Polycystic Ovary Syndrom
Conditions
Interventions
HRS9531 Group:HRS9531 injection
Placebo Group:Placebo
Sponsors
The First Affiliated Hospital of Henan University of Science and Technology
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Women diagnosed with polycystic ovary syndrome according to the 2003 Rotterdam diagnostic criteria; Patients with thin menstruation or amenorrhea 3 months before enrollment; 2. No oral contraceptives, metformin, glucocorticoid therapy in the past 3 months; 3. Body mass index (BMI) at screening was 26.0~40.0 kg/m2 (including the cut-off value); 4. Self-reported diet and exercise control for 3 months or more before screening, and the weight change in the last 3 months does not exceed 5 kg; 5. The age of signing the informed consent is 18-40 years old (including both ends); 6. With the patient's consent and signed informed consent, willing and able to complete the study in accordance with the requirements of the experimental protocol.
Exclusion criteria
Exclusion criteria: 1. Laboratory examination meets the following conditions:Fasting blood glucose =7.0 mmol/L, or HbA1c =6.5%; Hemoglobin 5.64 mmol/L ; calcitonin =50 ng/L; Blood amylase or lipase =3×ULN, or the investigator judged it to be clinically significant; Thyroid stimulating hormone (TSH) 6.0 mIU/L; Abnormalities in other laboratory tests may affect the assessment of efficacy or safety by the researcher; 2. 12 lead electrocardiogram (ECG) examination shows abnormalities and the researcher determines that it may affect the safety of the subjects, including but not limited to myocardial infarction, significant arrhythmia, QTcF>450 ms, etc; 3. Poor blood pressure control: systolic blood pressure = 160 mmHg, or diastolic blood pressure = 100 mmHg (if using antihypertensive drugs, stable treatment is required for at least 1 month); 4. Health Questionnaire 9 (PHQ-9) score =15 points; 5. There are endocrine disorders or medical histories that may significantly affect weight (such as Cushing's syndrome, hypothyroidism or hyperthyroidism, except for hypothyroidism where the dose of thyroid hormone replacement has stabilized for at least 3 months); 6. Endocrine diseases that may cause menstrual abnormalities; 7. Have a history of pregnancy, miscarriage, or childbirth within the past 6 weeks, or have a history of breastfeeding within 6 months; 8. Difficulty in evaluating menstruation or ovulation; 9. Cervical polyps, cervical submucosal fibroids, and cervical and vaginal lesions that may cause abnormal vaginal bleeding as determined by researchers; 10. History of diabetes (except diabetes in pregnancy); 11. Individuals who have had any previous experience affecting gastric emptying or have undergone gastrointestinal surgery (excluding surgeries that have no significant impact on gastrointestinal motility, such as polypectomy, appendectomy, and hemorrhoid surgery); 12. Previous or known history of acute or chronic pancreatitis; Patients with a history of acute cholecystitis or chronic cholecystitis or gallstones that require treatment (excluding subjects who have previously undergone cholecystectomy and have been determined by the researcher to be eligible for enrollment); 13. Individuals with a history of chronic malabsorption syndrome or cholestasis; 14. Previous or known history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) or family history; 15. Screening for severe infection, severe trauma, or undergoing large or medium-sized surgery within the previous month; 16. Screening for a history of severe cardiovascular and cerebrovascular diseases within the first 6 months, including decompensated heart failure (NYHA grades III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, or coronary artery bypass grafting or percutaneous coronary intervention; 17.Within 5 years, any malignant tumor of the organ system has occurred, regardless of whether there is evidence of local recurrence or metastasis, except for locally cured basal cell carcinoma of the skin and cervical carcinoma in situ; 18. Individuals with or suspected of depression, bipolar disorder, suicidal tendencies, schizophrenia, or other more serious mental illnesses; 19. Screening for a histor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Menstrual frequency;Weight; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects who recovered regular menstruation;Laboratory test index;Ultrasonic examination index;Liver fat content; | — |
Countries
China
Contacts
Public ContactHongwei Jiang
The First Affiliated Hospital of Henan University of Science and Technology
Outcome results
None listed