Phase III STEP 3 trial of Ozempic shows weight loss in obesity.- Novo Nordisk

Results of a phase IIIa trial showed that investigational drug Ozempic (semaglutide 2.4 mg) once-weekly subcutaneous, from Novo Nordisk, as an adjunct to intensive behavioural therapy (IBT) demonstrated significantly more body weight loss compared to placebo plus IBT. The STEP 3 phase IIIa trial investigated the efficacy and safety of once-weekly semaglutide 2.4 mg after 68 weeks of treatment compared with placebo both as adjunct to IBT, which consisted of 30 counselling sessions with a registered dietitian over 68 weeks, plus a reduced-calorie diet and increased physical activity. Trial participants were adults with obesity (BMI at least 30 kg/m2) or overweight (BMI at least 27 kg/m2) with at least one weight-related co-morbidity and without type 2 diabetes (HbA1c <6.5%). two distinct statistical approaches to evaluating the effects of semaglutide 2.4 mg were used in the step 3 trial; a primary statistical approach that assessed the treatment effect regardless of adherence or use of other anti-obesity therapies, and a secondary statistical approach that evaluated the treatment effect if all participants in the trial adhered to the randomised treatment and did not initiate any other treatment methods. based on the primary statistical approach, people treated with once-weekly semaglutide 2.4 mg in addition to ibt lost an average of 16.0% of their body weight from baseline, compared with 5.7% for those who received placebo plus ibt (estimated treatment difference: -10.3 [95% confidence interval: -12.0, -8.6]; p><0.0001). furthermore, more people treated with semaglutide 2.4 mg plus ibt lost greater than or equal to 5% of their body weight compared to placebo plus ibt (87% vs 48%, respectively). a weight loss of greater than or equal to 10%, 15% and 20% was achieved by 75%, 56% and 36% of those treated with semaglutide 2.4 mg plus ibt respectively, compared to 27%, 13% and 4% of those treated with placebo plus ibt. in this trial, semaglutide 2.4 mg plus ibt also demonstrated greater improvements in cardiometabolic risk factors, including waist circumference (-14.6 vs. -6.3 cm) and blood pressure (-5.6 vs. 1.6 mmhg), compared to placebo plus ibt. when evaluating the effects of treatment based on the secondary statistical approach, people treated with semaglutide 2.4 mg plus ibt achieved an average weight loss of 17.6%, compared to 5.0% with placebo plus ibt. additionally, 90% of those who received semaglutide 2.4 mg plus ibt achieved a weight loss of 5% of more after 68 weeks, compared to 50% with placebo plus ibt. an oral presentation of the new data was given at the obesityweek 2020 interactive congress.>