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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	HRS9531	HRS9531 will be administered by Subcutaneous injection
DRUG	Placebo	Matching Placebo will be administered by Subcutaneous injection

Timeline

• Start date: 2025-08-13
• Primary completion: 2026-12-01
• Completion: 2027-01-01
• First posted: 2025-05-29
• Last updated: 2026-01-26

Locations

1 site across 1 country: China