Core Viewpoint - The company has successfully completed Phase II clinical trials for its innovative drug UBT251 injection in overweight/obese patients in China, demonstrating significant weight loss and safety profile [1][2]. Group 1: Clinical Trial Details - The Phase II clinical study involved 205 participants with obesity (BMI ≥ 28.0 kg/m²) or overweight patients with at least one weight-related comorbidity (24.0 kg/m² ≤ BMI < 28.0 kg/m²) [1]. - Participants were randomly assigned in a 1:1:1:1 ratio to receive UBT251 injection at doses of 2 mg, 4 mg, or 6 mg, or a placebo, administered once weekly for 24 weeks [1]. - The primary endpoint was the percentage change in weight from baseline after 24 weeks of treatment [1]. Group 2: Results and Efficacy - After 24 weeks, the UBT251 treatment groups achieved a maximum average weight reduction of -19.7% (-17.5 kg), compared to -2.0% (-1.6 kg) in the placebo group [2]. - Significant improvements were also observed in secondary endpoints, including waist circumference, blood glucose, blood pressure, and blood lipids, all showing better results than the placebo [2]. Group 3: Safety and Next Steps - The overall safety and tolerability of UBT251 were good, with no participants dropping out due to adverse events, which were similar to those of comparable drugs and mostly mild to moderate gastrointestinal reactions [2]. - The successful Phase II results support the progression to Phase III clinical trials for UBT251 in overweight/obese patients in China [2].
联邦制药(03933)：UBT251 注射液已完成在中国超重/肥胖患者中的 II 期临床研究