Bstructive Sleep Apnea (OSA) and ObesityPhase 3NCT06974851

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

A Phase 3 study testing HRS9531 in people with Bstructive Sleep Apnea (OSA) and Obesity, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Bstructive Sleep Apnea (OSA) and Obesity
What is being tested?: HRS9531
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 140 participants
Where: 1 siteChina
Study dates: 25 Jul 2025to Dec 2026
Phase: Phase 3
Are there results?: Not yet: the study is under way

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The participant has provided informed consent and is willing and able to comply with the study protocol requirements to complete the study.
Age between 18 and 75 years, male or female, at the time of signing the informed consent form.
BMI ≥ 28.0 kg/m² at screening.
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.
Polysomnography (PSG) results at screening confirm OSA.
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.

Who cannot join

Laboratory Test Abnormalities:
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), or total bilirubin (TBIL) ≥ 2.0 × ULN.
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).
Thyroid-stimulating hormone (TSH) < 0.4 or > 6.0 mIU/L.
Other laboratory abnormalities judged by the investigator to potentially affect efficacy or safety assessments.
Clinically Significant ECG Abnormalities:

Show all 42Show fewer

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.
Poorly Controlled Blood Pressure:
Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg.
PHQ-9 Score ≥ 15:
Patient Health Questionnaire-9 (PHQ-9) score ≥ 15.
Medical History or Conditions Prior to Screening or Randomization:
Endocrine disorders or monogenic mutations causing obesity or hereditary obesity syndromes that may significantly affect weight.
Diabetes mellitus.
Diagnosis of central or mixed sleep apnea or Cheyne-Stokes respiration.
Respiratory or neuromuscular diseases judged by the investigator to potentially interfere with trial results.
Clinical abnormalities or diseases related to insomnia or excessive sleepiness (excluding OSA).
History of conditions affecting gastric emptying, long-term use of medications directly affecting gastrointestinal motility, severe gastrointestinal diseases, or prior gastrointestinal surgery.
History of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic/treatment-requiring gallbladder disease.
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).
Severe infections, significant trauma, or major/moderate surgery within 1 month prior to screening.
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.
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).
Presence or suspicion of depression, bipolar disorder, suicidal tendencies, schizophrenia, or other severe psychiatric disorders.
Known or suspected history of alcohol and/or drug abuse or drug addiction.
Acute or chronic hepatitis or other severe liver diseases (excluding non-alcoholic fatty liver disease).
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).
Autoimmune diseases requiring systemic corticosteroid or immunosuppressive therapy during the study period.
Medications or Treatments Prior to Screening:
Use of medications or treatments likely to cause significant weight gain or loss within 3 months prior to screening.
Medications or treatments judged by the investigator to potentially affect sleepiness assessments.
Prior or planned bariatric surgery (except liposuction performed more than 1 year ago).
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).
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.
Requirement for supplemental oxygen.
Other Exclusion Criteria:
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).
History of blood donation or blood loss ≥ 400 mL within 3 months prior to screening, or receipt of a blood transfusion within 3 months.
Planned surgery during the trial (except minor surgeries deemed by the investigator to not affect the trial).
Participants with mental incapacity or language barriers unable to fully understand or participate in the trial.
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.).
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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yadi Tang contact

0518-82342973

yadi.tang.yt37@hengrui.com

China1 site, 1 recruiting

Beijing Hospital
Beijing, Beijing Municipality, 100034
Lixin Guo
Recruiting

Other trials in China

About this study

Official title: 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

Conditions: Bstructive Sleep Apnea (OSA) and Obesity
Being tested: HRS9531, HRS9531placebo
Medical subject headings: Sleep Apnea, Obstructive, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HRS9531Drug
HRS9531
HRS9531placeboDrug
HRS9531placebo

Study groups in NCT06974851
Study group	Role	What they receive
Group 1: HRS9531	Experimental	Not described Receives: Drug: HRS9531
Group 2: HRS9531placebo	Placebo comparator	Not described Receives: Drug: HRS9531placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage Change in AHI from Baseline at Week 52 of Treatment
Measured: 52week

Secondary outcomes (9)

