What if treating obesity was as simple as taking an effective pill?
It’s a notion that has long fueled hope among many of the more than 40% of Americans who are considered obese — and draws criticism from those working for broader weight acceptance. The pill could soon be a reality.
High-dose oral versions of the drug in weight-loss drug Wegovy may work just as well as the popular injections when it comes to losing weight and improving health, according to final results from two studies released Sunday night. The powerful pills also appear to work in people with diabetes who are known to have trouble losing weight.
Drug maker Novo Nordisk plans to apply to the US Food and Drug Administration for approval of the pills later this year.
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“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 with the new research.
This presupposes, said Bessesen, that both ways of taking the medication are equally effective, available and affordable. “Those are the most important factors for people,” he said.
While there are other weight loss pills on the market, none achieve the significant reductions seen with injectable drugs like Wegovy. People with obesity will be “thrilled” to have an oral option that’s just 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 already sells Rybelsus, which is approved to treat diabetes and is an oral version of semaglutide, the same drug used in diabetes drugs Ozempic and Wegovy. There are doses up to 14 milligrams.
But the results of two gold-standard studies published at the American Diabetes Association’s annual meeting looked at how doses of oral semaglutide of up to 25 milligrams and 50 milligrams led to weight loss and improvements in blood sugar and other health markers.
How much weight loss?
A 16-month study of about 1,600 people who were overweight or obese and already being treated for type 2 diabetes found that the high-dose daily pills lowered blood sugar significantly better than the standard dose of Rybelsus. From a starting weight of 212 pounds, the higher doses also resulted in a weight loss of 15 to 20 pounds, compared to about 10 pounds with the lower dose.
Another 16-month study of more than 660 adults who were obese or overweight and had at least one related condition — but not diabetes — found that the 50-milligram-a-day pill helped people, an average of about 15% lose 35 pounds of their body weight, compared to about 6 pounds with a dummy pill or placebo.
This is “remarkably consistent” with the weight loss driven by weekly injections of the highest Wegovy dose, the study authors said.
But there were side effects. About 80% of the participants who received any dose of oral semaglutide experienced mild to moderate intestinal problems such as nausea, constipation, and diarrhea.
In the 50-milligram obesity study, there was evidence of a higher rate of benign tumors in people taking the drug compared to people taking a placebo. In addition, about 13% of those taking the drug experienced an “altered skin sensation” such as tingling or hypersensitivity.
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Medical experts believe the pills will be popular with people who want to lose weight but are afraid of needles. Also, tablets would be more portable than injection pens and would not need to be kept in the refrigerator.
But the pills aren’t necessarily a better option for the hundreds of thousands of people already taking injectable versions like Ozempic or Wegovy, said Dr. Fatima Cody Stanford, obesity medicine specialist at Massachusetts General Hospital.
Weight “I don’t feel much reluctance to have an injection,” she said. “Many people appreciate the simple fact that they take a medication once a week.”
In addition, she said, some patients may prefer shots to the new pills, which must be taken 30 minutes before eating or drinking in the morning.
“Part of my routine”
Paul Morer, 56, who works for a New Jersey hospital system, has lost 85 pounds with Wegovy and hopes to lose another 30 pounds. He said he would probably stick with the weekly injections even if pills were available.
“I’ll do it on Saturday morning. It’s part of my routine,” he said. “I can’t even feel the needle. This is not a problem.”
Some critics also worry that a pill would also put pressure on overweight people to take it, fueling social stigma for people who can’t or don’t want to lose weight, said Tigress Osborn, chair of the National Association Promote Fat Acceptance.
“There’s no escaping the narrative that your body is doing badly and it should change,” Osborn said.
Still, Novo Nordisk is banking on the popularity of a higher-dose pill to treat diabetes and obesity. Rybelsus revenue reached about $1.63 billion last year, more than double the 2021 figure.
Other companies are working on oral versions of drugs that work the same way as Eli Lilly and Co.’s Mounjaro — an injectable diabetes drug that’s expected to soon be approved for weight loss. Lilly researchers reported promising mid-stage study results of an oral pill called Orforglipron to treat obese or overweight patients with and without diabetes.
Pfizer has also released mid-term results for dangulgiprone, an oral antidiabetic drug that is taken twice a day with food.
Novo Nordisk officials said it’s too early to say what the cost of the company’s high-dose oral pills would be or how the company plans to ensure sufficient production capacity to meet demand. Despite rising popularity, injectable doses of Wegovy will be in short supply through at least September, company officials said.