WE-FiERCE

Not yet recruitingPhase 2

Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Low-grade Cancer of the Endometrium

Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium (WE-FiERCE)

Lead sponsor

University Health Network, Toronto

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Obesity / overweight, Oncology, Reproductive / infertility

Key I/E criteria

•BMI ≥27•Female

Primary endpoint

•Assessment of Complete Pathologic Response

Identifiers

Registered as

NCT IDNCT06073184

Org study ID25-5042

Timeline

Milestones

Study first posted2023-10-10actual

Last update posted2025-06-10actual

Study start2025-08estimated (month precision)

Primary completion2027-02estimated (month precision)

Study completion2032-02estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightOncologyReproductive / infertility

Eligibility

Who can enroll

Minimum age18 Years

Maximum age41 Years

SexFemale

Healthy volunteersNot accepted

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.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Weight & body composition

Patient-reported / QoL

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint/low confidence

Assessment of Metabolic Outcomes

Time frame:48 weeks

descriptive

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint/low confidence

Assessment of Patient Reported Outcomes

Time frame:48 weeks

descriptive, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Assessment of Safety and Tolerability

Time frame:48 weeks

Treatment-emergent AEs (any)

descriptive

Other clinical outcomes

3 endpoints

Primary/protocol endpoint/low confidence

Assessment of Complete Pathologic Response

Time frame:48 weeks

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Assessment of Secondary Oncologic Outcomes

Time frame:6 years

descriptive, event

Secondary/protocol endpoint/low confidence

Assessment of Reproductive Outcomes

Time frame:6 years

composite event, event

componentspregnancy rate, live birth, miscarriage, pregnancy complications

Other (unclassified)

1 endpoint

Secondary/protocol endpoint

Assessment of Feasibility

Time frame:2.5 years

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.