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The estimated mean change in body weight from baseline to week 68 was -13.2% in the semaglutide 2.4 mg group versus -2.1% in the placebo group.
New findings suggest patients with obesity, with or without type 2 diabetes (T2D), receiving semaglutide 2.4 mg once a week had superior reductions in body weight and greater reduction in abdominal visceral fat, compared with placebo.
Study data show the estimated mean change in body weight from baseline to week 68 was -13.2% in the semaglutide 2.4 mg group and -9.6% in the semaglutide 1.7 mg group versus -2.1% in the placebo group.
Corresponding author Takashi Kadowaki, MD, Toranomon Hospital, noted the results represented “a promising treatment option for weight management in this population.”
The data was collected from the Semaglutide Treatment Effect in People with obesity (STEP) 6 trial that assessed the effect of semaglutide for weight management in adults from East Asia with placebo. STEP 6 was a randomized, double-blind, phase 3a trial performed at 28 outpatient clinics on eligible adults aged ≥18 years in South Korea and ≥20 years in Japan.
Further inclusion criteria included a BMI of at least 27.0 kg/m2 with ≥2 weight-related comorbidities or a BMI of 35.0 kg/m2 or more with ≥1 weight-related comorbidity who had at least one self-reported unsuccessful dietary attempt to lose bodyweight.
Patients were then randomly assigned (4:1:2:1) to once-weekly subcutaneous semaglutide 2.4 mg or matching placebo, or semaglutide 1.7 mg or matching placebo and lifestyle recommendations for 68 weeks.
Primary endpoints were the percentage change in body weight from baseline at week 68 and the proportion of individuals who achieved a reduction of ≥5% of baseline body weight at week 68. Then, the supportive secondary endpoint included the change in abdominal visceral fat area using computed tomography scanning. Both efficacy and safety outcomes were assessed by investigators.
From January 2019 - June 2019, a total of 437 patients were screened and 401 were randomly assigned to semaglutide 2.4 mg (n = 199), semaglutide 1.7 mg (n = 101), or placebo (n = 101) and included in the intention-to-treat analysis.
Kadowaki and colleagues observed at week 68, a larger proportion of patients had achieved a 5% or greater reduction in baseline body weight in the semaglutide 2.4 mg group (160 of 193, 83%) and semaglutide 1.7 mg group (71 of 98, 72%), compared to the placebo group (21 of 100, 21%).
Data the odds ratio was 21.7 (95% CI, 11.3 - 41.9) for semaglutide 2.4 mg versus placebo and an odds ratio of 11.1 (95% CI, 5.5 - 22.2) for semaglutide 1,7 mg versus placebo (both P <.0001).
Additionally, abdominal visceral fat was reduced by 40.0% in the semaglutide 2.4 mg group and 22.2% in the semaglutide 1.7 mg group versus 6.9% in the placebo group. Data show the estimated treatment difference was -33.2% (95% CI, -42.1 to -24.2) for semaglutide 2.4mg and -15.3% (95% CI, -25.6 to -4.9) for semaglutide 1.7 mg, compared to placebo.
Adverse events were reported in 17 of 199 (86%) in the semaglutide 2.4 mg group, 82 (82%) of 100 participants in the semaglutide 1.7 mg group, and 80 of 101 (79%) participants in the placebo group.
Adverse events leading to trial product discontinuation occurred in 5 of 199 (3%) participants in the semaglutide 2.4 mg group, 3 of 100 (3%) in the semaglutide 1.7 mg group, and 1 of 101 (1%) in the placebo group.
The study, “Semaglutide once a week in adults with overweight or obesity, with or without type 2 diabetes in an east Asian population (STEP 6): a randomized, double-blind, double-dummy, placebo-controlled, phase 3a trial,” was published in The Lancet Diabetes & Endocrinology.