Diabetes and weight loss juggernaut Novo Nordisk has presented data from a phase 3 trial that show an oral version of its obesity drug Wegovy performs comparably to its original injected therapy.
In the study, patients who received a 50 mg daily dose of the treatment lost an average of 15.1% of their weight over 68 weeks, compared with a 2.4% average weight loss for those on placebo. The trial, dubbed OASIS I, enrolled 667 adults with one or more comorbidities and an average starting weight of 105.4 kilograms (232 pounds).
“The choice between a daily tablet or weekly injection for obesity has the potential to offer patients and healthcare providers the opportunity to choose which suits individual treatment preferences,” Martin Holst Lange, the company’s executive vice president of development, said in the company's release.
Demand for injectable Wegovy has been so high—since its approval in June of 2021—that Novo has struggled to supply it. The company recently told Fierce Pharma that it has put promotional efforts on hold “to avoid stimulating further demand” for Wegovy.
Already, the GLP-1 treatment has become a social media sensation as it has been touted by celebrities, including Twitter CEO Elon Musk, for its ability to help them shed unwanted pounds.
As for the oral version, the company said it plans to file for approvals in the United States and Europe later this year. The potential launch is “contingent on portfolio prioritizations and manufacturing capacity,” Novo said.
This is not Novo’s first oral treatment in its semaglutide franchise. Rybelsus, which was approved in 2019, is an option to the company’s injected type 2 diabetes therapy Ozempic and remains the only GLP-1 pill on the market for diabetes. The drug, which is available in doses of 3, 7 and 14 mg, racked up sales of $1.7 billion last year, more than doubling its revenue from 2021.
Meanwhile, sales of Wegovy reached $913 million last year and $666 million in the first quarter of this year. Ozempic, which was approved in 2017 and has gained off-label use for weight loss, clocked in with sales of $8.6 billion in 2021.
In OASIS 1, Novo said that if all participants had adhered to treatment, the results would have been more dramatic, with an average weight loss of 17.4% for those on Wegovy and 1.8% for placebo patients. Additionally, 89% of semaglutide patients had a weight loss of 5% or more.
The trial “confirms Novo’s leadership in the indication,” analysts with ODDO BHF said in a note to investors.
“These results grow Novo Nordisk’s expertise as well as its scope of action in controlling obesity,” the ODDO BHF team added.
Novo’s primary semaglutide rival, Eli Lilly, won approval for its diabetes treatment Mounjaro 12 months ago. The GLP-1/GIP agonist also has been fast-tracked by the FDA as a therapy for obesity.
Last month, Lilly quietly registered a new trial that will compare the weight loss effects of Mounjaro against Wegovy in 700 patients.