What if the cure for obesity was as simple as popping a pill?
It’s a notion that has long fueled hope for many of the more than 40% of Americans considered obese — and has fueled criticism by those who advocate for widespread weight acceptance. Soon, it could be a reality.
High-dose oral versions of the drug in the weight-loss drug Vegovy may work as well as popular injections when it comes to losing weight and improving health, according to the final results of two studies released Sunday night. The potent pills also work for people with diabetes, who are notorious for putting on weight.
Drug maker Novo Nordisk plans to ask the US Food and Drug Administration to approve the pills later this year.
“If you ask people a random question, ‘Would you rather take the pill or the injection?’ “People overwhelmingly prefer the pill,” said Dr. Daniel Bessein, chief of endocrinology at Denver Health, who treats obese patients but was not involved in the new research.
It is assumed that both ways of taking the drugs are equally effective, available and cost-effective, Bessen said. “Those are the most important factors for people,” he said.
There are other weight loss pills on the market, but none produce the substantial reductions seen with injectable drugs like Vegovi. People with obesity will be “thrilled” to have an oral option that’s just as effective, said Dr. Catherine Saunders, clinical professor of medicine at Weill Cornell Health and co-founder of the weight-loss center IntelliHealth.
Novo Nordisk already sells Ribelsus, which is approved to treat diabetes and is an oral version of semaglutide, the same drug used in the diabetes drugs Ozempic and Vegovy. It comes in doses of up to 14 mg.
But the results of two gold-standard trials, released at the annual meeting of the American Diabetes Association, looked at how oral semaglutide doses of up to 25 mg and 50 mg helped reduce weight and improve blood sugar and other health markers. Work done.
A 16-month study of nearly 1,600 people who were overweight or obese and already being treated for type 2 diabetes found that high-dose daily tablets lowered blood sugar significantly more than standard doses of ribulus . From a baseline weight of 212 pounds, the higher dose resulted in a weight loss of between 15 and 20 pounds compared to about 10 pounds at the lower dose.
Another 16-month study on more than 660 adults who were obese or overweight with at least one associated disease — but not diabetes — found that a 50-milligram daily pill helped people lose an average of their body weight. Helped to reduce the weight around 15% or so. 35 pounds, versus about 6 pounds with a dummy pill, or placebo.
The study authors said this is “particularly consistent” with the weight loss induced by weekly shots of the highest dose of Vegovy.
But it also had its consequences. About 80% of participants who received any size dose of oral semaglutide experienced mild to moderate gastrointestinal problems, such as nausea, constipation, and diarrhea.
In the 50 mg obesity trial, there was evidence of a higher rate of benign tumors in those who took the drug compared to placebo. In addition, about 13% of those taking the drug had “altered skin sensations” such as tingling or extra sensitivity.
Medical experts predict the pills will be popular, especially among people who want to lose weight but are afraid of needles. Also, the tablets would be more portable than injection pens and would not need to be stored in a refrigerator.
But the pills aren’t a better option for the thousands of people who are already taking injectable versions like Ozempic or Vegovy, said Dr. Fatima Cody Stanford, an obesity medicine specialist at Massachusetts General Hospital.
“I don’t see any particular hesitation in taking the injection,” he said. “Many people like the ease of taking the drug once a week.”
In addition, he said, some patients may actually prefer the shots instead of the new pills, which have to be taken in the morning, 30 minutes before eating or drinking.
Paul Maurer, 56, who works for a New Jersey hospital system, has lost 85 pounds using Wegovy and hopes to lose another 30 pounds. He said that even if pills were available, he would probably stick to weekly injections.
“I do it on Saturday mornings. It’s part of my routine,” he said. “I don’t even feel the needle. It’s not an issue.”
Some critics also worry that a pill would put pressure on people who are obese to use it as well, leading to social stigma against people who can’t — or don’t want to — lose weight. are, said Tigress Osborne, president of the national association. Advance Fat Approval.
“There’s no escaping the story that your body is wrong and needs to be changed,” Osborne said.
Still, Novo Nordisk is counting on the popularity of the high-dose pill to treat both diabetes and obesity. Rebellus’ sales reached nearly $1.63 billion last year, more than doubling that figure for 2021.
Other companies are working on oral versions of the drugs that also work, along with Eli Lilly & Co’s Monjaro — an injectable diabetes drug that is expected to be approved soon for weight loss. Lilly researchers report mid-stage trial results of an oral tablet called orforgalipron to treat obese or overweight patients with or without diabetes.
Pfizer has also released mid-stage results for dangulzipron, an oral drug taken twice daily with food for diabetes.
Novo Nordisk executives said it was too early to say what the firm’s high-dose oral tablets would cost or how the company plans to guarantee enough manufacturing capacity to meet demand. Company officials said that despite the growing popularity, injectable doses of Vegovy will remain in short supply until at least September.
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