Obese Subjects With Polycystic Ovary Syndrome (PCOS)Phase 2NCT06595797
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
A Phase 2 study testing HRS9531 in people with Obese Subjects With Polycystic Ovary Syndrome (PCOS), run by Fujian Shengdi Pharmaceutical Co., Ltd..
Trial summary
Randomized, double-blind, placebo-controlled study of HRS9531 in PCOS subjects Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Obese Subjects With Polycystic Ovary Syndrome (PCOS)
- What is being tested?
- HRS9531
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
- 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
Show all 27Show fewer
- 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;
- 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;
- Present or suspected depression, anxiety disorder, bipolar disorder, suicidal tendencies, schizophrenia, or other more serious mental illness
- A known or suspected history of alcohol and/or drug abuse or drug use
- A history of acute or chronic hepatitis, or other serious liver disease other than alcoholic fatty liver disease;
- A history of unstable or rapidly progressing kidney disease or end-stage kidney disease
- Autoimmune disease is present and systemic glucocorticoid therapy or immunosuppressive therapy is planned for the study period;
- 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);
- Those who have donated blood or lost blood ≥400 mL in the previous 3 months, or received blood transfusion
- Surgery is planned during the trial period (except for minor surgery that the investigator believes will not affect the trial);
- Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process;
- 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;
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Randomized, double-blind, placebo-controlled study of HRS9531 in PCOS subjects
- Being tested
- HRS9531, HRS9531placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS9531Drug
HRS9531
HRS9531placeboDrug
HRS9531placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1 | Experimental | Not described Receives: Drug: HRS9531; Drug: HRS9531placebo |
| Treatment group 2 | Experimental | Not described Receives: Drug: HRS9531; Drug: HRS9531placebo |
| Treatment group 3 | Experimental | Not described Receives: Drug: HRS9531; Drug: HRS9531placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in body weight from baseline at 32 weeks of treatment
Measured: 0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week
Secondary outcomes (23)
Proportion of subjects with regular menstruation at 32 weeks of treatment
Measured: 0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week
Change in spontaneous menstrual frequency ratio from baseline at 32 weeks of treatment
Measured: 0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week
Proportion of subjects who ovulated regularly after 32 weeks of treatment
Measured: 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
Measured: 0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week
BMI changes relative to baseline after 32 weeks of administration;
Measured: 0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week
Changes in waist circumference (WC) from baseline after 32 weeks of administration
Measured: 0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week
Proportion of subjects with at least 3 menstrual cycles of 21-35 days after 12-32 weeks of treatment;
Measured: 0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week
Changes in total testosterone (TT)from baseline after 32 weeks of administration
Measured: 0week, 12week, 24week, 32week
Changes in sex hormone binding globulin (SHBG)from baseline after 32 weeks of administration
Measured: 0week, 12week, 24week, 32week
Changes in free testosterone index (FAI),from baseline after 32 weeks of administration
Measured: 0week, 12week, 24week, 32week
Changes in anti-Miller tube hormone (AMH),from baseline after 32 weeks of administration
Measured: 0week, 12week, 24week, 32week
Changes in follicle stimulating hormone (FSH),from baseline after 32 weeks of administration
Measured: 0week, 12week, 24week, 32week
Changes in luteinizing hormone (LH)from baseline after 32 weeks of administration
Measured: 0week, 12week, 24week, 32week
Changes in LH/FSH;from baseline after 32 weeks of administration
Measured: 0week, 12week, 24week, 32week
Changes in fasting plasma glucose (FPG)from baseline after 32 weeks of administration
Measured: 0week, 12week, 24week, 32week
Changes in fasting serum insulin (FINS),from baseline after 32 weeks of administration
Measured: 0week, 12week, 24week, 32week
Changes in insulin resistance index (HOMA-IR)from baseline after 32 weeks of administration
Measured: 0week, 12week, 24week, 32week
Changes in triglycerides from baseline after 32 weeks of administration
Measured: 0week, 12week, 24week, 32week
Changes in total cholesterol (TC),from baseline after 32 weeks of administration
Measured: 0week, 12week, 24week, 32week
Changes in, low density lipoprotein cholesterol (LDL-C)from baseline after 32 weeks of administration
Measured: 0week, 12week, 24week, 32week
Changes in high density lipoprotein cholesterol (HDL-C)from baseline after 32 weeks of administration
Measured: 0week, 12week, 24week, 32week
Changes in blood pressure from baseline
Measured: 0week, 4week,12week, 24week, 32week
Adverse events,
Measured: 0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startSep 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese Subjects With Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595797
- Sponsor's protocol ID
- HRS9531-207
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06595797
- Acronym / sponsor ID
- HRS9531-207
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-blind, placebo-controlled study of HRS9531 in PCOS subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1 | Experimental | Drug: HRS9531, Drug: HRS9531placebo |
| Treatment group 2 | Experimental | Drug: HRS9531, Drug: HRS9531placebo |
| Treatment group 3 | Experimental | Drug: HRS9531, Drug: HRS9531placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (27 listed)
- 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
- The presence of endocrine disorders or medical history that may significantly affect body weight
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS9531HRS9531 | Drug | Treatment group 1, Treatment group 2, Treatment group 3 |
| HRS9531placeboHRS9531placebo | Drug | Treatment group 1, Treatment group 2, Treatment group 3 |
Primary outcome
Percentage change in body weight from baseline at 32 weeks of treatment
Time frame: 0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week
23 secondary outcomes
Proportion of subjects with regular menstruation at 32 weeks of treatment
Time frame: 0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week
Change in spontaneous menstrual frequency ratio from baseline at 32 weeks of treatment
Time frame: 0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week
Proportion of subjects who ovulated regularly after 32 weeks of treatment
Time frame: 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
Time frame: 0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week
BMI changes relative to baseline after 32 weeks of administration;
Time frame: 0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week
Changes in waist circumference (WC) from baseline after 32 weeks of administration
Time frame: 0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week
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
Changes in total testosterone (TT)from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in sex hormone binding globulin (SHBG)from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in free testosterone index (FAI),from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in anti-Miller tube hormone (AMH),from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in follicle stimulating hormone (FSH),from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in luteinizing hormone (LH)from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in LH/FSH;from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in fasting plasma glucose (FPG)from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in fasting serum insulin (FINS),from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in insulin resistance index (HOMA-IR)from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in triglycerides from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in total cholesterol (TC),from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in, low density lipoprotein cholesterol (LDL-C)from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in high density lipoprotein cholesterol (HDL-C)from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in blood pressure from baseline
Time frame: 0week, 4week,12week, 24week, 32week
Adverse events,
Time frame: 0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS9531 in people with Obese Subjects With Polycystic Ovary Syndrome (PCOS), run by Fujian Shengdi Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuang Li (0518-82342973, Shuang.li.sl100@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in body weight from baseline at 32 weeks of treatment (time frame: 0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.