Novo Nordisk on Monday released the results of its Phase 3 clinical trial for a daily oral form of semaglutide, which resulted in an average 15.1% body weight loss in individuals who received the treatment.
Semaglutide, a drug that mimics a hormone called glucagon-like peptide-1 to target areas of the brain that regulate appetite and food intake, has grown in popularity in recent months as an effective weight-loss treatment.
The drug is currently available in multiple forms. Ozempic, a diabetes treatment, and Wegovy, a higher dose of the drug approved for weight loss, are available as weekly injections. It is also available in a low-dose oral form for type 2 diabetes under the brand name Rybelsus.
On Monday, Novo Nordisk announced that its new daily oral form of semagludtide led to significant weight loss in individuals with obesity. In the trial, which included 667 adults diagnosed as overweight or obese, participants who received the oral treatment lost 15.1% of their body weight over 68 weeks. Meanwhile, those who received a placebo only lost 2.4% of their body weight.
According to Martin Holst Lange, EVP for development at Novo Nordisk, the results of the trial "show comparable weight loss as in the STEP 1 trial with injectable semaglutide 2.4 mg in obesity branded as Wegovy."
In an earlier clinical trial of Wegovy, patients lost an average of 14.9% of their body weight over 68 weeks, leading many experts to call it a "game-changer" for obesity treatments.
In both studies, Novo Nordisk noted that the most common side effect was mild to moderate gastrointestinal distress.
Novo Nordisk said it plans to submit oral semaglutide for approval in the United States and Europe later this year.
"We are very pleased with the weight loss demonstrated by the once-daily oral formulation of semaglutide in obesity," Lange said. "The choice between a daily tablet or weekly injection for obesity has the potential to offer patients and healthcare providers the opportunity to choose what best suits individual treatment preferences."
So far, Novo Nordisk is still dominating the weight loss drug market. However, it will soon be competing with Eli Lilly's Mounjaro — a treatment that is currently approved for diabetes that could result in more significant weight loss.
In addition, other drug manufacturers, like Pfizer and Amgen, are working on rival treatments that could be more potent, convenient, or tolerable, STAT+ reports.
Providing an oral option would give Novo Nordisk "the first safe, highly efficacious weight-loss pill ever marketed," according to TD Cowen analyst Michael Nedelcovych.
However, Novo Nordisk will need to be able to consistently meet demand if the drug is approved. The company has struggled to produce enough of its oral and injectable forms of semaglutide, with monthslong shortages in 2022.
While the company estimated that all doses would be available at the start of 2023, it recently paused advertising "to avoid stimulating further demand for this medicine." Then, the company earlier this month announced plans to limit starter doses for new patients to maintain a steady supply for those already taking the drug.
Ultimately, the commercialization of oral semaglutide is "contingent on portfolio prioritizations and manufacturing capacity," Novo Nordisk said in a statement. (Garde, STAT+ [subscription required], 5/22; Brueck, Insider, 5/22; Novo Nordisk news release, 5/22)
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