
Once-weekly treatment with semaglutide is safe and induces weight loss in Asians with obesity, according to the phase III STEP 11 trial.
Conducted at multiple clinical sites in South Korea and Thailand, the trial included 150 diabetes-free Asian adults (mean age 39 years, 74 percent female) with a BMI of ≥25 kg/m2 (mean 31.3 kg/m2). These participants were randomly assigned to receive once-weekly subcutaneous treatment with semaglutide 2.4 mg (n=101) or placebo (n=49), alongside a reduced-calorie diet and increased physical activity, for 44 weeks.
Coprimary endpoints were percentage bodyweight change and the proportion of participants achieving ≥5-percent reduction in bodyweight. Secondary endpoints included the proportion of participants who achieved ≥10-percent and ≥15-percent bodyweight reductions and change in waist circumference.
At week 44, the semaglutide group showed a substantially greater mean change in bodyweight than the placebo group (−16 percent vs −3.1 percent; p<0.0001). Furthermore, significantly more semaglutide-treated participants achieved a bodyweight reduction of ≥5 percent (96 percent vs 25 percent; p<0·0001), ≥10 percent (78 percent vs 10 percent; p<0.0001), and ≥15 percent (53 percent vs 4.2 percent; p<0.0001).
Waist circumference decreased by 11.9 cm in the semaglutide group vs 3 cm in the placebo group (p<0.0001).
Adverse events (AEs) occurred in 89 percent of participants in the semaglutide group and 78 percent of those in the placebo group, including serious AEs in 13 and 8 percent, respectively. Gastrointestinal AEs were the most common AEs in the semaglutide group.