Novo Nordisk announces positive phase 3 results for oral weight-loss drug

Novo Nordisk has announced positive results from a phase 3a trial of an oral, higher-dose formulation of its weight-loss drug.

Semaglutide is already available in major markets for weight management as a once-weekly injection. The drug, sold under the brand names Ozempic, Wegovy and Rybelsus, suppresses patients’ appetites by mimicking an intestinal hormone called GLP-1, which is released after eating.

The 68-week OASIS 1 study enrolled 667 adults who were either obese or overweight with at least one weight-related health condition to receive once-daily oral semaglutide 50mg or placebo.

For the overall treatment group, the mean weight loss from baseline was 15.1% in the semaglutide cohort, compared to 2.4% receiving placebo. Additionally, nearly 85% of patients receiving the drug lost at least 5% of their starting weight, compared to 25.8% on placebo.

The study also evaluated the effects of semaglutide on patients who adhered well to the treatment, with those in this subgroup achieving a weight loss of 17.1%, compared to 1.8% with placebo, and nearly 90% reaching a weight loss of 5%.

"The results show comparable weight loss as in the STEP 1 trial with injectable semaglutide 2.4mg in obesity branded as Wegovy,” explained Martin Holst Lange, executive vice president for development at Novo Nordisk.

”The choice between a daily tablet or weekly injection for obesity has the potential to offer patients and healthcare providers the opportunity to choose what best suits individual treatment preferences,” he added.

Novo Nordisk said it expects to file for regulatory approval for the 50mg oral formulation of the drug in the US and EU this year.

The Health Survey for England 2021 estimates that 25.9% of adults in England are obese and a further 37.9% are overweight, with the government estimating that the current costs of obesity in the UK are £6.1bn to the NHS and £27bn to wider society.

The once-weekly injection formulation of semaglutide was recommended by the National Institute for Health and Care Excellence in March for adults who are either obese or overweight with at least one weight-related health condition.

The following month, the European Medicines Agency’s human medicines committee recommended the drug for use in adolescents aged 12 years and older with obesity and a minimum weight of 60kg.