Treating obesity may soon be as easy as taking a daily pill. Drugmaker Novo Nordisk plans to ask the U.S. Food and Drug Administration (FDA) to approve their semaglutide (Wegovy) pills later this year. The results of two recent studies showed that taking high-dose pills daily may be as effective as the once- weekly injection in people with Type 2 diabetes who are also overweight.
There have been other pills for weight loss in the past, but they didn’t come close to being as effective as injectable semaglutide for significant weight loss. Novo Nordisk already sells Rybelsus, which is also semaglutide but in oral form, for the treatment of Type 2 diabetes. The maximum dose is 14 milligrams.
The results of two drug trials were presented at the American Diabetes Association’s annual meeting. The studies examined doses of oral semaglutide at 25 milligrams and 50 milligrams, for weight loss and blood sugar control.
A 16-month study of about 1,600 people who were overweight and already being treated for Type 2 diabetes found that the high-dose daily pills regulated blood sugar significantly better than Rybelsus. The participants lost significantly more weight (15-20 pounds) on the high dose pills than on the lower dose pills (10 pounds).
Researchers also completed another 16-month study of more than 660 overweight adults with at least one related disease but not Type 2 diabetes. They found that the 50-milligram daily pill helped people lose an average of about 15 percent of their body weight, versus about six pounds with a placebo.
According to the researchers, the results were consistent with the weight loss by weekly injections of the highest dose of Wegovy.
“All of these medications work by teaching that hormonal axis between the brain and the gut — the way your brain tells the digestive system, ‘Look, you’ve had enough’ — it is those hormones that these medications are impacting. They’re also impacting your blood sugar levels,” explains CBS News medical contributor Dr. Céline Gounder in a June 2023 report.
There were side-effects
About 80 percent of participants receiving any size dose of oral semaglutide experienced nausea, vomiting, and constipation or diarrhea. About 10 percent of the higher-dose pill users had to stop the drug because the nausea was so severe.
“There are some downsides here. From the people that I know who’ve been on these medications, they describe it as feeling like they’re sick all the time, like when you’ve overeaten,” Gounder says. “So, you’re losing weight, but you’re not necessarily feeling great when you’re doing it.”
Weight is regained when the drug is stopped. Blood sugar may spike, and be accompanied by other symptoms of diabetes, such as blurry vision and excessive thirst. Long-term effects of the semaglutides are unknown. There is concern about effects on the liver and pancreas, and the possibility of cancers.
Medical experts predict the pills will be popular, especially among people who want to lose weight but are fearful of needles. Plus, tablets are more portable than injection pens and they do not have to be stored in the refrigerator.
Cost of medications is a concern and insurance coverage is uncertain. Forty percent of Americans are obese, according to the CDC. The injectable form of semaglutide costs about $15,000 per year. Therefore, costs could be in the trillions. It is likely that insurance will be extremely strict about who they cover.
Novo Nordisk officials said it is too early to say what the cost of the firm’s high-dose oral pills would be or how the company plans to guarantee adequate manufacturing capacity to meet demand.
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