[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase IIb clinical study to evaluate the efficacy and safety of MWN101 injection in obese subjects with moderate to severe obstructive sleep apnea (OSA)
主要目的:
评价不同剂量MWN101注射液在合并中重度阻塞性睡眠呼吸暂停(OSA)的肥胖受试者中降低体重的有效性。
次要目的:
评价不同剂量MWN101注射液在合并中重度阻塞性睡眠呼吸暂停(OSA)的肥胖受试者中缓解OSA的有效性;
评价MWN101注射液在合并中重度阻塞性睡眠呼吸暂停(OSA)的肥胖受试者中的免疫原性及安全性;
评价MWN101注射液在合并中重度阻塞性睡眠呼吸暂停(OSA)的肥胖受试者中的药代动力学特征。
探索MWN101注射液30 mg多次给药的安全性、耐受性和药代动力学特征。
[Translation] Primary objective:
To evaluate the effectiveness of different doses of MWN101 injection in reducing body weight in obese subjects with moderate to severe obstructive sleep apnea (OSA).
Secondary objectives:
To evaluate the effectiveness of different doses of MWN101 injection in relieving OSA in obese subjects with moderate to severe obstructive sleep apnea (OSA);
To evaluate the immunogenicity and safety of MWN101 injection in obese subjects with moderate to severe obstructive sleep apnea (OSA);
To evaluate the pharmacokinetic characteristics of MWN101 injection in obese subjects with moderate to severe obstructive sleep apnea (OSA).
To explore the safety, tolerability and pharmacokinetic characteristics of MWN101 injection after multiple administration of 30 mg.