What if treating obesity could be as easy as popping an effective pill?
That’s a notion that has long fueled hope for many of the more than 40% of Americans who are considered obese — and fueled criticism by those who advocate for wider weight acceptance. Soon, it may be a reality.
High-dose oral versions of the medication in the weight-loss drug Wegovy may work as well as the popular injections when it comes to paring pounds and improving health, according to final results of two studies released Sunday night. The potent tablets also appear to work for people with diabetes, who notoriously struggle to lose weight.
Drugmaker Novo Nordisk plans to ask the U.S. Food and Drug Administration to approve the pills later this year.
“If you ask people a random question, ‘Would you rather take a pill or an injection?’ People overwhelmingly prefer a pill,” said Dr. Daniel Bessesen, chief of endocrinology at Denver Health, who treats patients with obesity but was not involved in the new research.
That’s assuming, Bessesen said, that both ways to take the medications are equally effective, available and affordable. He said that these are factors people should consider.
There have been other weight-loss pills on the market, but none that achieve the substantial reductions seen with injected drugs like Wegovy. People with obesity will be “thrilled” to have an oral option that’s as effective, said Dr. Katherine Saunders, clinical professor of medicine at Weill Cornell Health and co-founder of Intellihealth, a weight-loss center.
Novo Nordisk sells Rybelsus which has been approved for diabetes treatment and is the oral form of semaglutide. This medication is also used to make the diabetes drugs Ozempic and Wegovy. It comes in doses up to 14 milligrams.
But results of two gold-standard trials released at the American Diabetes Association’s annual meeting looked at how doses of oral semaglutide as high as 25 milligrams and 50 milligrams worked to reduce weight and improve blood sugar and other health markers.
A 16-month study of about 1,600 people who were overweight or obese and already being treated for Type 2 diabetes found the high-dose daily pills lowered blood sugar significantly better than the standard dose of Rybelsus. From a baseline weight of 212 pounds, the higher doses also resulted in weight loss of between 15 and 20 pounds, compared to about 10 pounds on the lower dose.
Another 16-month study of more than 660 adults who had obesity or were overweight with at least one related disease — but not diabetes — found the 50-milligram daily pill helped people lose an average of about 15% of their body weight, or about 35 pounds, versus about 6 pounds with a dummy pill, or placebo.
This is “notably consistent” with weight loss induced by weekly injections of Wegovy’s highest dose, according to the authors of the study.
There were also side effects. About 80% of participants receiving any size dose of oral semaglutide experienced things like mild to moderate intestinal problems, such as nausea, constipation and diarrhea.
In the 50-milligram obesity trial, there was evidence of higher rates of benign tumors in people who took the drug versus a placebo. In addition, about 13% of those who took the drug had “altered skin sensation” such as tingling or extra sensitivity.
Medical experts predict the pills will be popular, especially among people who want to lose weight but are fearful of needles. Plus, tablets would be more portable than injection pens and they don’t have to be stored in the refrigerator.
But pills may not be a more convenient option for those who already take injectable forms of the drug, such as Ozempic and Wegovy. This is according to Dr. Fatima Stanford, an expert in obesity medicine at Massachusetts General Hospital.
“I don’t find significant hesitancy surrounding receiving an injection,” she said. “A lot of people like the ease of taking a medication once a week.”
In addition, she said, some patients may actually prefer shots to the new pills, which have to be taken 30 minutes before eating or drinking in the morning.
Paul Morer, 56, who works for a New Jersey hospital system, lost 85 pounds using Wegovy and hopes to lose 30 more. Even if pills became available, he said that he’d probably continue with weekly injections.
“I do it on Saturday morning. “It’s part my routine”, he explained. “I don’t even feel the needle. It’s a non-issue.”
Some critics also worry that a pill will also put pressure on people who are obese to use it, fueling social stigma against people who can’t — or don’t want to — lose weight, said Tigress Osborn, chair of the National Association to Advance Fat Acceptance.
“There’s no way to escape the idea that you should be changing your body, said Osborn.
Although Novo Nordisk still hopes to capitalize on the success of an increased-dose tablet that treats both obesity and diabetes, it is also betting heavily on its popularity. Sales of Rybelsus reached about $1. 63 billion last year, more than double the 2021 figure.
Other drug companies are developing oral versions that will work just as well as Eli Lilly and Co.’s Mounjaro – an injectable diabetic medication expected to soon be approved as a weight loss . Lilly researchers reported promising mid-stage trial results for an oral pill called orforglipron to treat patients who are obese or overweight with and without diabetes.
Pfizer, too, has released mid-stage results for dangulgipron, an oral drug for diabetes taken twice daily with food.
Novo Nordisk officials said it’s 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 to demand. Despite surging popularity, injectable doses of Wegovy will be in short supply until at least September, company officials said.
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