This phase 2 trial included 211 Chinese participants with type 2 diabetes mellitus (mean age 48.4 years; 131 participants were male). Participants received once-weekly subcutaneous UBT251 (2 mg, 4 mg [initial dose 0.5 mg], 4 mg [initial dose 1 mg], or 6 mg), 1 mg semaglutide, or placebo for 24 weeks. At week 24, UBT251 achieved least-squares mean changes in glycated hemoglobin of -2.16% (95% CI, -2.39 to -1.92) to -1.98% (95% CI, -2.31 to -1.64), versus -1.77% (95% CI, -1.99 to -1.54) for semaglutide and -0.66% (95% CI, -0.90 to -0.41) for placebo (placebo-adjusted differences: -1.50% to -1.32%; all p < 0.001). UBT251 significantly reduced fasting blood glucose, 2-h postprandial glucose, and waist circumference versus placebo (all p < 0.001). Weight reduction with UBT251 was significantly greater than both placebo and semaglutide (all p < 0.05). Gastrointestinal events were the most common treatment-emergent adverse events. These findings support further phase 3 evaluation of UBT251. Registration: CTR20250029; NCT07163624.
