The potential advantages of a daily-pill version of popular GLP-1 drugs for Type 2 diabetes and obesity are obvious compared to the weekly injection routine most patients taking these drugs undergo.
Last weekend at the American Diabetes Association (ADA) Scientific Sessions in San Diego, market leaders Novo Nordisk and Eli Lilly presented data that showed their investigative oral GLP-1 treatments are making progress.
A phase 3 study of Novo Nordisk’s high-dose oral semaglutide, OASIS 1, shows that obese patients averaged a weight loss of 15% after 68 weeks of treatment, with 34% seeing a 20% drop in their weight. The results are comparable to the weight reductions seen with Novo’s injected GLP-1 drugs.
The company already has an oral GLP-1 on the market in Rybelsus, which was approved in 2019 for Type 2 diabetes at 7 mg and 14 mg doses. In the OASIS trial, patients received a 50mg version of the treatment.
Novo is following the same playbook it used with its injected treatments—gaining an approval for Ozempic in diabetes and then following on with its higher-dose version, Wegovy, to treat patients with obesity.
Novo said it plans to file for approval of the high-dose pill later this year but the company’s medical director, Mico Guevarra, M.D., told Reuters that timing of the launch is “to be determined.”
“We are upping production as much as we can,” Guevarra said, referring to the company’s previous difficulty in meeting the overwhelming demand for Ozempic and Wegovy, which are expected to generate $15.3 billion in sales this year.
In the OASIS trial—which included patients with a body mass index (BMI) of 30-plus or those with a BMI of 27-plus, with bodyweight-related complications—those on placebo lost 2.4% of their bodyweight compared to the 15.1% figure for high-dose Rybelsus. None of the patients in the study had diabetes.
As for gastrointestinal adverse events, 80% of patients on high-dose Rybelsus were affected versus 46% on placebo. Novo reported initial results from the trial last month. The complete version was published Sunday in The Lancet.
The data reinforced results from the PIONEER PLUS phase 3 study, which was designed primarily to see if diabetes patients—regardless of their weight—fared better on higher doses of Rybelsus. In addition to the trial meeting its primary endpoint, it also showed that it helped patients lose weight.
Also at the ADA conference, Lilly presented results from a phase 2 trial of its weight-loss pill orforlipron, which produced average weight losses of between 9% and 15% depending on the dose provided over a 36-week period. Doses tested were 12 mg, 24 mg, 36 mg and 45 mg. Results were published Friday in The New England Journal of Medicine.