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NCT07065552 · ClinicalTrials.gov registry record · Early Phase 1
Tirzepatide in Obesity-Driven Endometrial Cancer
A Early Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT07065552: Recruiting Early Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT07065552 is a Early Phase 1 study that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07065552, a Early Phase 1 study, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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.
Interventions
- DRUG Tirzepatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-04-27 |
| Est. Completion | 2028-07 |
| Phase | Early Phase 1 |
What NCT07065552 shows while recruiting
NCT07065552 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Tirzepatide is the first listed.
NCT07065552 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07065552 about?
NCT07065552 is a clinical study titled "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 arc...
What is the current status of trial NCT07065552?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2026-04-27. Estimated completion is 2028-07.
What interventions are being tested in trial NCT07065552?
The interventions under investigation include: Tirzepatide (DRUG).
Who is sponsoring clinical trial NCT07065552?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07065552's enrollment target sits among peer trials
20 1157th of 2000 higher than 710 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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