Novo Nordisk oral weight loss drug shines in phase 3 trial

May 26, 2023

Denmark-based drugmaker Novo Nordisk announced earlier this week that its phase 3a trial evaluating the oral formulation of its weight loss drug had met its all primary endpoints.

The OASIS program, which evaluates the safety and efficacy of Novo's once-daily oral semaglutide 50 mg for weight management when compared to placebo, is a phase 3 clinical program that enrolled close to 1,300 adults over four trials. According to the recently shared results, patients treated with oral semaglutide 50 mg achieved a statistically significant weight loss of 17.4% or 40.3 lbs. after 68 weeks, compared to a 1.8% reduction or 4.2 lbs. with placebo. 

Additionally, 89.2% of those who received the drug reached a weight loss of 5% or more, equivalent to 21.4 lbs. or more, after 68 weeks, compared to 24.5% with placebo.

Martin Holst Lange, executive vice president for development at Novo Nordisk, emphasized the company’s enthusiasm for the drug reformulation, “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.”

Novo Nordisk hopes to file for regulatory approval for the drug in the U.S. and Europe this year.

Weight loss drugs are basking in the spotlight, with more than 5 million people receiving prescriptions for them in 2022, a 2082% increase from the 230,000 patients in 2019. Companies like Eli Lilly are developing their own or expanding indications for diabetes drugs to include weight loss management, which some analysts say could usurp Humira to become the best-selling drug of all time. According to UBS analyst Colin Bristow, Eli Lilly's tirzepatide is expected to generate annual sales of $25 billion — a figure that would exceed the previous record of $20.7 billion set by AbbVie's Humira in 2021.