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Recruiting NCT06994650

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy

Phase III Interventional Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS9531, Placebo.
Who it may be relevant to
Registry conditions: Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This study is a phase 3 clinical trial, aiming to evaluate the efficacy and safety of HRS-9531 injection in obese subjects with obstructive sleep apnea (OSA) who are on positive airway pressure ventilation (PAP) therapy.

Interventions

  • Drug HRS9531
    HRS9531 will be administered by Subcutaneous injection
  • Drug Placebo
    Matching Placebo will be administered by Subcutaneous injection

Primary outcome measures

  • The change of AHI form baseline after 52 weeks of treatment [Time frame: 52 weeks]
Secondary outcome measures (4)
  • The percentage change in AHI from baseline after 52 weeks of treatment [Time frame: 52 weeks]
  • The percentage of subjects with ≥50% AHI reduction from baseline after 52 weeks of treatment; [Time frame: 52 weeks]
  • The percentage of subjects with AHI <5.0 events /h, or AHI ranging from 5.0 to 14.0 events/h and Epworth Sleepiness Scale (ESS) ≤10 after 52 weeks of treatment; [Time frame: 52 weeks]
  • The percent change in body weight from baseline after 52 weeks of treatment. [Time frame: 52 weeks]

Eligibility criteria

Inclusion criteria

  • Aged 18 -75 (inclusive), male or female Sex
  • BMI ≥28.0 kg/m2；
  • ≥3 months of diet/exercise control pre-screening with ≤5.0 kg weight fluctuation in prior 3 months.
  • Confirmed OSA diagnosis with screening PSG showing AHI ≥15.0 events/h.
  • ≥3 months of PAP therapy pre-screening with planned continuation; willingness to pause PAP ≥1 week before each PSG.
  • Females/males of childbearing potential must use highly effective contraception from consent until 2 months post-treatment, with no pregnancy/donation plans. Females require negative pregnancy test ≤3 days pre-randomization and non-lactating.

Exclusion criteria

  • Endocrine disorders significantly affecting weight (e.g., Cushing's syndrome, hypo-/hyperthyroidism) or monogenic/hereditary obesity syndromes excluded.
  • Diabetes mellitus (excluding gestational diabetes).
  • Prior/planned OSA-related major surgeries (e.g., tonsillectomy/adenoidectomy) that may affect breathing.
  • Have significant craniofacial abnormalities that may affect breathing at baseline
  • Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration
  • Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
  • Impaired gastric emptying (e.g., gastric bypass, pyloric stenosis)；Chronic use of GI motility-affecting drugs；Severe GI disorders (e.g., active PUD, IBD)；GI surgeries (except non-motility-affecting procedures)
  • Pancreatic disorders (acute/chronic pancreatitis, pancreatic injury)；Acute cholecystitis history；Symptomatic/treated gallbladder disease
  • Have used drugs or treatments that may cause significant weight gain or loss within 3 months
  • Investigator-determined unsuitability/unwillingness to pause PAP therapy for at least 1 week pre-PSG (e.g., safety/occupational/personal considerations).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University People's Hospital — Beijing

Identifiers

NCT: NCT06994650 · HRS9531-307

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