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Trial Title:
Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
NCT ID:
NCT06073184
Condition:
Endometrial Cancer
Atypical Hyperplasia
Conditions: Official terms:
Endometrial Neoplasms
Weight Loss
Hyperplasia
Tirzepatide
Progestins
Conditions: Keywords:
Tirzepatide
pIUD
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is a prospective, randomized, open label, multicentre, phase II, non-comparative
study to determine the efficacy and safety of a GLP-1R/GIPR coagonist in combination with
standard pIUD in patients with EC/AH who wish to preserve their fertility.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Mounjaro
Description:
Tirzepatide injection, starting dose is 2.5mg injected subcutaneously once weekly. After
4 weeks, dose should be increased to 5mg once weekly. The dose then can be increased in
2.5mg increments after no less than 4 weeks on current dose to maximum dose of 15mg once
weekly.
Arm group label:
Intervention Arm
Other name:
Tirzepatide
Intervention type:
Drug
Intervention name:
Mirena
Description:
Levonorgestrel-releasing Intrauterine System (52mg) to deliver up to 20 mcg
levonorgestrel per day
Arm group label:
Control Arm
Arm group label:
Intervention Arm
Other name:
Progestin-releasing intra-uterine device (pIUD)
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 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.
Detailed description:
The research aims to answer the question: "Does the addition of Glucagon-like Peptide-1
(GLP-1) agonist 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, historically controlled, open-label phase 2 study to
assess the safety and efficacy of the combination of semaglutide (GLP-1) and pIUD.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. People aged ≥ 18 and ≤ 41 years of age
2. BMI ≥ 27
3. Diagnosis of grade 1 or 2 endometrioid EC or AH made by either endometrial biopsy or
dilation and curettage
4. Clinical FIGO 2009 stage 1A disease - no evidence of metastatic disease beyond the
uterus and no evidence of myometrial invasion by imaging performed (MRI, CT)
5. ECOG status <2
6. Desire for fertility preservation
7. Have signed an approved informed consent form
Exclusion Criteria:
1. Evidence of myometrial invasion or extra-uterine disease on imaging
2. High grade or p53 mutated (p53mut) EC
3. Estrogen receptor (ER) EC
4. Mismatch repair deficient (MMRd) EC
5. History of other malignancies, except if:
a. Curatively treated with no evidence of disease for >5 years
6. Previous surgical treatment of obesity
7. Current use of weight loss medication (no use in last 6 months)
8. Medical co-morbidity with end-organ dysfunction
9. Unable to understand and participate in the informed consent process
10. Currently pregnant or breastfeeding (negative serum bhCG at screening)
11. Contraindications to progestin intra-uterine device (pIUD)
12. History of chronic pancreatitis or acute pancreatitis within 180 days prior to
screening
13. Contraindications to tirzepatide
1. Personal or first-degree history of multiple endocrine neoplasia type 2 or
medullary thyroid carcinoma
2. Anaphylactic reaction
Gender:
Female
Minimum age:
18 Years
Maximum age:
41 Years
Healthy volunteers:
No
Start date:
September 2024
Completion date:
September 2031
Lead sponsor:
Agency:
University Health Network, Toronto
Agency class:
Other
Source:
University Health Network, Toronto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06073184
