Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Low-grade Cancer of the Endometrium
- Status
- Not yet recruitingResults none
- Why it is watched
- non-weight indication: cancer
- Who it enrolls
- age 18 Years to 41 Years; female; BMI ≥27 required; conditions: Endometrial Cancer; Atypical Hyperplasia
- Interventions
- Mounjaro; Mirena
- Conditions
- Endometrial Cancer; Atypical Hyperplasia
- Phase and size
- Phase 2 · 71 participants
- Dates
- Start 2025-08
Primary completion 2027-02 - Sponsor
- University Health Network, Toronto (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Assessment of Complete Pathologic Response48 weeks
02Eligibility
Who can take part
Inclusion Criteria: * BMI ≥ 27 * Diagnosis of grade 1 or 2 endometrioid endometrial cancer or atypical hyperplasia made by either endometrial biopsy or dilation and curettage * For those with endometrial cancer, clinical FIGO 2009 stage 1A disease without evidence of metastatic disease beyond the uterus and no myometrial invasion by MRI or CT * ECOG status \<2 * Desire for fertility preservation * Ability to understand and willing to sign a written informed consent document Exclusion Criteria: * Evidence of myometrial invasion or extra-uterine disease on imaging * High grade or p53 mutated (p53mut) endometrial cancer * Estrogen receptor negative endometrial cancer (positivity defined as moderate/strong staining\>10%) * Mismatch repair deficient (MMRd) endometrial cancer * History of other malignancies except if curatively treated with no evidence of disease for \>5 years * Previous surgical treatment of obesity * Current use of weight loss medication (no use in last 2 months) * Medical co-morbidity with end-organ dysfunction * Contraindications to pIUD or tirzepatide. * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
03Change log
Registry changes
No changes recorded since the trial was added.