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Novo Nordisk‘s high-dose experimental obesity pill helped overweight or obese adults lose about 15% of their body weight, according to new results of late-stage clinical trials.
The Danish company presented the data on a diabetes conference Sunday. Novo Nordisk told Reuters it plans to file for Food and Drug Administration approval for the drug later this year.
Novo Nordisk fights to maintain its dominant position in the fast-growing 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 that sends a signal 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 much larger dose of 50 milligrams.
The phase three study 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 used alongside diet and exercise, according to Novo Nordisk. That is compared to a 2.4% weight loss for patients taking a placebo.
About 85% of patients taking the pill lost at least 5% of their body weight, while only 26% of those taking the placebo did so.
The weight loss also led to “improvements in physical function, giving participants a better quality of life for daily activities,” says Dr. Philip Buttona professor of endocrinology 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 Wegovy weekly injection, which also resulted in about 15% weight loss after 68 weeks.
But a pill would be a much easier way to treat obesity.
Knop said offering the pill to the public “allows people who struggle to lose weight with diet and exercise alone to take this effective drug in a way that works best for 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 or forglipron lost 14.7% of their body weight after 36 weeks, according to interim clinical trial results released by the company on Friday.
Pfizer is also developing its own weight-loss pill called danuglipron, which patients take twice a day.
But the pharmaceutical giant said it did on Monday stop developing the other experimental oral drug, lotigliprone, due to elevated liver enzymes in patients.
Companies started to focus more on the weight loss industry after Novo Nordisk’s Ozempic and Wegovy rose to the national spotlight in recent years.
Social media influencers, Hollywood celebrities and even billionaire tech tycoon Elon Musk have reportedly used the popular injections to shed unwanted weight.
That popularity led to widespread shortages and an increase in cheaper imitations of the drugs.
Shortages and other factors such as high out-of-pocket costs without insurance or nasty side effects have forced some people to stop taking Ozempic or Wegovy. Many users have complained of a rebound in weight that is difficult to control.
More than two in five adults are obese, according to the National Health Institutes. About one in 11 adults is severely obese.