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

Recruiting Phase 3 Interventional Study
Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
140 (estimated)
Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd. · Industry
Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
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.

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: 1. Aged 18 -75 (inclusive), male or female Sex 2. BMI ≥28.0 kg/m2; 3. ≥3 months of diet/exercise control pre-screening with ≤5.0 kg weight fluctuation in prior 3 months. 4. Confirmed OSA diagnosis with screening PSG showing AHI ≥15.0 events/h. 5. ≥3 months of PAP therapy pre-scr…
Contacts

Siai Sun

18036618062

siai.sun@hengrui.com

CONTACT