Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial NeoplasiaPhase 2NCT07349641
A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer
A Phase 2 study testing Medical Device Usage and Evaluation and Tirzepatide in people with Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia and FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, run by National Cancer Institute (NCI) at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia, FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
- What is being tested?
- Medical Device Usage and Evaluation and Tirzepatide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Nov 2026to 31 Oct 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Northwestern University
Chicago, Illinois, 60611
Jenna Z. Marcus, 312-472-4177, jenna.marcus@nm.org
Jenna Z. Marcus
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967
Alexandra S. Bercow, 832-628-6771, asbercow@mdanderson.org
Alexandra S. Bercow
UT MD Anderson Cancer Center
Houston, Texas, 77030
Roni N. Wilke, 713-822-4502, RNitecki@mdanderson.org
Roni N. Wilke
About this study
Official title: Tirzepatide With Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer in Overweight and Obese Women
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the proportion of pathological complete response (pCR) on endometrial biopsy (EMB) at 26 weeks among patients receiving combined treatment with tirzepatide (dosed weekly) and levonorgestrel intrauterine device (LNG-IUD) for management of endometrial atypical hyperplasia/endometrial intraepithelial neoplasia (AH/EIN) and grade 1 endometrioid endometrial cancer in overweight or obese women compared to historical controls who received LNG-IUD alone.
SECONDARY OBJECTIVES:
- To determine the proportion of participants who achieve sustained pathologic complete response on EMB at 52 weeks (12 months) compared to historical controls.
II. To estimate the time to complete response and duration of response, up to 52 weeks (12 months) compared to historical controls.
III. To determine the rate of hyperplasia persistence and progression to endometrial cancer at 26 and 52 weeks (6 and 12 months) compared to historical controls.
IV. To estimate percent change in cell proliferation (Ki-67+) at 12, 26, 39 and 52 weeks compared to historical controls and baseline.
- To estimate percent change in hemoglobin A1C (HbA1C) at 12, 26, 39 and 52 weeks compared to baseline.
VI. To estimate percent weight change every 4 weeks up to week 20 and then at weeks 26, 39 and 52 compared to baseline.
VII. To estimate percent change in fasting blood glucose every 4 weeks up to week 20 and then at weeks 26, 39, and 52 compared to baseline.
EXPLORATORY OBJECTIVES:
- To investigate the effect of GLP-1 agonism on the endometrial immune microenvironment at 12, 26, 39 and 52 weeks compared to baseline.
II. To investigate the effect of GLP-1 agonism on systemic inflammation and metabolic markers at 12 26, 39 and 52 weeks compared to baseline.
III. To investigate weight independent effects of GLP-1 agonism on cell proliferation (Ki-67+) at 12, 26, 39 and 52 weeks compared to baseline.
IV. To investigate the effect of tirzepatide and LNG-IUD on treatment response based on molecular ProMisE (Proactive Molecular Risk Classifier for Endometrial Cancer) classification at 26 and 52 weeks.
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. Patients who qualify for tirzepatide or another weight loss medication as determined by primary provider may continue to receive treatment beyond 26 weeks as per standard of care.
After completion of study treatment, patients are followed up at weeks 30, 39, and 52.
- Conditions
- Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia, FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
- Being tested
- Medical Device Usage and Evaluation, Tirzepatide
- Medical subject headings
- Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Device Usage and EvaluationOther
Undergo LNG-IUD placement
TirzepatideDrug
Given SC
| Study group | Role | What they receive |
|---|---|---|
| Prevention (LNG-IUD, tirzepatide) | Experimental | After LNG-IUD placement at baseline or on day 0, participants then self-inject tirzepatide SC QW for 26 weeks in the absence of disease progression or unacceptable toxicity. Patients who qualify for tirzepatide or another weight loss medication as determined by primary provider may continue to receive treatment beyond 26 weeks as per standard of care. Receives: Other: Medical Device Usage and Evaluation; Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weighted pathological complete response (pCR)
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.
Measured: At 26 weeks
Secondary outcomes (7)
Proportion of participants who achieve pCR on endometrial biopsy
Will be compared to historical controls.
Measured: At 52 weeks
Time to complete response and duration of response
Will be compared to historical controls.
Measured: Up to 52 weeks
Rate of hyperplasia persistence and progression to EC
Will be compared to historical controls as assessed by standard pathologic criteria.
Measured: At 26 and 52 weeks
Percent change in cell proliferation
Will assess Ki67 within pre-treatment biopsy and post-treatment biopsies. Will also compare with historical controls.
Measured: At baseline and 12, 26, 39, and 52 weeks
Percent change in hemoglobin A1C
Will be measured by means of commercially available assays.
Measured: At baseline and weeks 12, 26, 39, and 52
Percent weight change
Will summarize percent changes from baseline.
