Semaglutide repeats the obesity trick

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

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