Just eight months after it introduced its oral version of semaglutide for obesity, also known as the Wegovy pill, Novo Nordisk is testing the GLP-1 in smaller doses in the late-stage OASIS 5 study.
The company has not made public the strength of the doses being tested in the placebo-controlled trial, which is underway in the United States and Europe. A starter dose of the Wegovy pill comes in at 1.5 mg, with the titration schedule ramping up at increments of 4 mg, 9 mg and then a maximum dose of 25 mg.
"OASIS 5 is designed to evaluate the efficacy and safety of lower maintenance doses of the Wegovy pill in adults with overweight or obesity," Novo said in an email to Fierce. "While the currently approved maintenance dose is 25 mg, we are also studying the effects of lower maintenance doses by generating new evidence to fully reflect the patients’ needs in real-world obesity management."
The study, which began last week, will include 450 patients who will be on treatment for 60 weeks. The trial is open to adults with a body mass index (BMI) of 30 or more or a BMI of 27 or more for those with a weight-related health issue such as hypertension, sleep apnea or cardiovascular disease. The study excludes diabetes patients and those who have recently lost weight or are already being treated with a GLP-1.
The primary objective of OASIS 5 is to investigate weight loss. Secondarily, the trial also will track blood pressure, cholesterol levels, waist circumference, side effects and other weight-related health metrics.
"Having a broader range of maintenance doses could provide greater flexibility in treatment and optimizing the patient experience," Novo added. "The study is therefore part of our ongoing work to build the clinical evidence required to support appropriate treatment options for people with obesity."
The company did not address a question about which doses are being studied.
The uptake of the Wegovy pill has been successful so far. In the second quarter, the oral drug clinched sales of 3.22 billion Danish kroner ($497 million), far outdistancing those of Eli Lilly’s GLP-1 pill Foundayo, which was launched in early April and accounted for sales of $98 million in the latest reported quarter.
Since GLP-1 weight-loss medicines were brought to the market by Novo Nordisk and Eli Lilly, some patients have been using smaller “microdoses” to manage the high costs or side effects of the treatments. This practice often dovetails with the use of compounded drug product, which Novo and Lilly have been fighting fiercely over the past several years.
Moreover, as additional weight loss candidates reach the pivotal stages of development, drugmakers are increasingly highlighting differences in the magnitude and quality of weight loss offered by their assets as potential differentiating factors in the high-demand and ever-evolving obesity market.
https://www.fiercepharma.com/pharma/novo-nordisk-kicks-trial-testing-smaller-doses-wegovy-pill
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