Endometrial CancerPhase 2WE-FiERCENCT06073184
Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Low-grade Cancer of the Endometrium
A Phase 2 study testing Wegovy and Mirena in people with Endometrial Cancer and Atypical Hyperplasia, run by GynOncTrials at 1 site in Canada.
Trial summary
The incidence of endometrial cancer is increasing at an alarming rate. This trend parallels the rising rate of obesity, the most significant risk factor for endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia who want to maintain their fertility are treated with progestin… Read more about this study
- Who is it for?
- Ages 18 to 41 years, women only
- Conditions the study is for
- Endometrial Cancer, Atypical Hyperplasia, Fertility Perservation
- What is being tested?
- Wegovy and Mirena
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteCanada
- Study dates
- 17 Sep 2026to Feb 2032
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 41 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- BMI ≥ 27
- Diagnosis of grade 1 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
Who cannot join
- 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
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- Current use of weight loss medication (no use in last 2 months)
- Medical comorbidity with end-organ dysfunction
- History of suicide attempts or current suicidal thoughts or behaviours
- Currently taking insulin or insulin secretagogue (e.g., sulfonylurea)
- Diabetic retinopathy
- Gastroparesis or problems with food digestion
- History of tachycardia (e.g., sinus tachycardia, supraventricular tachycardia, atrial fibrillation, atrial flutter, or ventricular tachycardia)
- Contraindications to pIUD or semaglutide.
- Hypersensitive to WEGOVY or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container
- Personal or family history of medullary thyroid carcinoma (MTC)
- Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Pregnant or breast-feeding
- Current or recurrent pelvic inflammatory disease
- Lower genital tract infection
- Postpartum endometritis
- Uterine anomalies including fibroids if they distort the uterine cavity
- Cervical malignancy
- Known or suspected progestin-dependent neoplasia, including breast cancer
- Cervicitis
- Untreated cervical dysplasia
- Active liver disease or dysfunction
- Actual benign or malignant liver tumors
- Sceptic abortion within the previous three months
- Hypersensitivity to levonorgestrel or any of the other ingredients in the formulation or components of MIRENA.
- Bacterial endocarditis
- Established immunodeficiency
- Acute malignancies affecting blood or leukemias
- Recent trophoblastic disease while hCG levels are elevated
- Previously inserted intrauterine device (IUD) that has not been removed
- Conditions associated with increased susceptibility to pelvic infections
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre, University Health Network
Toronto, Ontario
About this study
Official title: Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium (WE-FiERCE)
The incidence of endometrial cancer is increasing at an alarming rate. This trend parallels the rising rate of obesity, the most significant risk factor for endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia who want to maintain their fertility are treated with progestin therapy, such as progestin intra-uterine device (pIUD), which is associated with a mediocre response rate and high recurrence rate, and does not address the underlying cause, obesity. Therefore, the investigators want to assess whether the addition of a weight-loss drug to pIUD will improve their oncologic, reproductive and metabolic outcomes.
Read the detailed description
The research aims to answer the question: "Does the addition of a Glucagon-like Peptide-1 (GLP-1) to standard progestin treatment lead to a higher complete response rate compared to historical response rates using progestin alone in young patients with endometrial cancer/atypical hyperplasia who wish to preserve their fertility?".
This is a multicentre single arm open-label phase II clinical trial to assess the complete pathologic response as determined by endometrial sampling after 48 weeks of semaglutide (GLP-1) and progestin therapy in patients with BMI ≥ 27 who have endometrial cancer/atypical hyperplasia and desire fertility preservation.
- Being tested
- Wegovy, Mirena
- Keywords
- pIUD, semaglutide, WEGOVY, atypical hyperplasia, endometrial cancer, fertility preservation
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WegovyDrug
Also called Semaglutide
Weekly subcutaneous injection of 0.25 mg semaglutide at baseline with dose escalation every 4 weeks to reach 2.4 mg or the maximum tolerated dose, by Week 16
MirenaDrug
Also called Progestin-releasing intra-uterine device (pIUD)
Levonorgestrel-releasing Intrauterine System (52mg) to deliver up to 20 mcg levonorgestrel per day
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide and Progestin Intrauterine Device | Experimental | All patients will receive a progestin intrauterine device and semaglutide subcutaneous injections Receives: Drug: Wegovy; Drug: Mirena |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Complete Pathologic Response
Proportion of patients (%) who achieve pathological complete response at 48 weeks after initiation of pIUD and semaglutide.
Measured: 48 weeks
Secondary outcomes (6)
Assessment of Safety and Tolerability
Adverse events during treatment period
Measured: 48 weeks
Assessment of Feasibility
Rate of accrual; patient compliance; retention
Measured: 1.5 years
Assessment of Secondary Oncologic Outcomes
Time to achieve complete response; duration of response; recurrence rate; time to recurrence; progression/persistence rate
Measured: 6 years
Assessment of Reproductive Outcomes
Rate of pregnancy; live birth; miscarriage; pregnancy complications
Measured: 6 years
Assessment of Patient Reported Outcomes
Quality of life; psychological functioning and fertility concerns after cancer diagnosis
Measured: 48 weeks
Assessment of Metabolic Outcomes
Weight; BMI; waist/hip circumference; serum biomarkers of obesity and insulin resistance
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start17 Sep 2026
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GynOncTrials
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, GynOncTrials, University Health Network, Toronto
- Investigators
- Rachel Soyoun Kim, MD, Principal investigator, University Health Network, TorontoSarah E Ferguson, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073184
- Sponsor's protocol ID
- WE-FiERCE-2
- Acronym
- WE-FiERCE
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No