Endometrial CancerEarly Phase 1NCT07065552
Tirzepatide in Obesity-Driven Endometrial Cancer
A Early Phase 1 study testing Tirzepatide in people with Endometrial Cancer and Obesity, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
LCCC2415 examines the antiproliferative effect of tirzepatide on the endometrium of endometrial cancer (EC). This is a pre-operative window clinical study. Endometrial biopsy samples from patients before tirzepatide treatment will be compared to their post-intervention hysterectomy specimens. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Obesity
- 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2026to Jul 2028
- Phase
- Early Phase 1
- 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
- Current diagnosis of endometrioid histology cancer and scheduled to undergo hysterectomy and staging.
- Agree to comply with all required study assessments and visits including internet capabilities.
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Age ≥ 18 at the time of consent.
- Body mass index of ≥30 kg/m2.
- Presumed clinically early-stage disease (disease confined to uterus only).
- ECOG ≤ 2 or Karnofsky Performance Status of > 50
Who cannot join
- Active infection requiring systemic therapy.
- Subject is pregnant or breast feeding.
- Taking any prescription medications or other drugs that may influence metabolism per discretion of investigator.
- Taking a central nervous system stimulant.
- Current psychological conditions that would be incompatible with participation in this study, as determined by investigator.
- 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 receiving treatment with insulin.
- Have a history of severe hypoglycemia or not be able to communicate an understanding of hypoglycemic symptoms.
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, 1 recruiting
- Recruiting
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Victoria Bae-Jump, M.D., PhD, 919-966-5996, victoria_baejump@med.unc.edu
Victoria Bae-Jump, M.D., PhD
About this study
Official title: A Pre-Operative Window Study of Tirzepatide in Obesity-Driven Endometrial Cancer
LCCC2415 examines the antiproliferative effect of tirzepatide on the endometrium of endometrial cancer (EC). This is a pre-operative window clinical study. Endometrial biopsy samples from patients before tirzepatide treatment will be compared to their post-intervention hysterectomy specimens. If archival tissue is unavailable, a fresh biopsy will be taken before tirzepatide treatment. Post-intervention tissue will be collected from the hysterectomy specimen.
The hypothesis is that tirzepatide's anti-tumorigenic effects are due to both an improvement in the host's metabolic milieu (indirect effect) and a direct effect on the EC tumor microenvironment via the inter-related pathways of insulin, lipid, and mTOR signaling. Therefore, tirzepatide may be an innovative approach to effectively induce weight loss and inhibit tumor growth in EC, the most obesity-driven of all cancers.
Read the detailed description
The primary objective is to determine if tirzepatide decreases proliferation in the tumors of EC patients. The effect of tirzepatide on the endometrium of 20 obese women with EC will be evaluated by comparing each patient's endometrial biopsy before tirzepatide treatment to their post-treatment hysterectomy specimen, through a pre- operative window study. These women will begin tirzepatide treatment for 4 weeks prior to standard-of-care (SOC) surgery. Subjects will have a single end-of-treatment visit 4 weeks after completing therapy and will be followed for 24 months via medical record abstraction to monitor weight loss maintenance.
- Conditions
- Endometrial Cancer, Obesity
- Being tested
- Tirzepatide
- Keywords
- tirzepatide, tumor microenvironment, insulin, lipid, mTOR signaling
- Medical subject headings
- Endometrial Neoplasms, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Tirzepatide will be administered once weekly, subcutaneously, and patients will be taught how to administer this drug at home. Patients will be started on a dose of 5 mg tirzepatide weekly for four weeks prior to surgical staging. .
| Study group | Role | What they receive |
|---|---|---|
| endometrial carcinoma | Experimental | Obese women with endometrial carcinoma are included. Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Proliferation
Change in Proliferation will be determined by immunohistochemical ( Ki-67 staining) analysis pre- (baseline) and post-tirzepatide treatment hysterectomy samples (at the time of surgery and end of treatment). The percentage of tumor cells that are positive for Ki-67, indicating they are in the active phases of the cell cycle (not resting). Low Ki-67 (<10-15%): Slower-growing tumor. Intermediate (15-30%): Moderately proliferative. High (>30%): Fast-growing, potentially more aggressive.
