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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Not Receiving Positive Airway Pressure (PAP) Therapy

A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity (NCT06974851) is a Phase 3 interventional studying Bstructive Sleep Apnea (OSA) and Obesity, sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects with Obstructive Sleep Apnea (OSA) and Obesity

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Bstructive Sleep Apnea (OSA) and Obesity, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 140 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Bstructive Sleep Apnea (OSA) and Obesity subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. The participant has provided willing to sign a consent form and is willing and able to comply with the study protocol requirements to complete the study. 2. Age between 18 and 75 years, male or female, at the time of signing the willing to sign a consent form form. 3. BMI ≥ 28.0 kg/m² at screening. 4. Has been on a controlled diet and exercise regimen for 3 months or more, with a weight change of ≤ 5.0 kg in the past 3 months. 5. Polysomnography (PSG) results at screening confirm OSA. 6. Female participants of childbearing potential and male participants with partners of childbearing potential agree to use highly effective contraception from the time of signing the willing to sign a consent form form until 2 months after the last dose, with no plans for pregnancy or donation of eggs/sperm during this period. Female participants of childbearing potential must have a negative pregnancy test within 3 days prior to randomization and must not be breastfeeding. Who Should NOT Join This Trial: 1. Laboratory Test Abnormalities: 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), or total bilirubin (TBIL) ≥ 2.0 × ULN. 2. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m² (calculated using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula based on serum creatinine). 3. Thyroid-stimulating hormone (TSH) \< 0.4 or \> 6.0 mIU/L. 4. Other laboratory abnormalities judged by the investigator to potentially affect efficacy or safety assessments. 2. Clinically Significant ECG Abnormalities: ECG findings deemed clinically significant by the investigator, including but not limited to myocardial infarction, severe arrhythmias (e.g., supraventricular tachycardia, atrial fibrillation, atrial flutter, second- or third-degree atrioventricular block, etc.), which may affect participant safety. 3. Poorly Controlled Blood Pressure: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. The participant has provided informed consent and is willing and able to comply with the study protocol requirements to complete the study. 2. Age between 18 and 75 years, male or female, at the time of signing the informed consent form. 3. BMI ≥ 28.0 kg/m² at screening. 4. Has been on a controlled diet and exercise regimen for 3 months or more, with a weight change of ≤ 5.0 kg in the past 3 months. 5. Polysomnography (PSG) results at screening confirm OSA. 6. Female participants of childbearing potential and male participants with partners of childbearing potential agree to use highly effective contraception from the time of signing the informed consent form until 2 months after the last dose, with no plans for pregnancy or donation of eggs/sperm during this period. Female participants of childbearing potential must have a negative pregnancy test within 3 days prior to randomization and must not be breastfeeding. Exclusion Criteria: 1. Laboratory Test Abnormalities: 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), or total bilirubin (TBIL) ≥ 2.0 × ULN. 2. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m² (calculated using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula based on serum creatinine). 3. Thyroid-stimulating hormone (TSH) \< 0.4 or \> 6.0 mIU/L. 4. Other laboratory abnormalities judged by the investigator to potentially affect efficacy or safety assessments. 2. Clinically Significant ECG Abnormalities: ECG findings deemed clinically significant by the investigator, including but not limited to myocardial infarction, severe arrhythmias (e.g., supraventricular tachycardia, atrial fibrillation, atrial flutter, second- or third-degree atrioventricular block, etc.), which may affect participant safety. 3. Poorly Controlled Blood Pressure: Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg. 4. PHQ-9 Score ≥ 15: Patient Health Questionnaire-9 (PHQ-9) score ≥ 15. 5. Medical History or Conditions Prior to Screening or Randomization: 1. Endocrine disorders or monogenic mutations causing obesity or hereditary obesity syndromes that may significantly affect weight. 2. Diabetes mellitus. 3. Diagnosis of central or mixed sleep apnea or Cheyne-Stokes respiration. 4. Respiratory or neuromuscular diseases judged by the investigator to potentially interfere with trial results. 5. Clinical abnormalities or diseases related to insomnia or excessive sleepiness (excluding OSA). 6. History of conditions affecting gastric emptying, long-term use of medications directly affecting gastrointestinal motility, severe gastrointestinal diseases, or prior gastrointestinal surgery. 7. History of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic/treatment-requiring gallbladder disease. 8. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2). 9. Severe infections, significant trauma, or major/moderate surgery within 1 month prior to screening. 10. Severe cardiovascular or cerebrovascular events within 6 months prior to screening, including decompensated heart failure (NYHA Class III or IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmias, or cardiac surgeries such as coronary artery bypass grafting or percutaneous coronary intervention. 11. Malignancy in any organ system within the past 5 years, regardless of evidence of local recurrence or metastasis (except cured local basal cell carcinoma, cervical carcinoma in situ, and prostate carcinoma in situ). 12. Presence or suspicion of depression, bipolar disorder, suicidal tendencies, schizophrenia, or other severe psychiatric disorders. 13. Known or suspected history of alcohol and/or drug abuse or drug addiction. 14. Acute or chronic hepatitis or other severe liver diseases (excluding non-alcoholic fatty liver disease). 15. Severe hematologic diseases (e.g., aplastic anemia, myelodysplastic syndrome, hemolytic anemia, sickle cell disease) or any condition causing hemolysis or red blood cell instability (e.g., malaria). 16. Autoimmune diseases requiring systemic corticosteroid or immunosuppressive therapy during the study period. 6. Medications or Treatments Prior to Screening: 1. Use of medications or treatments likely to cause significant weight gain or loss within 3 months prior to screening. 2. Medications or treatments judged by the investigator to potentially affect sleepiness assessments. 3. Prior or planned bariatric surgery (except liposuction performed more than 1 year ago). 4. Prior or planned endoscopic or device-based weight loss treatments, or device removal within the past 6 months (e.g., mucosal ablation, gastric artery embolization, intragastric balloons, duodenal-jejunal bypass sleeves). 5. Use of positive airway pressure (PAP) or other OSA treatments judged by the investigator to potentially interfere with study results (e.g., oral appliances, neurostimulation therapy), unless the participant is willing to discontinue such treatments 4 weeks prior to screening and during the study. 6. Requirement for supplemental oxygen. 7. Other Exclusion Criteria: 1. Participation in any drug or medical device clinical trial within 3 months prior to screening, defined as signing informed consent and using the investigational product (including placebo) or medical device, or still within 5 half-lives of the investigational drug (whichever is longer). 2. History of blood donation or blood loss ≥ 400 mL within 3 months prior to screening, or receipt of a blood transfusion within 3 months. 3. Planned surgery during the trial (except minor surgeries deemed by the investigator to not affect the trial). 4. Participants with mental incapacity or language barriers unable to fully understand or participate in the trial. 5. Any condition judged by the investigator to affect participant safety or interfere with the evaluation of trial results (medical, psychological, social, or geographical factors, etc.). 6. Investigators, research site staff, or other individuals directly involved in the execution of the protocol, and their immediate family members (e.g., spouse, legal partner, parents, children, or siblings). Employees of Hengrui Company are also excluded.

Treatments Being Tested

DRUG

HRS9531

HRS9531

DRUG

HRS9531placebo

HRS9531placebo

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Beijing Hospital
Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06974851), the sponsor (Fujian Shengdi Pharmaceutical Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06974851 clinical trial studying?

A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects with Obstructive Sleep Apnea (OSA) and Obesity The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06974851?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06974851?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06974851. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06974851. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.