Changes in AHI Relative to Baseline After 52 Weeks of Treatment
Measured: 52week
Proportion of Subjects with AHI <5.0 events/h, or AHI 5.0-14.0 events/h with Epworth Sleepiness Scale (ESS) ≤10 at Week 52 of Treatment
Measured: 52week
Percentage Change in Body Weight from Baseline at Week 52 of Treatment
Measured: 52week
Change in Epworth Sleepiness Scale (ESS) Score from Baseline at Week 52 of Treatment
Measured: 52week
Proportion of Subjects Achieving ≥5%, ≥10%, ≥15%, and ≥20% Reduction in Body Weight from Baseline at Week 52 of Treatment
Measured: 52week
Change in Body Weight and Body Mass Index (BMI) from Baseline at Week 52 of Treatment
Measured: 52week
Change in systolic and diastolic blood pressure from baseline at Week 52 of treatment.
Measured: 52week
Proportion of subjects reporting improvement in Patient Global Impression of Severity (PGIS)-OSA categories (sleepiness, fatigue, snoring) at Week 52 of treatment.
Measured: 52week
Incidence of adverse events (AEs)
Measured: 52week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jul 2025Dec 2026

First posted16 May 2025
Study start25 Jul 2025
Primary completionDec 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bstructive Sleep Apnea (OSA) and ObesityStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 140 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06974851
Sponsor's protocol ID: HRS9531-306
Status last verified: Apr 2025
First submitted: 24 Apr 2025
Last updated: 17 Nov 2025
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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06974851
Acronym / sponsor ID: HRS9531-306
Conditions: Bstructive Sleep Apnea (OSA) and Obesity
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 140 participants (estimated)
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 25 Jul 2025 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 16 May 2025 (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.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group 1: HRS9531	Experimental	Drug: HRS9531
Group 2: HRS9531placebo	Placebo comparator	Drug: HRS9531placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

The participant has provided informed consent and is willing and able to comply with the study protocol requirements to complete the study.
Age between 18 and 75 years, male or female, at the time of signing the informed consent form.
BMI ≥ 28.0 kg/m² at screening.
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.
Polysomnography (PSG) results at screening confirm OSA.

Key exclusion criteria (42 listed)

Laboratory Test Abnormalities:
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.
Poorly Controlled Blood Pressure:
Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg.

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	Group 1: HRS9531
HRS9531placeboHRS9531placebo	Drug	Group 2: HRS9531placebo

Primary outcome

Percentage Change in AHI from Baseline at Week 52 of Treatment
Time frame: 52week

9 secondary outcomes

Changes in AHI Relative to Baseline After 52 Weeks of Treatment
Time frame: 52week
Proportion of Subjects with AHI <5.0 events/h, or AHI 5.0-14.0 events/h with Epworth Sleepiness Scale (ESS) ≤10 at Week 52 of Treatment
Time frame: 52week
Percentage Change in Body Weight from Baseline at Week 52 of Treatment
Time frame: 52week
Change in Epworth Sleepiness Scale (ESS) Score from Baseline at Week 52 of Treatment
Time frame: 52week
Proportion of Subjects Achieving ≥5%, ≥10%, ≥15%, and ≥20% Reduction in Body Weight from Baseline at Week 52 of Treatment
Time frame: 52week
Change in Body Weight and Body Mass Index (BMI) from Baseline at Week 52 of Treatment
Time frame: 52week
Change in systolic and diastolic blood pressure from baseline at Week 52 of treatment.
Time frame: 52week
Proportion of subjects reporting improvement in Patient Global Impression of Severity (PGIS)-OSA categories (sleepiness, fatigue, snoring) at Week 52 of treatment.
Time frame: 52week
Incidence of adverse events (AEs)
Time frame: 52week

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
Individual participant dataSharing planned: Undecided

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.

Yadi Tang contact

0518-82342973

yadi.tang.yt37@hengrui.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HRS9531 in people with Bstructive Sleep Apnea (OSA) and Obesity, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.

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 42 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: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yadi Tang (0518-82342973, yadi.tang.yt37@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 AHI from Baseline at Week 52 of Treatment (time frame: 52week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06974851.

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 17 Nov 2025.