Polycystic Ovary Syndrome
Conditions
Brief summary
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.
Interventions
DRUGMazdutide
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.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* BMI≥28kg/M2 * No plan for pregnancy in the coming 8 months after enrollment * Patients should meet at least two of the three criteria according to the 2023 international evidence-based guideline for PCOS : 1. Irregular cycles and ovulatory dysfunction: \< 21 or \> 35 days or \< 8 cycles per year; \> 90 days for any one cycle 2. Polycystic ovaries: ≥20 follicles in at least one of two ovaries (diameter\<10mm), confirmed by ultrasound 3. Biochemical hyperandrogenism: total testosterone\>1.67 nmol/L or clinical hyperandrogenism: modified Ferriman Gallwey score (mFG)\>4
Exclusion criteria
* Previous history of acute or chronic pancreatitis or pancreatic injury * Previous history or family history of medullary thyroid cancer, multiple endocrine neoplasia type 2a or 2b * Severe hypertriglyceridemia (TG\>5mmol/L) * Type 1 or type 2 diabetes mellitus * Other endocrine diseases that can cause secondary PCOS, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc * Pregnancy or breast-feeding * Patients with other serious diseases affecting heart, liver, kidney, or other major organs * Patients with any type of cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Free Androgen Index (FAI) | 24 weeks | FAI=total testosterone (nmol/L)/ sex hormone binding globulin (nmol/L) X 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 24 weeks | Measurement of HbA1c |
| body mass index (BMI) | 24 weeks | BMI = weight / height² (weight in kilograms and height in meters) |
| Times of regular menses | 24 weeks | Record of vaginal bleeding within 24 weeks after using Mazdutide |
| HOMA insulin resistance index (HOMA-IR) | 24 weeks | HOMA-IR=fasting plasma glucose (mmol/L)×fasting insulin (μU/mlINS)/22.5 |
| Bilateral ovary volume | 24 weeks | Total ovary volume is calculated based on length, width and height of bilateral ovaries measured by ultrasound |
| Serum anti-Mullerian hormone (AMH) | 24 weeks | Measurement of serum AMH |
| Number of immature follicles | 24 weeks | Total number of follicles measuring 2-9 mm in diameter on ultrasound |
Countries
China
Contacts
Primary ContactLIANGSHAN MU, MD, PhD
Backup ContactJINGJING JIANG, MD, PhD
Outcome results
None listed