← Trials/Trial dossier/NCT06595797

Not yet recruitingPhase 2

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

Asset

HRS9531

GLP-1 / GIP dual

Listed sites

0

Recruiting sites

Enrollment

144

estimated

Study population

Obesity / overweight, PCOS

Key I/E criteria

BMI ≥28Female

Primary endpoint

Body weight, % change

Identifiers

Registered as

NCT IDNCT06595797
Org study IDHRS9531-207

Timeline

Milestones

Study first posted2024-09-19actual
Last update posted2024-09-19actual
Study start2024-09estimated (month precision)
Primary completion2025-12estimated (month precision)
Study completion2025-12estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightPCOS

Eligibility

Who can enroll

Minimum age18 Years
Maximum age40 Years
SexFemale
Healthy volunteersNot accepted

Inclusion criteria

1. 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

2. Women aged 18-40 (including the threshold) on the date of signing the informed consent;

3. Patients who meet the diagnostic criteria for polycystic ovary syndrome;

4. Body mass index (BMI) ≥28 kg/m2;

5. Have controlled diet and exercise for at least 3 months, and the weight change is less than 5 kg

6. 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

Exclusion criteria

1. Endometrial biopsy is necessary as assessed by the investigators, and the pathology of the endometrial biopsy indicates significant abnormalities

2. 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

3. Poor blood pressure control (with or without antihypertensive therapy) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening

4. PHQ-9 score ≥15 points

5. The presence of endocrine disorders or medical history that may significantly affect body weight

6. Presence of other medical conditions or history that may cause hyperandrostenia or irregular menstruation

7. 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)

8. Abnormal uterine bleeding for reasons other than PCOS or unexplained abnormal uterine bleeding occurred within 6 months

9. Endometrium-related surgery within 1 year indicated significant pathological abnormalities of endometrial tissue, and safety risks were assessed by researchers

10. History of pregnancy, miscarriage, childbirth or breastfeeding within 6 months

11. 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);

12. 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);

13. History or family history of medullary thyroid carcinoma (MTC) or multiple endocrine adenomatosis type 2 (MEN2);

14. Severe infection, severe trauma, or major or major surgery in the previous 6 months

15. 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;

16. Any organ-system malignancy within the previous 5 years, regardless of evidence of local recurrence or metastasis, except cured local basal cell carcinoma of the skin, cervical carcinoma in situ, and prostate carcinoma in situ;

17. Present or suspected depression, anxiety disorder, bipolar disorder, suicidal tendencies, schizophrenia, or other more serious mental illness

18. A known or suspected history of alcohol and/or drug abuse or drug use

19. A history of acute or chronic hepatitis, or other serious liver disease other than alcoholic fatty liver disease;

20. A history of unstable or rapidly progressing kidney disease or end-stage kidney disease

21. Autoimmune disease is present and systemic glucocorticoid therapy or immunosuppressive therapy is planned for the study period;

22. Participated in a clinical trial of any drug or medical device within the previous 3 months, defined as signing informed consent and using the investigational drug (including placebo) or the investigational medical device; Or is still in the trial drug within 5 half-lives (whichever is older);

23. Those who have donated blood or lost blood ≥400 mL in the previous 3 months, or received blood transfusion

24. Surgery is planned during the trial period (except for minor surgery that the investigator believes will not affect the trial);

25. Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process;

26. Researchers and relevant staff of the research Centre or others directly involved in the implementation of the programme, as well as members of their immediate family (e.g. spouse, legal partner, parents, children or siblings); Hengrui company staff;

27. There are circumstances (medical, psychological, social or geographical factors, etc.) that, in the investigator's judgment, affect the subject's safety or any other conditions that interfere with the evaluation of the test results.

Endpoints (24)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
10
Cardiometabolic biomarkers
5
Weight & body composition
4
Glycemic / diabetes
3
Safety / tolerability / PK
1
Other (unclassified)
1

Weight & body composition

4 endpoints
Primary/protocol endpoint

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

Time frame:0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

BMI changes relative to baseline after 32 weeks of administration;

Time frame:0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Changes in waist circumference (WC) from baseline after 32 weeks of administration

Time frame:0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Changes in fasting plasma glucose (FPG)from baseline after 32 weeks of administration

Time frame:0week, 12week, 24week, 32week

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Changes in fasting serum insulin (FINS),from baseline after 32 weeks of administration

Time frame:0week, 12week, 24week, 32week

change from baseline, improvement

Secondary/protocol endpoint

Changes in insulin resistance index (HOMA-IR)from baseline after 32 weeks of administration

Time frame:0week, 12week, 24week, 32week

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

5 endpoints
Secondary/protocol endpoint

Changes in triglycerides from baseline after 32 weeks of administration

Time frame:0week, 12week, 24week, 32week

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Changes in total cholesterol (TC),from baseline after 32 weeks of administration

Time frame:0week, 12week, 24week, 32week

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Changes in, low density lipoprotein cholesterol (LDL-C)from baseline after 32 weeks of administration

Time frame:0week, 12week, 24week, 32week

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Changes in high density lipoprotein cholesterol (HDL-C)from baseline after 32 weeks of administration

Time frame:0week, 12week, 24week, 32week

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Changes in blood pressure from baseline

Time frame:0week, 4week,12week, 24week, 32week

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Adverse events,

Time frame:0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week

Treatment-emergent AEs (any)

descriptive, event

Other clinical outcomes

10 endpoints
Secondary/protocol endpoint

Proportion of subjects with regular menstruation at 32 weeks of treatment

Time frame:0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week

Menstrual cyclicity

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week

Menstrual cyclicity

change from baseline, improvement

Secondary/protocol endpoint

Proportion of subjects who ovulated regularly after 32 weeks of treatment

Time frame:0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week

Ovulation rate

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of subjects with at least 3 menstrual cycles of 21-35 days after 12-32 weeks of treatment;

Time frame:0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week

Menstrual cyclicity

threshold achievement, improvement

Secondary/protocol endpoint

Changes in total testosterone (TT)from baseline after 32 weeks of administration

Time frame:0week, 12week, 24week, 32week

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Changes in free testosterone index (FAI),from baseline after 32 weeks of administration

Time frame:0week, 12week, 24week, 32week

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Changes in anti-Miller tube hormone (AMH),from baseline after 32 weeks of administration

Time frame:0week, 12week, 24week, 32week

change from baseline, improvement

Secondary/protocol endpoint

Changes in follicle stimulating hormone (FSH),from baseline after 32 weeks of administration

Time frame:0week, 12week, 24week, 32week

change from baseline, improvement

Secondary/protocol endpoint

Changes in luteinizing hormone (LH)from baseline after 32 weeks of administration

Time frame:0week, 12week, 24week, 32week

change from baseline, improvement

Secondary/protocol endpoint

Changes in LH/FSH;from baseline after 32 weeks of administration

Time frame:0week, 12week, 24week, 32week

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Changes in sex hormone binding globulin (SHBG)from baseline after 32 weeks of administration

Time frame:0week, 12week, 24week, 32week

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.