Measured: Every 4 weeks up to week 20 and at weeks 26, 39, and 52
Percent change in fasting blood glucose
Will summarize percent changes from baseline.
Measured: Every 4 weeks up to week 20 and at weeks 26, 39, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Roni N Wilke, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349641
- Sponsor's protocol ID
- NCI-2026-00081
- Other IDs
- NCI-2026-00081, MDA24-19-01, MDA24-19-01, P30CA016672, UG1CA242609
- Status last verified
- Aug 2026
- First submitted
- 16 Jan 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tirzepatide With Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer in Overweight and Obese Women
- ClinicalTrials.gov ID
- NCT07349641
- Acronym / sponsor ID
- NCI-2026-00081
- Conditions
- Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia, FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To determine the proportion of pathological complete response (pCR) on endometrial biopsy (EMB) at 26 weeks among patients receiving combined treatment with tirzepatide (dosed weekly) and levonorgestrel intrauterine device (LNG-IUD) for management of endometrial atypical hyperplasia/endometrial intraepithelial neoplasia (AH/EIN) and grade 1 endometrioid endometrial cancer in overweight or obese women compared to historical controls who received LNG-IUD alone.
SECONDARY OBJECTIVES:
- To determine the proportion of participants who achieve sustained pathologic complete response on EMB at 52 weeks (12 months) compared to historical controls.
II. To estimate the time to complete response and duration of response, up to 52 weeks (12 months) compared to historical controls.
III. To determine the rate of hyperplasia persistence and progression to endometrial cancer at 26 and 52 weeks (6 and 12 months) compared to historical controls.
IV. To estimate percent change in cell proliferation (Ki-67+) at 12, 26, 39 and 52 weeks compared to historical controls and baseline.
- To estimate percent change in hemoglobin A1C (HbA1C) at 12, 26, 39 and 52 weeks compared to baseline.
VI. To estimate percent weight change every 4 weeks up to week 20 and then at weeks 26, 39 and 52 compared to baseline.
VII. To estimate percent change in fasting blood glucose every 4 weeks up to week 20 and then at weeks 26, 39, and 52 compared to baseline.
EXPLORATORY OBJECTIVES:
- To investigate the effect of GLP-1 agonism on the endometrial immune microenvironment at 12, 26, 39 and 52 weeks compared to baseline.
II. To investigate the effect of GLP-1 agonism on systemic inflammation and metabolic markers at 12 26, 39 and 52 weeks compared to baseline.
III. To investigate weight independent effects of GLP-1 agonism on cell proliferation (Ki-67+) at 12, 26, 39 and 52 weeks compared to baseline.
IV. To investigate the effect of tirzepatide and LNG-IUD on treatment response based on molecular ProMisE (Proactive Molecular Risk Classifier for Endometrial Cancer) classification at 26 and 52 weeks.
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. Patients who qualify for tirzepatide or another weight loss medication as determined by primary provider may continue to receive treatment beyond 26 weeks as per standard of care.
After completion of study treatment, patients are followed up at weeks 30, 39, and 52.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (LNG-IUD, tirzepatide) | Experimental | Other: Medical Device Usage and Evaluation, Drug: TirzepatideAfter LNG-IUD placement at baseline or on day 0, participants then self-inject tirzepatide SC QW for 26 weeks in the absence of disease progression or unacceptable toxicity. Patients who qualify for tirzepatide or another weight loss medication as determined by primary provider may continue to receive treatment beyond 26 weeks as per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Device Usage and EvaluationUndergo LNG-IUD placement | Other | Prevention (LNG-IUD, tirzepatide) |
| TirzepatideGiven SC | Drug | Prevention (LNG-IUD, tirzepatide) |
Primary outcome
Weighted pathological complete response (pCR)
Time frame: 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.
7 secondary outcomes
Proportion of participants who achieve pCR on endometrial biopsy
Time frame: At 52 weeks
Time to complete response and duration of response
Time frame: Up to 52 weeks
Rate of hyperplasia persistence and progression to EC
Time frame: At 26 and 52 weeks
Percent change in cell proliferation
Time frame: At baseline and 12, 26, 39, and 52 weeks
Percent change in hemoglobin A1C
Time frame: At baseline and weeks 12, 26, 39, and 52
Percent weight change
Time frame: Every 4 weeks up to week 20 and at weeks 26, 39, and 52
Percent change in fasting blood glucose
Time frame: Every 4 weeks up to week 20 and at weeks 26, 39, and 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Yes. NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roni N Wilke principal investigator
M.D. Anderson Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Medical Device Usage and Evaluation and Tirzepatide in people with Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia and FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, run by National Cancer Institute (NCI) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weighted pathological complete response (pCR) (time frame: At 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.