The goal of this clinical trial is to learn the efficacy of Mazdutide in treating obese female adults diagnosed with polycystic ovary syndrome (PCOS). The main question it aims to answer is: Does Mazdutide lower the free androgen index (FAI) in obese female adults with PCOS? Participants will take Mazdutide once every week for 24 weeks and visit the clinic once every 4 weeks for checkups and tests.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
In the initial 4 weeks, the subjects are given Mazdutide 2mg once weekly. If well tolerated, the dosage is increased to 4mg once weekly for another 4 weeks. If still well tolerated, the dosage is further increased to 6mg once weekly and maintained for the ensuing 16 weeks.
Zhongshan Hospital Fudan University
Shanghai, China
Free Androgen Index (FAI)
FAI=total testosterone (nmol/L)/ sex hormone binding globulin (nmol/L) X 100
Time frame: 24 weeks
Times of regular menses
Record of vaginal bleeding within 24 weeks after using Mazdutide
Time frame: 24 weeks
Number of immature follicles
Total number of follicles measuring 2-9 mm in diameter on ultrasound
Time frame: 24 weeks
Bilateral ovary volume
Total ovary volume is calculated based on length, width and height of bilateral ovaries measured by ultrasound
Time frame: 24 weeks
Serum anti-Mullerian hormone (AMH)
Measurement of serum AMH
Time frame: 24 weeks
HOMA insulin resistance index (HOMA-IR)
HOMA-IR=fasting plasma glucose (mmol/L)×fasting insulin (μU/mlINS)/22.5
Time frame: 24 weeks
HbA1c
Measurement of HbA1c
Time frame: 24 weeks
body mass index (BMI)
BMI = weight / height² (weight in kilograms and height in meters)
Time frame: 24 weeks
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