About this trial
Randomized, double-blind, placebo-controlled study of HRS9531 in PCOS subjects
Eligibility criteria
Qualifiers
With my consent and signed informed consent, I am willing and able to complete this study in accordance with the requirements of the experimental protocol
Women aged 18-40 (including the threshold) on the date of signing the informed consent;
Patients who meet the diagnostic criteria for polycystic ovary syndrome;
Body mass index (BMI) ≥28 kg/m2;
Disqualifiers
Endometrial biopsy is necessary as assessed by the investigators, and the pathology of the endometrial biopsy indicates significant abnormalities
12-lead electrocardiogram (ECG) results showing clinically significant abnormalities that may affect the safety of the subject, including but not limited to myocardial infarction, severe arrhythmias (e.g., supraventricular tachycardia, atrial fibrillation, atrial flutter, degree II or III atrioventricular block, etc.), and QTcF > 470 ms
Poor blood pressure control (with or without antihypertensive therapy) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening
PHQ-9 score ≥15 points
Trial design
Treatments tested in this trial
- HRS9531
- HRS9531placebo