Not yet recruitingPhase 2

A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer

Tirzepatide With Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer in Overweight and Obese Women

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 52 weeks, 26 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To estimate the time to complete response and duration of response, up to 52 weeks (12 months) compared to historical controls."
  • "OUTLINE: After LNG-IUD placement at baseline or on day 0, participants then self-inject tirzepatide subcutaneously (SC) once a week (QW) for 26 weeks in the absence of disease progression or unacceptable toxicity."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding tirzepatide weight-loss shots to a hormone-releasing IUD helps clear abnormal or cancer cells from the womb lining. It is for adult women who are overweight or obese and have precancer changes or grade 1 womb-lining cancer who want treatment without surgery.

This phase II trial studies whether adding tirzepatide injections to a levonorgestrel intrauterine device (LNG-IUD) improves pathologic response (absence of cancer cells in tissue samples after treatment) in women with endometrial atypical hyperplasia/endometrial intraepithelial neoplasia (AH/EIN) or grade 1 endometrial cancer who are overweight or obese. Endometrial cancer occurrence has continued to rise in the United States. Over half of endometrial cancer cases are thought to be attributable to being overweight and obese, and the risk relationship appears to be weight dependent. AH/EIN is a precancerous condition of the endometrium (the uterus or womb) where the lining of the uterus grows abnormally thick, and the cells become abnormal. Women with this thickening have a higher-than-average risk of developing endometrial cancer if left untreated. The usual approach for patients who have AH/EIN and grade 1 endometrial cancer is the removal of the uterus. While surgical treatment is generally safe and effective, it may not be the best approach for some patients. The LNG-IUD is a small, T-shaped device inserted into the uterus that releases the hormone levonorgestrel, a progestin, which counteracts the effects of estrogen in the endometrium. Tirzepatide is a dual glucagon-like peptide 1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) agonist which has been shown to drive weight loss. Adding tirzepatide injections to LNG-IUD may help overweight or obese women with AH-EIN or grade 1 endometrial cancer lose weight, which may improve pathologic response.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be a woman age 18 or older with precancer changes called AH/EIN or grade 1 endometrioid womb-lining cancer, confirmed by a D&C procedure that collects tissue.
  • Want treatment without surgery. Have a BMI of 30 or higher, or 27 or higher with high blood pressure, type 2 diabetes, or high cholesterol. BMI is a measure of weight compared with height.
  • Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • Be able to have a womb-lining biopsy, which takes a small tissue sample, every 3 months.
  • Understand and agree to sign a consent form in English or Spanish.
  • If you have HIV or hepatitis B, the virus must meet the study's treatment and blood-test rules. Hepatitis C must be cured or under treatment with no virus found in blood tests.
  • Past progesterone use for other conditions is allowed, but usually requires a 28-day break before IUD placement. A suitable stored tissue sample may allow you to skip this break.
  • Oral diabetes medicines, such as metformin, and long-term medicines to control herpes are allowed.

Who can't join

  • Grade 2 or 3 womb-lining cancer, other listed cancer types, cancer outside the womb, or Lynch syndrome, an inherited condition that raises cancer risk.
  • Another cancer within the past 3 years, except basal or squamous cell skin cancer. Other study drugs or cancer treatments are not allowed; prior treatment needs at least a 14-day break.
  • Pregnancy or plans to become pregnant within 6 months after the study ends. Breastfeeding must stop with tirzepatide. Those who can become pregnant must use extra highly effective birth control during the study and for 8 weeks after.
  • Severe or uncontrolled illness, including serious heart, lung, liver, infection, or bleeding problems; or mental health or social problems that prevent following study rules.
  • A womb shape problem that changes its inner space, or an active pelvic infection.
  • Allergy to medicines like the hormone IUD or GLP-1 medicines. A personal or family history of medullary thyroid cancer, or MEN 2A or 2B, which are inherited conditions that can cause tumors.
  • Current insulin use, any past use of GLP medicines such as semaglutide, or other prescription weight-loss drugs without a 28-day break before joining.
  • Current intermittent fasting, meaning planned periods without eating.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with tirzepatide, breastfeeding should be discontinued if the mother is treated with tirzepatide * 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

Study sites (3)

IL

TX