[Translation] A randomized, double-blind, placebo-controlled phase IIb clinical study to evaluate the efficacy and safety of ABP2111Na tablets in overweight/obese participants
主要目的:
评价超重/肥胖参与者口服ABP2111Na片后的有效性; 次要目的: 1)评价超重/肥胖参与者口服ABP2111Na片后的安全性;
2)评价超重/肥胖参与者口服ABP2111Na片的群体药代动力学(PK)特征;
3)探索ABP2111Na片治疗超重/肥胖的最佳剂量;
探索性目的:
1)探索超重/肥胖参与者口服ABP2111Na片后药效学相关指标的变化;
2)探索超重/肥胖参与者口服ABP2111Na片后对脂肪性肝病相关指标的影响。
[Translation] Primary purpose:
To evaluate the effectiveness of ABP2111Na tablets after oral administration in overweight/obese participants; Secondary purpose: 1) To evaluate the safety of ABP2111Na tablets after oral administration in overweight/obese participants;
2) To evaluate the population pharmacokinetic (PK) characteristics of ABP2111Na tablets after oral administration in overweight/obese participants;
3) To explore the optimal dose of ABP2111Na tablets for the treatment of overweight/obesity;
Exploratory purpose:
1) To explore the changes in pharmacodynamic-related indicators after oral administration of ABP2111Na tablets in overweight/obese participants;
2) To explore the effects of ABP2111Na tablets on fatty liver disease-related indicators in overweight/obese participants.