FDA approves weight-loss drug after more than 50% of trial subjects shed at least 15% of body weight

The U.S. Food and Drug Administration on Friday approved Wegovy, a more potent version of an existing diabetes medication, as a weight-loss drug targeting chronic obesity after more than half of participants lost at least 15% of their body weight during a 68-week clinical trial.

The drug semaglutide has been marketed by Novo Nordisk since gaining FDA approval in 2019 to combat diabetes under the lower-dose brand names Ozempic and Rybelsus. However, the 2.4 mg dose of semaglutide approved Friday by the FDA is intended to address the chronic obesity affecting more than 40% of adult Americans, USA Today reported.

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Specifically, researchers at Chicago’s Northwestern University studied the drug’s impact on weight loss for nearly 2,000 individuals in 16 countries and published the results of the randomized and controlled late-stage clinical trial in the New England Journal of Medicine, ABC News reported.

Lisa Robillard, a 54-year-old lifelong dieter from Alexandria, Virginia, who was among one portion of the study’s roughly 800 participants, told USA Today that she lost 63 pounds during the 68-week trial.

“With the trial, that light went up. That was the first time I realized: ‘Wait a minute. This isn’t about willpower. There’s a physical aspect to this,’” Robillard told the outlet, noting she may finally have found a way to ditch her “roller coaster” history with ineffective fad diets.

According to ABC News, Wegovy reduces appetite and increases the feeling of fullness by mimicking a naturally occurring hormone that tells the brain when the body is full after a meal. The drug also slows down digestion, meaning food stays in the stomach longer.

Meanwhile, Dr. Robert Kushner, professor of medicine and medical education at Northwestern’s Feinberg School of Medicine, told USA Today that Wegovy is more effective than any other weight-management drugs on the market, which have shown average weight loss ranging between 5% and 12%.

According to USA Today, all 800 study participants lost an average of 10.6% of their body weight after taking Wegovy for 20 weeks. Participants were then separated into a randomized, controlled trial in which 535 continued to receive treatment and 268 were switched to a placebo.

Both groups maintained the same diet and exercise regimen, but participants who stayed on Wegovy continued to lose an average of 7.9% of their body weight, while those on the placebo gained an average of 6.9%, the outlet reported.

The injectable drug is administered once per week, as opposed to the daily regimen required by existing products, and at least one of the trial’s investigators, Kushner, characterized the Wegovy’s promise as a potential “game changer,” ABC News reported.

“We don’t use those terms lightly,” Kushner told the outlet, noting that in his 40-years in the field he has never seen a weight-loss drug candidate perform as strongly as Wegovy.

Specifically, the drug targets patients with a body mass index over 30, or a BMI over 27 with at least one weight-related comorbidity, the network reported.

According to the Novo Nordisk, Wegovy’s list price will be made public in the coming days; however, the company expects the price will be similar to that of its current anti-obesity medicine, Saxenda, which retails for $1,349.02 for a 30-day supply, ABC News reported.

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