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

ConditionSubjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

HRS9531
Placebo

Treatment groups

140 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Fujian Shengdi Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov