Novo Nordisk’s run of good news with GLP-1 agonist semaglutide has continued with a mid-stage trial showing it can achieve significant weight loss in adults with obesity.
The proof-of-principle trial showed that daily, subcutaneous injections of semaglutide helped obese adults lose up to 13.8% of their body weight in a year, compared to 2.3% in the placebo group.
Overall, 83% of patients treated with the drug lost 5% or more of their body weight, compared to 23% of the placebo arm and 66% with Novo’s shorter-acting GLP-1 drug Saxenda (liraglutide 3mg) as an active control. Two thirds (65%) of subjects on semaglutide experienced weight loss of 10% or more, compared to 10% with placebo and 34% with liraglutide.
Daily injections could be a hard sell for patients struggling with being overweight, but Novo intends to take its new once-weekly subcutaneous formulation of semaglutide – approved as Ozempic by the FDA last December – into a phase III obesity programme.
Novo has made no secret of its ambition in obesity and the potential of semaglutide to transform the largely unserved and under-penetrated weight loss market. It is estimated that only 7% of obese patients visit their doctor for help and only 2% receive treatment. Those that do get treatment typically only stay on it for a few months – likely because of disappointing results. The company hopes semaglutide can change that by keeping more patients on therapy for longer, but it also has a clutch of other drugs with different mechanisms of action in earlier-stage development.
The positive data in obesity is another boost for Novo as it tries to position semaglutide as a successor to Victoza, which pulled in $3.8bn in sales for the Danish drugmaker last year but is seeing its market share shrink thanks to new rivals such as Eli Lilly’s Trulicity (dulaglutide). Victoza’s patents are also being challenged by generic rivals – including Teva in the US – although Novo is claiming patent protection there until 2023.
Ozempic has not only outperformed Victoza in trials but also beat Trulicity in a head-to-head trial and demonstrated a benefit compared to placebo on cardiovascular outcomes in the SUSTAIN 6 trial – becoming one of only a handful of diabetes medications to achieve the latter objective including Victoza – although the data wasn’t deemed strong enough to support a label claim.
Meanwhile, Novo has also just reported positive late-stage results with an oral formulation of semaglutide, setting it on a path to possible filing in 2019 and rounding out what some analysts have described as a “portfolio in a drug” with semaglutide. Obesity and the oral form play a big part in that view, but semaglutide is also being tested in non-alcoholic steatohepatitis (NASH) – another big target indication.