Randomized, double-blind, placebo-controlled study of HRS9531 in PCOS subjects
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;
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
Parallel
HRS9531
DrugHRS9531
HRS9531placebo
DrugHRS9531placebo
Percentage change in body weight from baseline at 32 weeks of treatment
Proportion of subjects with regular menstruation at 32 weeks of treatment
Change in spontaneous menstrual frequency ratio from baseline at 32 weeks of treatment
Proportion of subjects who ovulated regularly after 32 weeks of treatment
Proportion of subjects with weight loss of ≥5%, ≥10%, ≥15%, ≥20% from baseline at 32 weeks of treatment
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This trial is not recruiting at the moment. You can still explore other options:
