women.
- What's involved
- Participants will undergo LNG-IUD placement and receive tirzepatide injections under the skin. The primary outcome is measured at 26 weeks, with follow-up for some outcomes up to 52 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for some outcomes up to 52 weeks (12 months) after treatment.
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NCT07349641
A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer
Not Yet Recruiting
PHASE2Ages 18+InterventionalPreventionNational Cancer Institute (NCI)Government-funded
~55 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Medical Device Usage and EvaluationTirzepatide
At a glance
Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Weighted pathological complete response (pCR)
Measured over At 26 weeks
Conditions
Where it's being run
3 sites across 2 statesTexas2
Illinois1
Study leadership
- Roni N Wilke · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Women who have a pathologic diagnosis of AH/EIN or grade 1 endometrioid endometrial cancer confirmed on dilation and curettage (D\&C) and desire non-surgical management, who are overweight (body mass index \[BMI\] ≥ 27 kg/m\^2) with a weight-related comorbidity (hypertension, type 2 diabetes, or high cholesterol) or obese (BMI ≥ 30 kg/m\^2) with or without weight-related comorbidities
Prior progesterone treatment for conditions other than AH/EIN or endometrial cancer is allowed, but a 28-day washout period is required before levonorgestrel IUD placement. If archival tissue is available from prior to any progesterone treatment but after the diagnosis of AH/EIN/EC, the washout period is not needed
Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of tirzepatide in participants \< 18 years of age, children and adolescents \< 18 years of age are excluded from this study but will be eligible for future pediatric trials, if applicable
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For participants with a history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load
Participants on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible
Ability to comply with EMB every 3 months
Women currently using oral hypoglycemic agents (e.g., metformin) are eligible for the study
Ability to understand and the willingness to sign a written informed consent document in English or Spanish
Exclusion
Women with grade 2-3 endometrioid, or women with serous, clear cell, mucinous, squamous, transitional cell, sarcomas, or carcinosarcoma histology
Evidence of extrauterine spread of disease on imaging or during surgical evaluation
Participants may not be receiving any other investigational agents or anticancer therapies (including chemotherapy, radiation therapy, hormonal, or antibody-based therapy). Prior treatment should have a minimum washout period of 14 days
History of allergic reactions attributed to compounds of similar chemical or biologic composition to the levonorgestrel IUD or any GLP-1 agonist
Uncontrolled intercurrent illness, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study. Because of this, a pregnancy test is part of the screening for the study and women who are pregnant or planning pregnancy within 6 months after the end of the study will be excluded. The LNG-IUD is an Food and Drug Administration (FDA)-approved contraceptive agent. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.
Women who have any severe and/or uncontrolled medical conditions such as:
Unstable angina pectoris, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease,
Symptomatic congestive heart failure of New York Heart Association class III or IV,
Active (acute or chronic) or uncontrolled severe infection (not responding to antibiotics), liver diseases such as cirrhosis and decompensated liver disease,
Known severely impaired lung function (spirometry and diffusion capacity of the lung for carbon monoxide \[DLCO\] 50% or less of normal and oxygen \[O2\] saturation 88% or less at rest on room air), or
Active, bleeding diathesis
Other malignancies within the past 3 years except for basal or squamous cell carcinoma of the skin
Active (acute or chronic) or uncontrolled severe infections (not responding to antibiotics), including acute pelvic inflammatory disease
Congenital or acquired uterine anomaly which distorts the uterine cavity
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use one additional highly effective method of contraception in addition to the LNG-IUD during the study and 8 weeks after. Acceptable highly effective contraception methods include a combination of any of the following:
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;
Total abstinence or;
Male sterilization;
Female bilateral tubal ligation or bilateral salpingectomy Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy or tubal ligation at least six weeks prior to study initiation. When the diagnosis of menopause is unclear based on patient history, we will assess follicle-stimulating hormone \\ (FSH) levels for confirmation. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential
Tirzepatide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with multiple endocrine neoplasia (MEN) 2A or 2B. Such women will be excluded
Participants taking any other prescription medication intended to induce weight loss (i.e., orlistat, phentermine-topiramate, naltrexone-bupropion). A 28-day washout period is required if such women want to enter the study
Participants on active intermittent fasting
Participants currently using insulin for glucose control
Participants who have previously used any glucagon-like peptide (GLP) medications (liraglutide, semaglutide, dulaglutide, exenatide), whether oral or injectable
Participants diagnosed with Lynch Syndrome
What this trial measures
- Weighted pathological complete response (pCR)At 26 weeks
Proportion of pCR at 26 weeks among patients receiving combined treatment with tirzepatide and levonorgestrel intrauterine device (LNG-IUD) compared to historical controls who received LNG-IUD alone.