Fresh off of presenting eye-popping data for its obesity drug candidate semaglutide, Novo Nordisk is upping the ante with a more user-friendly version of the treatment.
The phase 3a program will enroll about 1,000 overweight participants and will examine the efficacy and safety of the oral treatment versus placebo. The study will kick off in the second half of this year.
Marketed as Ozempic, semaglutide is already in widespread use as a treatment for Type 2 diabetes. But the Danish company hopes to tap a much larger market as a treatment for obesity. Oral semaglutide is approved in Type 2 diabetes as Rybelsus.
“There is significant unmet medical need with obesity treatment today," Novo's executive VP of development Martin Holst Lange said in a statement. "With oral semaglutide we aim to introduce a convenient and effective treatment option."
Meanwhile, the injected version of semaglutide is already under regulatory review for obesity in the United States and Europe. Novo Nordisk expects a ruling from the FDA in the middle of this year, with Europe to follow in 2022.
The drug, an analog of the human glucagon-like peptide-1 hormone, induces weight loss by reducing hunger and increasing the feeling of fullness.
In February, Novo Nordisk released impressive results of a phase 3 trial of 1,961 adults who received a weekly 2.4 mg dose by self-injection. A third of patients lost more than 20% of their body weight over a 68-week period, with the average participant dropping 33 pounds, investigators found. In addition, many saw improvements in their risk factors for diabetes and heart disease.
The results were a "game-changer," study co-author Rachel Batterham of University College at London said at the time. Other experts were more reserved, noting that the drug causes gastrointestinal issues and that all studies of obesity drugs need to be considered over a longer period of time to determine true efficacy.
Shortly after Novo's semaglutide posted those impressive data, Eli Lilly's dual-action candidate tirzepatide out-performed the Novo medicine in reducing blood sugar levels and body weight in diabetes patients. In all, the data set the scene for a potentially interesting competition between Novo Nordisk and Lilly as they vie for diabetes patients and as Novo eyes separate obesity indications for its medicines.
Novo also markets a weight-loss shot Saxenda, a version of its older GLP-1 diabetes drug Victoza. That obesity medicine generated about $900 million in sales last year.