Endometrial CancerPhase 2NCT07078838
Tirzepatide in Women With Obesity and Endometrial Intra-epithelial Neoplasia or Grade 1 Endometrial Cancer
A Phase 2 study testing Tirzepatide in people with Endometrial Cancer and Endometrial Intraepithelial Neoplasia, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The goal of this study is to determine the anti-proliferative effect of tirzepatide on the endometrium of patients with endometrial intra-epithelial neoplasia (EIN) and Grade 1 endometrial cancer (EC), by comparing archival endometrial biopsy samples of patients randomized to tirzepatide versus SOC (no tirzepatide) to… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Endometrial Intraepithelial Neoplasia, Grade 1 Endometrial Endometrioid Carcinoma
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Mar 2029
- 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
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- The subject is willing and able to comply with study procedures based on the judgement of the investigator.
- Age > 18 years at the time of consent.
- ECOG ≤ 2 or Karnofsky Performance Status of >50
- Histological or cytological evidence/confirmation of endometrial intraepithelial neoplasia (EIN) or grade 1 endometrioid histology endometrial cancer (EC) and scheduled to undergo standard of care hysterectomy and staging.
- Subject must have archival EC tissue available.
- Body mass index of >30kg/m2
- Demonstrate adequate organ function as defined in the protocol, all screening labs to be obtained within 28 days prior to initiating study treatment
Who cannot join
- Active infection requires systemic therapy.
- Subject is pregnant or breast breastfeeding, or planning to become pregnant at any time during the study
- Taking any prescription medications or other drugs that influence weight change in the past 3 months.
- Known sensitivities (i.e., urticaria and eczema) to GIP and GLP-1 receptor agonists.
- Have type 1 diabetes mellitus or latent autoimmune diabetes in adults, or are receiving treatment with insulin.
- Have a history of severe hypoglycemia or not be able to communicate an understanding of hypoglycemic symptoms.
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- Have a history of acute or chronic pancreatitis or serum lipase/amylase >2X ULN or fasting triglyceride >500 mg/dL at screening.
- Have a diagnosis of gastroparesis, history of bariatric surgery, or a clinically significant gastric emptying abnormality.
- Have a history or family history of multiple endocrine neoplasia, thyroid C-cell hyperplasia, or medullary thyroid carcinoma.
- Currently receiving another treatment for EIN or EC.
- Any condition, in the opinion of the investigator, which would prohibit safe participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
About this study
Official title: A Randomized, Window of Opportunity Trial of Tirzepatide in Women With Obesity and a Diagnosis of Endometrial Intra-epithelial Neoplasia (EIN) or Grade 1 Endometrial Cancer
The goal of this study is to determine the anti-proliferative effect of tirzepatide on the endometrium of patients with endometrial intra-epithelial neoplasia (EIN) and Grade 1 endometrial cancer (EC), by comparing archival endometrial biopsy samples of patients randomized to tirzepatide versus SOC (no tirzepatide) to their post-intervention hysterectomy specimens.
It was hypothesized that tirzepatide may help fight tumors in two ways: indirectly, by improving the body's overall metabolic health, and directly, by acting on abnormal cells in the uterus, such as those found in endometrial intraepithelial neoplasia (EIN) and endometrial cancer (EC). EIN is considered a precursor to EC. Tirzepatide may influence the tumor environment through key biological pathways related to insulin, fat metabolism, and mTOR signaling, all of which are often disrupted in individuals with obesity. Because both EIN and EC are strongly linked to obesity, tirzepatide could offer a promising dual benefit, promoting weight loss while also slowing or stopping tumor growth. The primary goal of this study is to determine whether tirzepatide can reduce cell proliferation in the lesions or tumors of patients with EIN and early- stage (Grade 1) EC.
Read more
Patients will either be randomized to receive tirzepatide or no tirzepatide for 4 weeks prior to their hysterectomy surgery. Patients randomized to the tirzepatide arm will be given a glucose monitoring system for continuous monitoring with real-time alarms to alert of hypoglycemia. Patients will complete diaries during treatment to document compliance with medication and record any side effects.
Patients will undergo standard of care surgery 7-10 days after the final dose of tirzepatide in order to minimize the risk of gastroparesis. During surgery (hysterectomy), an endometrial biopsy for uterine biopsy tissue will be collected.
At the 1-month post-operation visit, patients from both arms will be referred to an institutional weight loss clinic.
- Conditions
- Endometrial Cancer, Endometrial Intraepithelial Neoplasia, Grade 1 Endometrial Endometrioid Carcinoma
- Being tested
- Tirzepatide
- Keywords
- tirzepatide, obesity, tumor environment, cell proliferation
- Medical subject headings
- Endometrial Neoplasms, Endometrial Hyperplasia, Obesity, Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Patients will receive a subcutaneous dose of 5 mg weekly for the 4 weeks prior to surgical staging.
| Study group | Role | What they receive |
|---|---|---|
| tirzepatide | Experimental | The treatment arm will receive 5mg tirzepatide for 4 weeks prior to standard of care surgery. Receives: Drug: Tirzepatide |
| No tirzepatide | No intervention | No tirzepatide arm will not receive tirzepatide, and Standard Operating Procedures will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-proliferative effect of Tirzepatide
Anti-proliferative effect of Tirzepatide will be measured via Immunohistochemistry analysis using multi-color fluorescence assays to assess Ki-67 staining.
