Novo Nordisk's Oral Weight-Loss Drug Shows Significant Benefit

Novo Nordisk A/S NVO announced headline results from OASIS 1 Phase 3a trial in the global OASIS program. 

OASIS 1 is a 68-week, efficacy, and safety trial comparing once-daily oral semaglutide 50 mg for weight management to a placebo in 667 adults with obesity or overweight with one or more comorbidities. 

Semaglutide is a peptide sold by Novo Nordisk under Ozempic, Rybelsus, and Wegovy for the long-term treatment of type 2 diabetes or obesity.

The trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss at week 68 with oral semaglutide 50 mg versus placebo.

Related: Mayo Clinic Study Highlights Potential of Novo Nordisk's Wegovy for Cardiac Health and Weight Loss.

When evaluating treatment effects, if all people adhered to treatment from a mean baseline body weight of 105.4 kg, people treated with oral semaglutide 50 mg achieved a statistically significant weight loss of 17.4% after 68 weeks compared to a 1.8% reduction with placebo.

In addition, 89.2% of those who received oral semaglutide 50 mg reached a weight loss of 5% or more after 68 weeks, compared to 24.5% with placebo.

When applying the treatment policy estimand, people treated with oral semaglutide 50 mg achieved a weight loss of 15.1% compared to a reduction of 2.4% with placebo, and 84.9% achieved a weight loss of 5% or more, compared to 25.8% with placebo.

In the trial, oral semaglutide 50 mg appeared to have a safe and well-tolerated profile. The most common adverse events were gastrointestinal; the vast majority were mild to moderate and diminished over time.

Novo Nordisk expects to file for regulatory approval in the U.S. and the EU in 2023. The global launch of oral semaglutide 50 mg is contingent on portfolio prioritisations and manufacturing capacity.

Price Action: NVO shares are up 0.13% at $170.77 on the last check Monday.