Daily oral semaglutide shows strong results in weight loss trial

The OASIS 4 phase three trial has confirmed the safety and effectiveness of once-daily oral semaglutide 25 mg for weight management in adults living with overweight or obesity.

The findings, first presented at Obesity Week 2024, were published on 17 September in The New England Journal of Medicine.

The US Food and Drug Administration is due to decide later this year on Novo Nordisk’s application to approve the oral formulation for long-term weight control. If granted, it would be the first GLP-1 treatment available in pill form.

“This approval should change and enhance the practice of obesity medicine. Pills are easier to make and distribute than injectables requiring refrigeration,” said OASIS 4 investigator Dr Sean Wharton of the University of Toronto.

The trial involved 307 adults living with type 2 diabetes and obesity, who were randomly assigned to receive semaglutide 25 mg or placebo alongside lifestyle support.

After 64 weeks, those who adhered to treatment lost an average of 16.6 per cent of body weight compared with 2.7 per cent in the placebo group (P < .0001). Across all participants, average weight loss was 13.6 per cent versus 2.2 per cent, respectively (P < .001).

Weight reduction was also more likely in the semaglutide group. 79.2 per cent lost at least five per cent of body weight compared with 31.1 per cent on placebo. Similar differences were seen at higher weight loss thresholds.

Those taking semaglutide also saw improvements in physical function and risk factors such as BMI, waist circumference, blood glucose, insulin and lipids. Most with prediabetes at baseline returned to normal blood sugar levels.

Side effects were common but mostly mild or moderate, with gastrointestinal symptoms reported in 74.0 per cent of the semaglutide group and 42.2 per cent of those on placebo.

Researchers concluded that oral semaglutide 25 mg offers a promising new option for obesity treatment.

“This is going to change practice. If you prefer a pill, you will have the option,” Wharton said.

The trial was funded by Novo Nordisk.