Measured: At 4th week (during surgery)
Secondary outcomes (2)
The Ki-67/caspase-3 ratio change
The Ki-67/caspase-3 ratio will be assessed via immunohistochemistry, before and after treatment in the 2 groups. It is expected that the ratio will exhibit stronger intervention effects since proliferation should decrease and apoptosis should increase.
Measured: At 4th week (during surgery)
Response to treatment
Response to treatment will be defined as a decrease of ≥13% in proliferation of the endometrium (EIN and EC) from pre- to post-treatment.
Measured: At 4th week (during surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study startJan 2027 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Victoria Bae-Jump, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078838
- Sponsor's protocol ID
- LCCC2502
- Other IDs
- U01CA281026
- Status last verified
- Sep 2026
- First submitted
- 12 Jul 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Window of Opportunity Trial of Tirzepatide in Women With Obesity and a Diagnosis of Endometrial Intra-epithelial Neoplasia (EIN) or Grade 1 Endometrial Cancer
- ClinicalTrials.gov ID
- NCT07078838
- Acronym / sponsor ID
- LCCC2502
- Conditions
- Endometrial Cancer, Endometrial Intraepithelial Neoplasia, Grade 1 Endometrial Endometrioid Carcinoma
- Keywords
- tirzepatide, obesity, tumor environment, cell proliferation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 22 Jul 2025 (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.
The goal of this study is to determine the anti-proliferative effect of tirzepatide on the endometrium of patients with endometrial intra-epithelial neoplasia (EIN) and Grade 1 endometrial cancer (EC), by comparing archival endometrial biopsy samples of patients randomized to tirzepatide versus SOC (no tirzepatide) to their post-intervention hysterectomy specimens.
It was hypothesized that tirzepatide may help fight tumors in two ways: indirectly, by improving the body's overall metabolic health, and directly, by acting on abnormal cells in the uterus, such as those found in endometrial intraepithelial neoplasia (EIN) and endometrial cancer (EC). EIN is considered a precursor to EC. Tirzepatide may influence the tumor environment through key biological pathways related to insulin, fat metabolism, and mTOR signaling, all of which are often disrupted in individuals with obesity. Because both EIN and EC are strongly linked to obesity, tirzepatide could offer a promising dual benefit, promoting weight loss while also slowing or stopping tumor growth. The primary goal of this study is to determine whether tirzepatide can reduce cell proliferation in the lesions or tumors of patients with EIN and early- stage (Grade 1) EC.
Patients will either be randomized to receive tirzepatide or no tirzepatide for 4 weeks prior to their hysterectomy surgery. Patients randomized to the tirzepatide arm will be given a glucose monitoring system for continuous monitoring with real-time alarms to alert of hypoglycemia. Patients will complete diaries during treatment to document compliance with medication and record any side effects.
Patients will undergo standard of care surgery 7-10 days after the final dose of tirzepatide in order to minimize the risk of gastroparesis. During surgery (hysterectomy), an endometrial biopsy for uterine biopsy tissue will be collected.
At the 1-month post-operation visit, patients from both arms will be referred to an institutional weight loss clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tirzepatide | Experimental | Drug: TirzepatideThe treatment arm will receive 5mg tirzepatide for 4 weeks prior to standard of care surgery. |
| No tirzepatide | No intervention | –No tirzepatide arm will not receive tirzepatide, and Standard Operating Procedures will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- The subject is willing and able to comply with study procedures based on the judgement of the investigator.
- Age > 18 years at the time of consent.
- ECOG ≤ 2 or Karnofsky Performance Status of >50
- Histological or cytological evidence/confirmation of endometrial intraepithelial neoplasia (EIN) or grade 1 endometrioid histology endometrial cancer (EC) and scheduled to undergo standard of care hysterectomy and staging.
Key exclusion criteria (11 listed)
- Active infection requires systemic therapy.
- Subject is pregnant or breast breastfeeding, or planning to become pregnant at any time during the study
- Taking any prescription medications or other drugs that influence weight change in the past 3 months.
- Known sensitivities (i.e., urticaria and eczema) to GIP and GLP-1 receptor agonists.
- Have type 1 diabetes mellitus or latent autoimmune diabetes in adults, or are receiving treatment with insulin.
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 |
|---|---|---|
| TirzepatidePatients will receive a subcutaneous dose of 5 mg weekly for the 4 weeks prior to surgical staging. | Drug | tirzepatide |
Primary outcome
Anti-proliferative effect of Tirzepatide
Time frame: At 4th week (during surgery)
Anti-proliferative effect of Tirzepatide will be measured via Immunohistochemistry analysis using multi-color fluorescence assays to assess Ki-67 staining.
2 secondary outcomes
The Ki-67/caspase-3 ratio change
Time frame: At 4th week (during surgery)
Response to treatment
Time frame: At 4th week (during surgery)
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 28 Sep 2026.
- UNC Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
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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.
Victoria Bae-Jump principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tirzepatide in people with Endometrial Cancer and Endometrial Intraepithelial Neoplasia, run by UNC Lineberger Comprehensive Cancer Center at 1 site 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 8 inclusion and 11 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 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Chelsea Baker ((919)-843-5230, chelsea_baker@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-proliferative effect of Tirzepatide (time frame: At 4th week (during surgery)). 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 28 Sep 2026.