Demand for drugs like Ozempic and Wegovy is soaring due to their weight-loss benefits, and now drug companies are developing new versions of pills that could make them even more popular.
Currently, these drugs need to be injected into the thigh, waist, or upper arm once a week. Pills or tablets may be easier to take and more convenient for many patients. “Having another route of administration would be a huge advantage,” says Michael Weintraub, an endocrinologist and assistant professor of medicine at NYU Langone Health. Many people are afraid of needles and others may not want to be seen injecting a drug.
Last week, Novo Nordisk, which makes semaglutide under the brand names Ozempic and Wegovy, announced positive clinical trial results for a tablet form of the drug. In a study of 667 overweight or obese adults, participants lost an average of 15.1% of their body weight over 17 months while taking the daily tablet, compared to people who lost 2.4% while taking of a placebo pill. The results were comparable to a previous trial of weekly injections of Wegovy, in which people lost nearly 15 percent of their weight in the same time period.
“The choice between a daily tablet or a weekly injection for obesity has the potential to offer patients and healthcare professionals the opportunity to choose what best suits individual treatment preferences,” said Martin Holst Lange, vice president development executive for Novo Nordisk, in a company statement. The company plans to seek approval in the US and Europe for its tablet later this year.
Semaglutide was initially developed for the treatment of type 2 diabetes. It mimics a hormone called GLP-1, which regulates insulin. But scientists found that it also led to weight loss in both laboratory animals and people. That’s because GLP-1 also signals the brain when the stomach is full, so people taking these drugs have fewer cravings and a reduced appetite. Today, Ozempic is approved in the United States and other countries for the treatment of type 2 diabetes, while Wegovy is specifically indicated for chronic weight management.
Novo Nordisk already makes a pill version of semaglutide, but it hasn’t shown the same weight loss benefits as Ozempic and Wegovy. Called Rybelsus, it was approved in 2019 by the U.S. Food and Drug Administration for type 2 diabetes. That pill is just 14 milligrams, while the tablet the company is currently testing is 50 milligrams.
In the current study, the researchers found that the new tablet was safe but that some patients experienced gastrointestinal side effects, most of which were mild to moderate and decreased over time, according to the company’s statement. The statement said the side effects were similar to those experienced by patients on Ozempic and Wegovy. These drugs can cause nausea, vomiting, bloating, constipation, and diarrhea. Often these occur in the initial stages of taking the drug, when the dose is steadily increased, but decrease after several weeks.
“People can also get quite dehydrated on these drugs, because not only do you forget to eat but you forget to drink,” says Kunal Shah, assistant professor of endocrinology at Rutgers University who specializes in treating obesity, referring to Ozempic and Wegovy . .
Shah says a new pill with a higher dosage could potentially cause more frequent or severe cases of these side effects. “That’s more than three times what we typically give for oral semaglutide,” he says of the dosage for the experimental tablet. And because the current study compares the high-dose pill to a placebo, it’s unclear how the new pill’s side-effect profile will stack up against the injectable version.
Novo Nordisk spokeswoman Allison Scheider declined to provide details about the risk of side effects, saying those details would be presented later in June at a meeting of the American Diabetes Association.
Pfizer is also racing to create a diet pill. Last week the company published positive results for its investigational drug danuglipron, a different molecule that also mimics the hormone GLP-1.
In a study of 411 adults with type 2 diabetes that tested different doses of the pill, participants taking a high dose lost an average of about 10 pounds over four months, compared with those given a placebo. The most common side effects were nausea, diarrhea and vomiting. Most were mild in nature, but 57 participants did not continue the study due to these side effects. As with other GLP-1 drugs, these side effects were most present at the beginning of the treatment cycle and diminished over time, Pfizer spokeswoman Jerica Pitts told WIRED by email. “Adequate counseling before the first dose can help patients continue taking their medications through these initial bumps,” Pitts wrote.
A pill version of these diet drugs might come with strict instructions on how to take them. The existing semaglutide pill, Rybelsus, should be taken at least half an hour before any food, drink or other oral medicine in the morning and can only be taken with a small amount of water. “Without meeting these strict criteria, uptake will be hampered,” Weintraub says.
Pfizer’s pill may have an edge in this regard, Weintraub says, because its absorption isn’t affected by food, so patients could take it with a meal. However, Pfizer’s danuglipron should be taken twice a day, once in the morning and once in the evening. Pfizer has another diabetes pill in development, lotiglipron, designed to be taken once a day. Both are in Phase 2 clinical trials, and Pitts said the company will make a decision later this year on which to move to late-stage testing.
Semaglutide’s bioavailability—how much of the drug reaches its destination—was a challenge when it was formulated into a pill, says Amy Rothberg, a physician and clinical professor at the University of Michigan Health who specializes in weight management and in the treatment of diabetes. Injecting semaglutide is a more efficient way to get it into the bloodstream, she says, which is why Ozempic and Wegovy injectors use only a small amount of the drug. But swallowing it in pill form means it has to pass through the digestive tract, where it’s largely absorbed.
He thinks most of his patients would prefer a pill over the current injectable version. “That said, people always forget their medications. Patients should commit to taking something every day,” Rothberg says. After stopping Ozempic and Wegovy, appetite increases again, and many people who stop these drugs regain weight.
As for the cost of the new diet pills, Shah says they’ll likely be as expensive as the injectable versions, at least initially. “Every time a new drug or a new version of a drug hits the market, the chances that insurance will cover it right away is pretty slim,” he says. While most insurers cover these diabetes drugs, they aren’t always covered just for weight loss, and Ozempic and Wegovy cost about $900 and $1,300 a month, respectively, without insurance, according to Novo Nordisk list prices.
In an email, Novo Nordisk spokesman Scheider said it was too early to speculate on the price of a pill version. “It is too early for us to comment on a price at this time,” Pitts also wrote of Pfizer’s pills in development.
#pill #version #Ozempic #coming