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Novo Nordisk‘s high-dose experimental obesity pill helped overweight or obese adults lose around 15% of their body weight, according to new late-stage clinical trial results.
The Danish company presented the data at a diabetes conference Sunday. Novo Nordisk told Reuters it plans to file for Food and Drug Administration approval of the drug later this year.
Novo Nordisk is fighting to maintain its dominant position in the booming weight loss drug market as new competitors such as Eli Lilly and Pfizer develop their own effective treatments.
Novo Nordisk’s pill is an oral version of semaglutide, the active ingredient in the company’s blockbuster weight loss injections Ozempic and Wegovy. Semaglutide mimics a hormone produced in the gut called GLP-1, which signals to the brain when a person is full.
Novo Nordisk already has an FDA-approved oral semaglutide, which is marketed under the brand name Rybelsus for the treatment of type 2 diabetes. But the highest dose of Rybelsus is 14 milligrams, while the company’s experimental obesity pill has a far larger dose of 50 milligrams.
The phase three trial followed 667 obese and overweight adults who did not have Type 2 diabetes.
Patients who took 50 milligrams of the pill once a day for 68 weeks saw an average weight loss of 15.1%, when they used it alongside diet and physical activity, according to Novo Nordisk. That’s compared with a 2.4% weight loss for patients who took a placebo.
Around 85% of patients who took the pill lost at least 5% of their body weight, while only 26% of those who received the placebo did.
The weight loss also led to “improvements in physical functioning, allowing participants to have an improved quality of life for everyday activities,” Dr. Filip Knop, an endocrinology professor at the University of Copenhagen who worked on the study, said in a statement.
The new data suggests that the high-dose pill may be as effective as Novo Nordisk’s weekly Wegovy injection, which also resulted in roughly 15% weight loss after 68 weeks.
But a pill would serve as a far more convenient way to treat obesity.
Knop said offering the pill to the public would “allow people who struggle to lose weight with diet and physical activity alone to take this effective medication in a way that best suits them.”
Other companies are also developing oral weight loss treatments to appeal to those who don’t want weekly injections.
Overweight or obese patients who took Eli Lilly’s experimental pill orforglipron lost 14.7% of their body weight after 36 weeks, according to midstage clinical trial results the company released Friday.
Pfizer is also developing its own weight loss pill, called danuglipron, which patients take twice a day.
But the pharmaceutical giant on Monday said it would stop developing its other experimental oral drug, lotiglipron, due to elevated liver enzymes in patients.
Companies started focusing more on the weight loss industry after Novo Nordisk’s Ozempic and Wegovy catapulted to the national spotlight in recent years.
Social media influencers, Hollywood celebrities and even billionaire tech mogul Elon Musk have reportedly used the popular injections to get rid of unwanted weight.
That popularity sparked widespread shortages and an increase in cheaper knockoffs of the drugs.
Shortages and other factors such as high out-of-pocket costs without insurance or unpleasant side effects have forced some people to stop taking Ozempic or Wegovy. Many users have complained of a rebound in weight that’s difficult to control.
More than two in five adults have obesity, according to the National Institutes of Health. About one in 11 adults have severe obesity.
