Novo Nordisk announced today that once-weekly GLP-1 agonist candidate semaglutide demonstrated weight loss efficacy in a phase 2 obesity study. The trial was completed in April 2017 according to ClinicalTrials.gov, ahead of previous estimations of 3Q17. The dose-escalation study compared up-titrated semaglutide (starting with a 0.05 mg dose) vs. Saxenda (liraglutide 3.0 mg) vs. placebo (all on top of diet/exercise) for 52 weeks. Data collection then continued out through a 7-week follow-up period. Mean baseline BMI for all participants was 39 kg/m2, and mean baseline body weight was 111 kg (~245 lbs). As per the topline data, semaglutide was associated with 13.8% weight loss vs. 2.3% in the placebo group. Weight loss for Saxenda-treated participants was reported to be consistent with prior SCALE studies, probably ~8%, but we’re eager to see more detail on the differential weight loss effects of semaglutide vs. high-dose liraglutide once the full results from this study are released. In general, semaglutide is thought to be a more potent GLP-1 agonist molecule vs. liraglutide, in terms of glucose-lowering and possibly weight loss as well. Novo Nordisk has submitted the candidate to the FDA and EMA for a type 2 diabetes indication (decisions expected by end of 2017), and is also investigating semaglutide in NASH (a common diabetes comorbidity, and a therapeutic area of high unmet need). We’re very pleased to note Novo Nordisk’s continued investment in obesity – as management shared on the company’s 1Q17 earnings call, only 2% of 600 million people with obesity worldwide are receiving medical treatment, so there’s plenty of room for innovation and expanding access to existing therapies. These positive results for semaglutide are not only exciting because of the potential for a new medicine, but because they could build awareness of pharmacotherapy as a viable treatment option for obesity.
-- by Payal Marathe and Kelly Close