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Novo NordiskThe high-dose experimental obesity pill has helped overweight or obese adults lose about 15% of their body weight, new late-stage clinical trial results show.
The Danish company presented the data at a diabetes conference on Sunday. Novo Nordisk told Reuters that it plans to apply for Food and Drug Administration approval of the drug later this year.
Novo Nordisk is struggling 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 treatment methods.
Novo Nordisk’s pill is an oral version of semaglutide, the active ingredient in the company’s successful Ozempic and Wegovy weight-loss shots. Semaglutide mimics a hormone produced in the gut called GLP-1, which signals the brain when a person is full.
Novo Nordisk already has an FDA-approved oral semaglutide marketed under the brand name Rybelsus for the treatment of type 2 diabetes. But Rybelsus’ highest dose is 14 milligrams, while the company’s experimental obesity pill has a far higher dose of 50 milligrams.
The phase III study followed 667 obese and overweight adults who did not have type 2 diabetes.
According to Novo Nordisk, patients who took 50 milligrams of the pill once a day for 68 weeks saw an average weight loss of 15.1% when they added the pill to diet and exercise. This compares to a 2.4% weight loss in patients taking a placebo.
Around 85% of the patients taking the pill lost at least 5% of their body weight, compared to just 26% of those taking the placebo.
The weight loss also led to “improvements in physical performance, which allowed participants to have an improved quality of life in everyday activities,” said Dr. Filip Knop, a professor of endocrinology at the University of Copenhagen who worked on the study, in a statement.
The new data suggests the high-dose pill may be as effective as Novo Nordisk’s weekly Wegovy injection, which also resulted in about 15% weight loss after 68 weeks.
But a pill would be a far more convenient way to treat obesity.
Knop said offering the pill to the public would “give people who are struggling to lose weight through diet and exercise alone an opportunity to take this powerful drug in the 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 taking Eli Lilly’s experimental pill Orforglipron lost 14.7% of their body weight after 36 weeks, according to mid-stage clinical trial results the company released on Friday.
Pfizer is also developing its own weight loss pill called Danuglipron, which patients take twice a day.
But the pharma giant said Monday it was halting development of its other investigational oral drug, lotigliprone, due to elevated liver enzymes in patients.
After Novo Nordisk’s Ozempic and Wegovy took the spotlight nationwide in recent years, the companies have focused more on the weight-loss industry.
Social media influencers, Hollywood stars and even billionaire tech mogul Elon Musk have reportedly used the popular injections to shed unwanted weight.
This popularity led to widespread shortages and a proliferation of cheaper knockoffs of the drugs.
Bottlenecks and other factors such as high deductibles without insurance or unpleasant side effects have forced some people to stop taking Ozempic or Wegovy. Many users have complained of weight gain that is difficult to control.
According to the National Institutes of Health, more than two in five adults suffer from obesity. About one in eleven adults suffers from severe obesity.