Novo Nordisk and Eli Lilly showcased advancements in the development of oral GLP-1 treatments for Type II diabetes and obesity at the ADA Scientific Sessions in San Diego. The companies presented data demonstrating the progress of their investigational oral GLP-1 therapies, which offer potential benefits compared to the current routine of weekly injections for patients.
Novo Nordisk’s Phase III study, known as OASIS 1, focused on their high-dose oral semaglutide. The study revealed that obese patients experienced an average weight loss of 15% after 68 weeks of treatment, with 34% of participants achieving a 20% reduction in weight. These results are similar to the weight reductions observed with Novo Nordisk’s injected GLP-1 drugs.
Novo Nordisk already has an oral GLP-1 treatment called Rybelsus on the market, approved in 2019 for Type 2 diabetes at a 14 mg dose. In the OASIS trial, patients received a higher 50 mg dose of the treatment. Following a similar strategy to their injected treatments, Novo Nordisk plans to seek approval for the high-dose oral pill later this year. However, the exact timing of the launch has yet to be determined, according to Mico Guevarra, M.D., the company’s medical director.
Novo Nordisk faced challenges meeting the overwhelming demand for their other GLP-1 drugs, Ozempic and Wegovy, which are anticipated to generate $15.3 billion in sales this year. The company is actively working to increase production capacity to meet the demand.
The OASIS trial enrolled patients with a body mass index (BMI) of 30 or higher, or a BMI of 27 or higher with weight-related complications. Those on placebo experienced a weight loss of 2.4%, while those on the high-dose Rybelsus achieved a significant weight reduction of 15.1%. It is important to note that none of the patients in the study had diabetes.
Regarding adverse events, gastrointestinal effects were reported in 80% of patients receiving the high-dose Rybelsus compared to 46% in the placebo group. Novo Nordisk released initial trial results last month, and the complete version was published in The Lancet on Sunday.
During the ADA conference, Lilly unveiled findings from a phase 2 clinical trial of their weight-loss medication Orforlipron. The trial demonstrated average weight reductions ranging from 9% to 15% over a 36-week duration, varying according to the administered dose. The doses examined included 12 mg, 24 mg, 36 mg, and 45 mg. The results were published in The New England Journal of Medicine on Friday.