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

NCT06595797 | Not Yet Recruiting Phase 2

• 1 other identifier: HRS9531-207
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

Randomized, double-blind, placebo-controlled study of HRS9531 in PCOS subjects

Conditions

Obese Subjects With Polycystic Ovary Syndrome (PCOS)

Outcome Measures

Primary Outcomes (1)

• Percentage change in body weight from baseline at 32 weeks of treatment

  0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week

Secondary Outcomes (23)

• Proportion of subjects with regular menstruation at 32 weeks of treatment

  0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week

• Change in spontaneous menstrual frequency ratio from baseline at 32 weeks of treatment

  0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week

• Proportion of subjects who ovulated regularly after 32 weeks of treatment

  0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week

• Proportion of subjects with weight loss of ≥5%, ≥10%, ≥15%, ≥20% from baseline at 32 weeks of treatment

  0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week

• BMI changes relative to baseline after 32 weeks of administration;

  0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week

Study Arms (3)

Treatment group 1

EXPERIMENTAL

Drug: HRS9531; Drug: HRS9531placebo

Treatment group 2

EXPERIMENTAL

Drug: HRS9531; Drug: HRS9531placebo

Treatment group 3

EXPERIMENTAL

Drug: HRS9531; Drug: HRS9531placebo

Interventions

HRS9531 DRUG

HRS9531

Treatment group 1; Treatment group 2; Treatment group 3

HRS9531placebo DRUG

HRS9531placebo

Treatment group 1; Treatment group 2; Treatment group 3

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Have controlled diet and exercise for at least 3 months, and the weight change is less than 5 kg
• Within 2 months from the signing of the informed consent to the last drug use, there is no family planning and consent to take trial-approved contraceptive measures, and there is no egg donation plan

You may not qualify if:

• Endometrial biopsy is necessary as assessed by the investigators, and the pathology of the endometrial biopsy indicates significant abnormalities
• 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
• The presence of endocrine disorders or medical history that may significantly affect body weight
• Presence of other medical conditions or history that may cause hyperandrostenia or irregular menstruation
• Presence of a history of gynecological conditions that may affect the evaluation of menstruation (including, but not limited to, history of hysterectomy, vaginal atresia, uterine adhesions)
• Abnormal uterine bleeding for reasons other than PCOS or unexplained abnormal uterine bleeding occurred within 6 months
• Endometrium-related surgery within 1 year indicated significant pathological abnormalities of endometrial tissue, and safety risks were assessed by researchers
• History of pregnancy, miscarriage, childbirth or breastfeeding within 6 months
• Have any disease or history that affects gastric empty. such as gastric bypass surgery, pyloric stenosis, etc., long-term use of drugs that directly affect gastrointestinal motility, serious gastrointestinal disease (such as active peptic ulcer, inflammatory bowel disease, etc.), or have undergone gastrointestinal surgery (except surgery that has no significant effect on gastrointestinal motility), Such as gastrointestinal polypectomy, appendectomy and hemorrhoid surgery);
• A history or disease of acute or chronic pancreatitis or pancreatic injury; Patients with a history of acute cholecystitis or symptomatic/treatable gallbladder disease (except those who had previously undergone cholecystectomy and were deemed eligible by the investigator to be enrolled);
• History or family history of medullary thyroid carcinoma (MTC) or multiple endocrine adenomatosis type 2 (MEN2);
• Severe infection, severe trauma, or major or major surgery in the previous 6 months
• A history of severe cardiovascular and cerebrovascular disease, including decompensated heart failure (New York Heart Association ratings III and IV), unstable angina pectoris, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, or coronary bypass grafting or percutaneous coronary intervention within the previous 6 months;

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Central Study Contacts

Shuang Li

CONTACT

0518-82342973; Shuang.li.sl100@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-08