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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mazdutide Treatment Arm | Experimental | Subcutaneous injection of Mazdutide once weekly for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mazdutide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Free Androgen Index (FAI) | FAI=total testosterone (nmol/L)/ sex hormone binding globulin (nmol/L) X 100 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Times of regular menses | Record of vaginal bleeding within 24 weeks after using Mazdutide | 24 weeks |
| Number of immature follicles | Total number of follicles measuring 2-9 mm in diameter on ultrasound |
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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 :
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LIANGSHAN MU, MD, PhD | Contact | 02164041990 | 695904 | mu.liangshan@zs-hospital.sh.cn |
| JINGJING JIANG, MD, PhD | Contact | 02164041990 | 692023 | jiang.jingjing@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| XI DONG, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Fudan University | Recruiting | Shanghai | 200032 | China |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| C000719829 | mazdutide |
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| ID | Term |
|---|---|
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
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|
|
| 24 weeks |
| Bilateral ovary volume | Total ovary volume is calculated based on length, width and height of bilateral ovaries measured by ultrasound | 24 weeks |
| Serum anti-Mullerian hormone (AMH) | Measurement of serum AMH | 24 weeks |
| HOMA insulin resistance index (HOMA-IR) | HOMA-IR=fasting plasma glucose (mmol/L)×fasting insulin (μU/mlINS)/22.5 | 24 weeks |
| HbA1c | Measurement of HbA1c | 24 weeks |
| body mass index (BMI) | BMI = weight / height² (weight in kilograms and height in meters) | 24 weeks |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |