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NCT Number: 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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

Fang Han

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

HRS9531

Drug

HRS9531 will be administered by Subcutaneous injection

Placebo

Drug

Matching Placebo will be administered by Subcutaneous injection

Primary outcomes

  1. The change of AHI form baseline after 52 weeks of treatment

    Time frame: 52 weeks

Secondary outcomes

  1. The percentage change in AHI from baseline after 52 weeks of treatment

    Time frame: 52 weeks

  2. The percentage of subjects with ≥50% AHI reduction from baseline after 52 weeks of treatment;

    Time frame: 52 weeks

  3. 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

  4. The percent change in body weight from baseline after 52 weeks of treatment.

    Time frame: 52 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Siai Sun

CONTACT

[email protected]

18036618062

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 29, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.