RecruitingPhase 3NCT06994650

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


Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Enrollment

140 participants

Start Date

Aug 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 clinical trial tests an experimental injectable medication called HRS-9531 to see if it reduces the severity of obstructive sleep apnea (OSA) in adults who are obese and already using a CPAP or similar breathing device. OSA causes repeated pauses in breathing during sleep, and excess weight is a major contributing factor; this drug targets weight-related mechanisms that may also affect airway function. Eligible participants are adults aged 18–75 with a BMI of 28 or higher, confirmed moderate-to-severe OSA, and at least 3 months of ongoing CPAP therapy, without diabetes or major upper airway abnormalities. Participation involves receiving injections of the study drug or a placebo over a treatment period, along with sleep studies and regular clinical visits. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHRS9531

HRS9531 will be administered by Subcutaneous injection

DRUGPlacebo

Matching Placebo will be administered by Subcutaneous injection


Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT06994650