Clinical trial · Interventional
Tirzepatide in Obesity-Driven Endometrial Cancer
A Pre-Operative Window Study of Tirzepatide in Obesity-Driven Endometrial Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tirzepatide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- endometrial carcinoma
- description
- Obese women with endometrial carcinoma are included.
- interventionNames
- Drug: Tirzepatide
Primary outcomes (1)
- measure
- Change in Proliferation
- timeFrame
- Baseline - Up to 6 weeks
- description
- 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.
Secondary outcomes (13)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available