Regulatory Decision Summary for Wegovy

Authorization was based on 4 Phase 3, double-blind, placebo-controlled, randomized controlled trials in patients who are obese (BMI ≥30) or overweight (BMI ≥27) with comorbidities, as add-on treatment to diet and increased physical activity. The Phase 3 trials included a total of 4182 patients, of which 2652 received treatment with the target maintenance dose for semaglutide of 2.4 mg/week for 52 weeks, following a 16-week dose escalation phase (68 weeks total). The primary or co-primary endpoint in each study was percent body weight loss from baseline at Week 68. Each study demonstrated a statistically significantly greater amount of weight loss in semaglutide-treated as compared to placebo-treated subjects. There were also significantly greater proportions of semaglutide-treated subjects with achievement of weight loss thresholds (≥5%, ≥10%, and ≥15% body weight loss) and improvements in cardiometabolic endpoints (e.g., systolic blood pressure, blood lipids).

The most common adverse events (>10%) that occurred more frequently in semaglutide-treated patients were gastrointestinal disorders (73%, including nausea, vomiting, diarrhea, abdominal pain, constipation, and hemorrhoids), headache (16%), and fatigue (11%). Overall, the risks for Wegovy were generally similar to those previously identified for the two other authorized semaglutide products, Ozempic (semaglutide injection) and Rybelsus (semaglutide tablets).

The recommended dose regimen for Wegovy involves a 16-week dose escalation phase in which patients receive 4 weeks treatment with doses of 0.25 mg/week, 0.50 mg/week, 1.0 mg/week, and 1.7 mg/week before reaching the target maintenance dose of 2.4 mg/week. The dose escalation protocol is intended to decrease the incidence and/or severity of the gastrointestinal side effects of semaglutide. View the Product Monograph for details.