Tirzepatide for obesity-related endometrial cancer
A Pre-Operative Window Study of Tirzepatide in Obesity-Driven Endometrial Cancer
This study will test whether four weeks of tirzepatide before surgery reduces tumor cell growth in obese women with endometrial cancer.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT07065552 on ClinicalTrials.gov |
What this trial studies
This is a pre-operative window study in which 20 obese women with presumed early-stage endometrioid endometrial cancer will receive tirzepatide for four weeks prior to their scheduled hysterectomy. Each patient's diagnostic endometrial biopsy (or archival tissue) will be compared to the hysterectomy specimen to measure changes in tumor proliferation and tumor microenvironment markers. The trial examines both indirect metabolic effects (weight loss, insulin and lipid changes) and possible direct effects on mTOR and related signaling within tumor tissue. Subjects will have an end-of-treatment visit and will be followed via medical record abstraction for 24 months to monitor weight maintenance.
Who should consider this trial
Good fit: Adults (≥18) with presumed early-stage endometrioid endometrial cancer who are obese (BMI ≥30), scheduled for hysterectomy, and with ECOG ≤2 are the ideal candidates.
Not a fit: Patients with advanced or non-endometrioid disease, pregnant or breastfeeding individuals, those taking medications that affect metabolism, or with active infections or relevant drug sensitivities are unlikely to benefit or to be eligible.
Why it matters
Potential benefit: If successful, tirzepatide could produce weight loss and reduce tumor proliferation, potentially improving surgical outcomes and longer-term prognosis for obese patients with endometrial cancer.
How similar studies have performed: GIP/GLP-1 receptor agonists like tirzepatide have produced substantial weight loss in diabetes and obesity trials, but direct anti-tumor effects in endometrial cancer are largely untested in humans and mostly supported by preclinical or indirect metabolic data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chapel Hill, North Carolina
- Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Bae-Jump Victoria, MD PhD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Luz Cuaboy
- Email: luz_cuaboy@med.unc.edu
- Phone: +1 919-966-4432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.