NCT07065552RecruitingEarly phase 1
Tirzepatide in Obesity-Driven Endometrial Cancer
A Pre-Operative Window Study of Tirzepatide in Obesity-Driven Endometrial Cancer
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 4 Jun 2025
- Start date
- 27 Apr 2026
- Primary completion date
- Jul 2028
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Obesity, Endometrial cancer
- NCT number
- NCT07065552
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 20
- From 27 Apr 2026 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking any prescription medications or other drugs that may influence metabolism per discretion of investigator.
- Have type 1 diabetes mellitus or latent autoimmune diabetes in adults or receiving treatment with insulin.
Other illness
- Active infection requiring systemic therapy.
- Current psychological conditions that would be incompatible with participation in this study, as determined by investigator.
- Have a history of severe hypoglycemia or not be able to communicate an understanding of hypoglycemic symptoms.
Other
- Subject is pregnant or breast feeding.
- Taking a central nervous system stimulant.
- Known sensitivities (i.e., urticaria and eczema) to GIP and GLP-1 receptor agonists.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.