Weight ManagementPhase 2NCT06565871
A Study of HRS9531 Injection in Obese Subjects With Obstructive Sleep Apnea
A Phase 2 study testing HRS9531 Injection in people with Weight Management, run by Fujian Shengdi Pharmaceutical Co., Ltd..
Trial summary
The purpose of this study is to evaluate the effect and safety of HRS9531 Injection in Obese Subjects with Obstructive Sleep Apnea Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Weight Management
- What is being tested?
- HRS9531 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, age 18-65(both inclusive) at the time of signing informed consent.
- At screening visit, BMI 24-42kg/m2(both inclusive)
- Self-reported Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months.
- At screening visit, AHI ≥15 and Obstructive Sleep Apnea on PSG
Who cannot join
- Endocrine disorders that may significantly affect body weight, or obesity or hereditary obesity syndrome due to a single gene mutation;
- Diabetes (except gestational diabetes)
- There are diseases that may require systemic glucocorticoid therapy during the study period
- Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of screening Visit .Inclusion of a participant with more minor ear, nose or throat surgery (for example, deviated septum) will be at the investigator's discretion.
- Previous or known history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine adenomatosis type 2 (MEN2)
- In or suspected of depression, bipolar disorder, suicidal tendencies, schizophrenia or other more serious mental illness;
Show all 11Show fewer
- Use of drugs or treatments that may lead to significant weight gain or loss within 3 months, use of stimulants and hypnotics, mirtazapine, opioids, trazodone within 3 months;
- Patients with a history of blood donation or blood loss ≥400 ml within 3 months prior to screening, or receiving blood transfusions within 3 months
- During the screening or before randomization ,laboratory examination meets the following conditions:
- Fasting blood glucose ≥7.0 mmol/L, or HbA1c ≥6.5%; Hemoglobin <100 g/L; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3× upper limit of normal range (ULN), total bilirubin (TBIL) ≥2.0×ULN; Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (calculated based on serum creatinine using CKD-EPI formula); Fasting triglyceride (TG) >5.64 mmol/L (500 mg/dl); calcitonin ≥50 ng/L; Blood amylase or lipase ≥3×ULN; Thyroid stimulating hormone (TSH) <0.4 or >6.0 mIU/L; Abnormalities in other laboratory tests that the investigator determines may affect the assessment of efficacy or safety;
- 10、The 12-lead electrocardiogram (ECG) examination revealed clinically significant abnormalities that the investigators determined may affect the safety of the subject and QTcF>450 ms; 11、Poor blood pressure control: systolic blood pressure ≥160 mmHg, or diastolic blood pressure ≥110 mmHg, or diastolic blood pressure ≥100mmHg and deemed unsuitable for study by investigator; 12、Clinically relevant medical behavior or psychiatric disorder (other than OSA), that is associated with insomnia or excessive sleepiness in the past and at the time of screening; 13、Severe infection, severe trauma, or major or large surgery within 1 month prior to screening 14、Malignancy of any organ system within 5 years, regardless of evidence of local recurrence or metastasis; 15、A known or suspected history of alcohol and/or drug abuse; 16、The presence of a serious hematological disorder; 17、Surgery is planned during the trial (except for minor surgery that the investigators believe will not affect the trial) 18、Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process; 19、In the investigator's judgment, there are circumstances (medical, psychological, social, or geographical factors, etc.) that affect subject safety or any other conditions that interfere with the evaluation of test results.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects With Obstructive Sleep Apnea (OSA)
The purpose of this study is to evaluate the effect and safety of HRS9531 Injection in Obese Subjects with Obstructive Sleep Apnea
- Conditions
- Weight Management
- Being tested
- HRS9531 Injection, Placebo Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS9531 InjectionDrug
Titration administration, SC
HRS9531 InjectionDrug
Titration administration, SC
Placebo InjectionDrug
SC
| Study group | Role | What they receive |
|---|---|---|
| HRS9531 Injection low dose | Experimental | Not described Receives: Drug: HRS9531 Injection |
| HRS9531 Injection high dose | Experimental | Not described Receives: Drug: HRS9531 Injection |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in body weight
Measured: Baseline,32week
Secondary outcomes (7)
Change from Baseline in Apnea-Hypopnea Index (AHI)
Measured: Baseline,32week
Proportion of subjects with weight loss of ≥5% from baseline after 32 weeks of treatment
Measured: Week 32
Proportion of subjects with weight loss of ≥10% from baseline after 32 weeks of treatment
Measured: Week 32
Proportion of subjects with weight loss of ≥15%from baseline after 32 weeks of treatment
Measured: Week 32
Change from Baseline in Body weight
Measured: Baseline,32week
Change from Baseline in BMI
Measured: Baseline,32week
Percentage change from baseline in AHI
Measured: Baseline,32week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study startAug 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 Weight ManagementStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- 108 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
- NCT06565871
- Sponsor's protocol ID
- HRS9531-206
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 22 Aug 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 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects With Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT06565871
- Acronym / sponsor ID
- HRS9531-206
- Conditions
- Weight Management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Aug 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.
The purpose of this study is to evaluate the effect and safety of HRS9531 Injection in Obese Subjects with Obstructive Sleep Apnea
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 |
|---|---|---|
| HRS9531 Injection low dose | Experimental | Drug: HRS9531 Injection |
| HRS9531 Injection high dose | Experimental | Drug: HRS9531 Injection |
| Placebo | Placebo comparator | Drug: Placebo Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects, age 18-65(both inclusive) at the time of signing informed consent.
- At screening visit, BMI 24-42kg/m2(both inclusive)
- Self-reported Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months.
- At screening visit, AHI ≥15 and Obstructive Sleep Apnea on PSG
Key exclusion criteria (11 listed)
- Endocrine disorders that may significantly affect body weight, or obesity or hereditary obesity syndrome due to a single gene mutation;
- Diabetes (except gestational diabetes)
- There are diseases that may require systemic glucocorticoid therapy during the study period
- Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of screening Visit .Inclusion of a participant with more minor ear, nose or throat surgery (for example, deviated septum) will be at the investigator's discretion.
- Previous or known history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine adenomatosis type 2 (MEN2)
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 |
|---|---|---|
| HRS9531 InjectionTitration administration, SC | Drug | HRS9531 Injection low dose |
| HRS9531 InjectionTitration administration, SC | Drug | HRS9531 Injection high dose |
| Placebo InjectionSC | Drug | Placebo |
Primary outcome
Percentage change from baseline in body weight
Time frame: Baseline,32week
7 secondary outcomes
Change from Baseline in Apnea-Hypopnea Index (AHI)
Time frame: Baseline,32week
Proportion of subjects with weight loss of ≥5% from baseline after 32 weeks of treatment
Time frame: Week 32
Proportion of subjects with weight loss of ≥10% from baseline after 32 weeks of treatment
Time frame: Week 32
Proportion of subjects with weight loss of ≥15%from baseline after 32 weeks of treatment
Time frame: Week 32
Change from Baseline in Body weight
Time frame: Baseline,32week
Change from Baseline in BMI
Time frame: Baseline,32week
Percentage change from baseline in AHI
Time frame: Baseline,32week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Weight Management
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Monthly Compared to Placebo in Chinese Adults With Overweight or Obesity
Obesity, Overweight
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
Active, not recruiting
Optimal Digital Weight Loss Treatment for Rural Individuals
Overweight and Obesity
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 Injection in people with Weight Management, 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 4 inclusion and 11 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 22 Aug 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. 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 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 from baseline in body weight (time frame: Baseline,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 22 Aug 2024.