An Early Phase 1 interventional study of Tirzepatide in Grade 1 Endometrial Endometrioid Carcinoma, Endometrial Intraepithelial Neoplasia and Metabolic Comorbidities, sponsored by Milton S. Hershey Medical Center. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Milton S. Hershey Medical Center · Early Phase 1, Interventional, and Treatment
This single-arm study will evaluate the feasibility, safety, and preliminary efficacy of tirzepatide in combination with standard levonorgestrel intrauterine device (LNG-IUD) therapy in patients with endometrial intraepithelial neoplasia (EIN) or grade 1 endometrioid endometrial carcinoma with co-existing obesity and metabolic risk factors. Participants will receive tirzepatide once weekly while continuing standard clinical management with an LNG-IUD. Treatment decisions will remain at the discretion of the treating physician. The primary objective is to evaluate pathologic response at approximately 6 months. Secondary objectives include changes in metabolic parameters, assessing the incidence and severity of adverse events of tirzepatide and LNG-IUD therapy, quality of life assessment, change in weight, and change in BMI.
Endometrial cancer is one of the most common gynecologic malignancies in the United States, with an increasing incidence rate. Obesity has been identified as a major risk factor for endometrial carcinogenesis and is prevalent among patients with endometrial intraepithelial neoplasia (EIN) and early-stage endometrial cancer. Tirzepatide, a dual glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 receptor agonist (GIP/GLP-1 RA), can cause meaningful weight loss and improvement in metabolic parameters. Levonorgestrel intrauterine device (LNG-IUD) therapy is a standard hormonal treatment for local EIN and grade 1 endometrioid endometrial carcinoma. This single-arm, single-center investigator-initiated study will evaluate the feasibility, safety, and preliminary efficacy of combining tirzepatide with standard LNG-IUD treatment in patients with EIN or grade 1 endometrioid endometrial carcinoma with co-existing obesity and metabolic risk factors. Eligible participants will be enrolled after initial histological confirmation of either EIN or grade 1 endometrioid endometrial carcinoma. Clinical management will remain at the discretion of the treating physician.
110 studies on the registry are indexed under Endometrial Hyperplasia; 38 are open to participants now.
This study's planned enrollment of 15 is below the median of 80 across 71 interventional studies indexed under Endometrial Hyperplasia.
Browse Endometrial Hyperplasia studies →Milton S. Hershey Medical Center is the lead sponsor of 492 studies on the registry; 60 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 46 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 ( A1c > 6.0%) d. Diagnosed with sleep apnea
Exclusion
Known or to either:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive tirzepatide in combination with standard clinical management with an LNG-IUD. Tirzepatide will be initiated at 2.5 mg subcutaneously once weekly. Dose escalation will occur according to the study protocol based on participant tolerability and treating physician discretion. Tirzepatide will be administered for approximately 6 months.
Drug: Tirzepatide
Tirzepatide is a dual glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 receptor agonist (GIP/GLP-1 RA) that can promote weight loss and improve metabolic parameters in patients with obesity.
Pathologic Response at 6 months from Cycle 1 Day 1
Pathologic response will be assessed at Cycle 6 Day 28, approximately 6 months after Cycle 1 Day 1, using available clinical pathology specimens, as clinically indicated. For participants undergoing definitive surgical management, pathologic response may be assessed using the hysterectomy specimen. For participants not undergoing hysterectomy, pathologic response may be assessed using an endometrial biopsy or dilation and curettage (D\&C). Pathologic response will be categorized as complete response, partial response, stable disease, or progressive disease.
Time frame: At the end Cycle 6 Day 28 (Approximately 6 months from Cycle 1 Day 1with each cycle approximately 28 days)
Change in metabolic parameters
Hemoglobin A1c and Lipid Profile
Time frame: At Baseline, Cycle 4 Day 1, and Cycle 6 Day 28 (each cycle is approximately 28 days)
Assessing the Incidence and Severity of Adverse Events of Tirzepatide and LNG-IUD therapy
Assess the incidence and severity of adverse events during study treatment, including adverse events considered related to tirzepatide or LNG-IUD therapy, graded according to CTCAE version 5.0 where applicable.
Time frame: Through study completion, an average of 9 months
Quality of Life Assessment Utilizing Study 36-Item Short Form Health Survey (SF-36) Quality of Life Score
Quality of life will be assessed using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). This survey form is a questionnaire, and participants will answer 3-point and 5-point Likert Scale questions as well as yes or no questions. This survey does not provide an aggregated score as it is opinion based. If the survey shows that a patient's quality of life is being impacted due to study treatment, appropriate action will be taken at the discretion of the treating physician.
Time frame: Cycle 1 Day 1, Cycle 4 Day 1, Cycle 6 Day 28, and 3 months from Cycle 6 Day 28
Change in Weight
Participants weight will be collected for approximately 6 months to assess change in weight while using Tirzepatide.
Time frame: For a total of 6 months from Baseline to Cycle 6 Day 28. Weight will be collected at Baseline, Cycle 4 Day 1, Cycle 6 Day 28, and 3 months from Cycle 6 Day 28 (each cycle is approximately 28 days)
Change in BMI
Participants BMI will be collected for approximately 6 months to assess changes in BMI while utilizing Tirzepatide
Time frame: For a total of 6 months from Baseline to Cycle 6 Day 28. Weight will be collected at Baseline, Cycle 4 Day 1, Cycle 6 Day 28, and 3 months from Cycle 6 Day 28 (each cycle is approximately 28 days)
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tirzepatide
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