6/29/23, 11:45 PM STEP 1 Pathway Feedback Search Clinical Topics Home Studies STEP 1 STEP 1 Disease Obesity Trial question What is the role of once-weekly semaglutide as an adjunct to lifestyle intervention in adults with overweight or obesity? Study design Multi-center Double blinded RCT Population Characteristics of study participants 66.2% female N = 1961 33.8% male 1961 patients (955 female, 498 male) Inclusion criteria: patients with a body-mass index of 30 (or 27 with 1 weight-related coexisting condition) who did not have diabetes Key exclusion criteria: HbA1c 6.5%, self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening, previous treatment with glucose-lowering agents or any antiobesity medications within the past 90 days before screening Interventions N=1306 semaglutide (2.4 mg once-weekly plus diet and physical activity counseling) N=655 placebo (matching placebo subcutaneous injection once-weekly plus diet and physical activity counseling) https://web.pathway.md/studies/recnfrfXWGE6Mioou 1/2 6/29/23, 11:45 PM STEP 1 Pathway Primary outcome Relative weight reduction at week 68 14.9 % 14.9 11.2 % 7.5 % Significant increase 3.7 % NNT = 8 2.4 0.0 % Semaglutide Placebo Significant increase in relative weight reduction at week 68 (14.9% vs. 2.4%; AD 12.4%, 95% CI 11.5 to 13.4) Secondary outcomes Significant increase in the percentage of patients achieving a weight reduction of 10% at week 68 (69.1% vs. 12%; OR 14.7, 95% CI 11.1 to 19.4) Significant increase in the percentage of patients achieving a reduction in weight by 15% at week 68 (50.5% vs. 4.9%; OR 19.3, 95% CI 12.9 to 28.8) Significant increase in absolute weight reduction from baseline to week 68 (15.3 kg vs. 2.6 kg; AD 12.7 kg, 95% CI 11.7 to 13.7) Safety outcomes No significant difference in overall adverse events. Significant differences in serious adverse events (9.8% vs. 6.4%), gastrointestinal disorders (74.2% vs. 47.9%), treatment discontinuation due to gastrointestinal events (4.5% vs. 0.8%). Conclusion In patients with a body-mass index of 30 (or 27 with 1 weight-related coexisting condition) who did not have diabetes, semaglutide was superior to placebo with respect to relative weight reduction at week 68. Reference John P.H. Wilding, D.M., Rachel L. Batterham et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Feb 10. Open reference URL https://web.pathway.md/studies/recnfrfXWGE6Mioou 2/2