A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of HRS9531 Injection in Obese Subjects With Polycystic Ovary Syndrome

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

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

Treatment groups

144 Participants
are divided into 3 treatment groups

Locations

This trial has no locations