Measured: Baseline - Up to 6 weeks
Secondary outcomes (13)
Improvement in Diabetes
Diabetes status (yes/no) will be documented before and after tirzepatide treatment using the medical records and diabetes diagnostic criteria.
Measured: Baseline - Up to 6 weeks
Improvement in HgbA1C level
HgbA1C level will be documented pre- and post-tirzepatide treatment.
Measured: Baseline - Up to 6 weeks
Improvement in waist-to-hip ratio
The waist-to-hip ratio will be documented pre- and post-tirzepatide treatment.
Measured: Baseline - Up to 6 weeks
Improvement in Body Mass Index
Body Mass Index (measured by dividing weight in kgs by height in meters) will be documented pre- and post-tirzepatide treatment.
Measured: Baseline - Up to 6 weeks
Change in circulating levels of inflammatory cytokines
Serum levels of leptin, adiponectin, CRP, IL-1B, VEGFA, CCL3, IL-23, TNF-A, IL-6 pre- and post-tirzepatide treatment will be documented.
Measured: Baseline - Up to 6 weeks
Change in sex hormones
Serum levels of estradiol, estrone, and sex hormone binding globulin pre- and post-tirzepatide treatment will be documented.
Measured: Baseline - Up to 6 weeks
Change in Lipids
Serum levels of lipid panel pre- and post-tirzepatide treatment will be documented.
Measured: Baseline - Up to 6 weeks
Change in insulin
Serum levels of fasting insulin pre- and post-tirzepatide treatment will be documented.
Measured: Baseline - Up to 6 weeks
Change in Insulin-like Growth Factor 1
Serum levels of Insulin-like Growth Factor 1 (IGF-1 ) pre- and post-tirzepatide treatment will be documented. IGF-1 is a hormone similar in structure to insulin and plays a crucial role in growth and development. Here are the key points about IGF-1:
Measured: Baseline - Up to 6 weeks
Change in glucose
Serum glucose levels pre- and post-tirzepatide treatment will be documented.
Measured: Baseline - Up to 6 weeks
Change in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma-Glutamyl Transferase (GGT) levels
Serum liver function panel pre- and post-tirzepatide treatment will be documented. The same serum sample will be used to measure to determine Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma-Glutamyl Transferase (GGT) levels. All participants will be analyzed using this single sample, and results will be reported in Units per Liter (U/L) for each enzyme.
Measured: Baseline - Up to 6 weeks
Change in Apoptosis
Apoptosis will be assessed via immunohistochemistry before and after tirzepatide treatment.
Measured: Baseline - Up to 6 weeks
Change in metabolic and immune pathways Change in Ribonucleic Acid (RNA) sequence
Metabolic and immune gene expression pathways will be assessed by RNA sequencing in endometrial carcinoma specimen before and after tirzepatide treatment.
Measured: Baseline - Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start27 Apr 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Bae-Jump Victoria, MD PhD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065552
- Sponsor's protocol ID
- LCCC2415
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2025
- Last updated
- 2 Oct 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-Operative Window Study of Tirzepatide in Obesity-Driven Endometrial Cancer
- ClinicalTrials.gov ID
- NCT07065552
- Acronym / sponsor ID
- LCCC2415
- Conditions
- Endometrial Cancer, Obesity
- Keywords
- tirzepatide, tumor microenvironment, insulin, lipid, mTOR signaling
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 15 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.
LCCC2415 examines the antiproliferative effect of tirzepatide on the endometrium of endometrial cancer (EC). This is a pre-operative window clinical study. Endometrial biopsy samples from patients before tirzepatide treatment will be compared to their post-intervention hysterectomy specimens. If archival tissue is unavailable, a fresh biopsy will be taken before tirzepatide treatment. Post-intervention tissue will be collected from the hysterectomy specimen.
