(CNN) — Jared Holtz had been considering taking one of the new GLP-1 drugs to lose weight for months before he actually received his prescription, and even after he received it, he waited a month before taking it.
One reason he’s hesitant is that he dislikes injections, and all of the drugs in this class approved for weight loss require users to inject themselves once a week.
“It’s been really hard,” said Holtz, 44, about a week into treatment.
But the need for needles may soon change: At least 12 similar experimental weight-loss drugs designed to be taken as a pill are undergoing clinical trials, with the most advanced one currently in the third and final stage of testing.
These “could dramatically change the weight management landscape in several ways,” he said. Dr. Jody Dachey He is an assistant professor of medicine at Harvard Medical School and an attending endocrinologist at Beth Israel Deaconess Medical Center, and he prescribes weight-loss drugs.
This is an area where a revolution is already happening. Millions The number of people across the U.S. currently using semaglutide and tirzepatide, sold as weight-loss drugs as Wegovy and Zepbound (and better known as diabetes drugs as Ozempic and Mounjaro), is 40.
Dachey said he hopes that a tablet version of the GLP-1 drug might ease symptoms. Shortagelower cost and greater convenience. But she and other doctors also warn about the dangers of abuse — a problem that can be even more prevalent with a daily pill instead of a weekly injection. It can be easier to take more than the recommended amount or to share medication inappropriately.
“There’s a lot to learn about the oral version,” Dachey said.
Semaglutide in tablets
The most advanced of these pills contains a form of semaglutide, the active ingredient in Novo Nordisk’s developmental drugs Ozempic and Wegovy. Reported Last year, a late-stage study in people without diabetes announced that taking the drug daily led to an average of 15% weight loss over 68 weeks, results similar to those seen in the Wegovy trial.
But Novo Nordisk declined to say whether it has applied for approval of the drug from the U.S. Food and Drug Administration. sale The safety profile of oral semaglutide, approved as Rybelsus for the treatment of type 2 diabetes, is far inferior to that of the injectable form, Ozempic.
Although a pill, Rybelsus does come with some challenges. photograph Avoid eating, drinking or taking other medicines for at least 30 minutes every day on an empty stomach. Doctors say it is not as effective as injections and has side effects.
And the dose of oral semaglutide for obesity is much higher, which could make the side effects even more pronounced, he said. Dr. Jorge MorenoHe is an obesity specialist and assistant professor of medicine at the Yale University School of Medicine. The dosage for weight loss is 25-50 milligrams per day, compared with 14 milligrams for Rybelsus and up to 2.4 milligrams per week for Wegovy injections.
“I am more important [gastrointestinal] “Oral semaglutide has fewer side effects than the injectable form,” Moreno said. “I wonder what difference in side effects there might be if oral semaglutide was used in higher doses than the injectable form.” [the] “Injectable dose”
Novo Nordisk said the “majority” of side effects from oral semaglutide in the study were “mild to moderate and diminished over time.” Pharmaceuticals Side effects include nausea, vomiting, and abdominal pain, although not all patients experience these side effects.
Oral GLP-1 competition
Following on from oral semaglutide comes a group of drugs led by Eli Lilly’s orforgliplon, an oral medication that targets GLP-1, a hormone involved in insulin regulation, appetite and digestion.
Lily, which also manufactures the Zepbound and Maunjaro, Reported Last year, a mid-stage trial was announced that people who took orforgliplon for 36 weeks lost an average of 15% of their body weight, a rate comparable to that seen with oral semaglutide but in a shorter time frame. Results from the late-stage trial are expected early next year, says Evan Sagerman, a research analyst at financial firm BMO Capital Markets.
Pharmaceutical companies such as Pfizer and Roche, Structure Therapeutics, Turns Pharmaceuticals and Viking TherapeuticsOral weight-loss drugs are also in the early stages of development, according to BMO’s research.
Beyond semaglutide, Novo Nordisk has several programs in early stages of development to bring the next generation of weight-loss drugs to market.
Earlier this month, data Study results presented at the European Association for the Study of Diabetes showed that subjects given high doses of the experimental drug amicretin lost an average of 13 percent of their body weight over a 12-week period. target Both GLP-1 and another hormone, amylin.
Novo Nordisk also Agreed Last year, it spent up to $1.1 billion to buy Inversago Pharma, gaining access to an experimental oral drug called Monlunabant. Cannabinoids A key receptor for appetite regulation. BMO Research says interim study results for the drug are expected later this year.
“Maintenance Dosing”
Not all of these experimental drugs will necessarily make it to the market, but when they do, one of their main roles will be as “long-term maintenance” treatments for people who have lost enough weight with the injectables, Dachey said.
Dachey says these drugs could be “a good alternative to weekly injections. They may not maximize weight loss as much as early-stage treatment, but they may be better at maintaining weight loss, which is a different, and perhaps much more important, goal for sustaining health benefits.”
Holtz, who watches the weight-loss drug race as a health-care strategist for an investment firm, said he would switch from taking a weekly injection to an oral medication, if one were available, to help him keep the weight off.
Holtz said he lost more than 10 percent of his body weight in three months and is enthusiastic that GLP-1 drugs not only help with weight loss, but also have vascular protection benefits. heart Other potential health benefits advantage.
He said the weekly injections he worried about were nearly painless — something drug makers have worked hard to achieve with auto-injector pens — and he wishes he’d started sooner.
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