Having recently proven itself in the randomised withdrawal setting, Novo Nordisk’s semaglutide has repeated the trick in a direct comparison against placebo. The Step 1 study has shown a 2.4mg daily dose of the GLP-1 agonist in its anti-obesity incarnation to deliver a knockout level of weight loss after 68 weeks’ treatment: 14.9% versus baseline, or 12.5% adjusted for weight loss seen in the placebo cohort. Last month the Step 4 study read out, showing 68-week weight loss of 17.4% from baseline. That trial had a randomised withdrawal design, with the first 20 weeks being on semaglutide before a 48-week placebo-controlled stage, during which placebo recipients regained an average 6.6kg of the 11.1kg they had lost during the run-in. At 1,950 subjects Step 1 is the biggest of Novo’s four pivotal studies reading out this year. Sellside consensus from EvaluatePharma shows 2026 forecast revenues of $1.7bn coming from semaglutide’s obesity use, with the vast majority of the remaining $12.3bn coming from its approved indication of type 2 diabetes. Historically obesity drugs have been scuppered by poor efficacy or unacceptable toxicity, and more on semaglutide’s “gastrointestinal events” is needed before declaring the Novo project an unequivocal winner.
|2020 obesity readouts for Novo Nordisk's semaglutide/Ozempic|
|Clinical study||Study details||Data|
|Step 4 (NCT03548987)||Maintaining weight loss: randomised withdrawal study (n=900)||At 20 weeks (sema run-in): 10.4% weight loss
After further 48 weeks: further 7.9% weight loss, vs 6.9% weight gain for placebo
|Step 1 (NCT03548935)||Weight management: semaglutide 2.4mg vs placebo (n=1,950)||At 68 weeks: 14.9% weight loss, vs 2.4% for placebo; ≥5% weight loss achieved by 92.4% of sema patients, vs 33.1% for placebo|
|Step 2 (NCT03552757)||Weight management in type 2 diabetes: semaglutide 1mg & 2.4mg vs placebo (n=1,200)||Expected|
|Step 3 (NCT03611582)||Maximising weight loss: semaglutide 2.4mg + intensive behavioural therapy vs placebo (n=600)||Expected|