The hypothesis is that tirzepatide's anti-tumorigenic effects are due to both an improvement in the host's metabolic milieu (indirect effect) and a direct effect on the EC tumor microenvironment via the inter-related pathways of insulin, lipid, and mTOR signaling. Therefore, tirzepatide may be an innovative approach to effectively induce weight loss and inhibit tumor growth in EC, the most obesity-driven of all cancers.
Detailed description
The primary objective is to determine if tirzepatide decreases proliferation in the tumors of EC patients. The effect of tirzepatide on the endometrium of 20 obese women with EC will be evaluated by comparing each patient's endometrial biopsy before tirzepatide treatment to their post-treatment hysterectomy specimen, through a pre- operative window study. These women will begin tirzepatide treatment for 4 weeks prior to standard-of-care (SOC) surgery. Subjects will have a single end-of-treatment visit 4 weeks after completing therapy and will be followed for 24 months via medical record abstraction to monitor weight loss maintenance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endometrial carcinoma | Experimental | Drug: TirzepatideObese women with endometrial carcinoma are included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Current diagnosis of endometrioid histology cancer and scheduled to undergo hysterectomy and staging.
- Agree to comply with all required study assessments and visits including internet capabilities.
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Age ≥ 18 at the time of consent.
- Body mass index of ≥30 kg/m2.
Key exclusion criteria (8 listed)
- Active infection requiring systemic therapy.
- Subject is pregnant or breast feeding.
- Taking any prescription medications or other drugs that may influence metabolism per discretion of investigator.
- Taking a central nervous system stimulant.
- Current psychological conditions that would be incompatible with participation in this study, as determined by investigator.
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 |
|---|---|---|
| TirzepatideTirzepatide will be administered once weekly, subcutaneously, and patients will be taught how to administer this drug at home. Patients will be started on a dose of 5 mg tirzepatide weekly for four weeks prior to surgical staging. . | Drug | endometrial carcinoma |
Primary outcome
Change in Proliferation
Time frame: Baseline - Up to 6 weeks
Change in Proliferation will be determined by immunohistochemical ( Ki-67 staining) analysis pre- (baseline) and post-tirzepatide treatment hysterectomy samples (at the time of surgery and end of treatment). The percentage of tumor cells that are positive for Ki-67, indicating they are in the active phases of the cell cycle (not resting). Low Ki-67 (<10-15%): Slower-growing tumor. Intermediate (15-30%): Moderately proliferative. High (>30%): Fast-growing, potentially more aggressive.
13 secondary outcomes
Improvement in Diabetes
Time frame: Baseline - Up to 6 weeks
Improvement in HgbA1C level
Time frame: Baseline - Up to 6 weeks
Improvement in waist-to-hip ratio
Time frame: Baseline - Up to 6 weeks
Improvement in Body Mass Index
Time frame: Baseline - Up to 6 weeks
Change in circulating levels of inflammatory cytokines
Time frame: Baseline - Up to 6 weeks
Change in sex hormones
Time frame: Baseline - Up to 6 weeks
Change in Lipids
Time frame: Baseline - Up to 6 weeks
Change in insulin
Time frame: Baseline - Up to 6 weeks
Change in Insulin-like Growth Factor 1
Time frame: Baseline - Up to 6 weeks
Change in glucose
Time frame: Baseline - Up to 6 weeks
Change in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma-Glutamyl Transferase (GGT) levels
Time frame: Baseline - Up to 6 weeks
Change in Apoptosis
Time frame: Baseline - Up to 6 weeks
Change in metabolic and immune pathways Change in Ribonucleic Acid (RNA) sequence
Time frame: Baseline - Up to 6 weeks
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 2 Oct 2026.
- UNC Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
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.
Bae-Jump Victoria, MD PhD 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 Early Phase 1 study testing Tirzepatide in people with Endometrial Cancer and Obesity, 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 2 Oct 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Luz Cuaboy (+1 919-966-4432, luz_cuaboy@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Proliferation (time frame: Baseline - Up to 6 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 2 Oct 2026.