Fact verified by Nick Blackmer
A daily oral version of the blockbuster weight-loss drug semaglutide appears to be as effective as the weekly injectable sold as Wegovy.
Drugmaker Novo Nordisk shared the data via a press release last week.
Oral semaglutide is already available for the treatment of diabetes under the brand name Rybelsus. The company is seeking a weight-loss indication for a higher-dose version of the same drug.
An oral version of semaglutide, the drug marketed as injectables Ozempic and Wegovy, causes substantial weight loss in people with obesity and overweight, according to data shared by drugmaker Novo Nordisk last week. While it hasn’t exactly been approved yet as an indication for weight loss, a prescription pill or tablet may soon be a viable option for treating obesity.
Novo Nordisk already sells oral semaglutide for the treatment of diabetes under the brand name Rybelsus and is now testing a high-dose version for weight loss.
In a study of nearly 700 overweight or obese adults, patients taking a daily tablet of semaglutide lost 15.1% of their body fat over 17 months, compared with 2.4% among people who were only making changes. to the lifestyle. This puts it on par with Wegovy; the weekly injection caused a 14.9% weight loss over the same period in a previous study.
Oral formulations, such as pills or tablets, could provide more options for patients who are unwilling or unable to self-inject glucose-blocking drugs.
Related: Who Should Get Weight Loss Drugs? Why people with obesity can’t access Ozempic, Mounjaro
Just as with other chronic health conditions, it is exciting to be able to offer a variety of different medical options to patients and enable them to select agents that will work best with their lifestyle, values and preferences, Edmond Wickham III , MD, MPH, an obesity medicine specialist and associate professor of internal medicine and pediatrics at Virginia Commonwealth University, told Verywell.
Novo Nordisk said it expects to file for Food and Drug Administration (FDA) approval of the drug later this year.
Definition of obesity and overweight
For the study, the researchers included participants with the following criteria:
A body mass index (BMI) greater than or equal to 27 kg/m2 with at least one of the following weight-related complications: hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
A BMI greater than or equal to 30 kg/m2
How does a tablet compare to injectables?
Novo Nordisk tested a once-daily semaglutide oral tablet in 667 people with obesity or overweight with at least one comorbidity.
Looking at people who adhered perfectly to the treatment, the researchers saw a 17.4 percent weight loss over 68 weeks compared with a 1.8 percent reduction in the placebo group.
Nearly 90% of those taking oral semaglutide lost 5% more of their weight after 68 weeks, compared with 24.5% in the placebo group. This is slightly more than those taking injectable Wegovy.
The popular weight loss or diabetes drugs Wegovy, Ozempic, Mounjaro, and Rybelsus are all glucagon-like peptide-1 (GLP-1) receptor agonists. Rybelsus, Novo Nordisk’s low-dose semaglutide tablet, was the first drug in its class to be administered orally.
Rybelsus is currently available in strengths of 3, 7, and 14 milligrams (mg) for the treatment of type 2 diabetes. In the latest study, the company tested a 50 mg dose for weight loss.
Related: What is the difference between Ozempic, Wegovy and Mounjaro?
So far, the side effects of a tablet seem similar to the side effects of injections. As with all glucose-lowering medications, oral semaglutide can have gastrointestinal side effects, such as nausea, abdominal pain, and vomiting. Novo Nordisk said patients experienced these adverse events more commonly when their dosage was increased.
The company has not yet shared the full results of the clinical trial data. Because the dosage is more than three times greater than the current highest Rybelsus option, Wickham said it’s possible the weight-loss drug would have more side effects.
Raoul Manalac, MD, obesity medicine specialist and Senior Director of Clinical Experience for Ros Body Program, said he looks forward to reading the full study results to learn more about how high-dose oral semaglutide performs. compare to a high-dose injectable version.
Without a true head-to-head test, the data on the incidence and degree of side effects with high-dose oral semaglutide treatment can at least give us an idea of how patients’ experiences might compare to those using the injectable form. , helping patients and providers choose the best option for each individual, said Manalac.
Related: Generic Mounjaro may soon join Wegovy as an approved weight-loss drug
Opening options for patients
If approved, oral semaglutide could improve weight-loss options for people who prefer not to self-inject the drug.
But oral semaglutide has its limitations. In order for the drug to be absorbed properly, it must be taken on an empty stomach, one hour before taking other medications and half an hour before eating.
If a person takes the drug along with food, only small amounts of the drug will be absorbed and it may lose substantial effectiveness, said Daniel Drucker, MD, FRCPC, an expert in diabetes and obesity treatments and a senior research scientist at the Lunenfeld- Tanenbaum Research Institute in Toronto, Canada.
Some people get up in the morning and can’t get their coffee or breakfast for 45-60 minutes and it fits into their routine, while other people might say, the moment I get up, I’m starving, I need a coffee, and I don’t want to wait 60 minutes, Drucker said. I think more flexibility is always a good thing for people.
Wickham said that in most cases, the choice of taking semaglutide by mouth or by injection will come down to patient preference. He said the injections haven’t proven to be too great a barrier to use and he doesn’t expect oral semaglutide to outperform the injectable versions of the diet drugs if it proves more effective.
In rare cases, patients may experience allergic reactions at the injection site. Wickham said that for most people with skin conditions, such as eczema and psoriasis, patients are usually able to find places to self-inject that don’t cause pain.
I’ve had a handful of patients who had some spot reactions with injectable semaglutide and then switched to Rybelsus and haven’t had any problems with that, Wickham said. They were able to experience some of the drug’s benefits without worrying about the local reaction with the injection.
Manalac said that drug makers have come a long way in creating self-injection pens that can be used quite comfortably. However, there are likely to be many patients who are put off by the idea of injections.
The availability of a highly effective oral semaglutide unlocks the life-changing opportunity in diabetes and weight management for a significant number of people who might not otherwise have pursued it, said Manalac.
What does it mean to you
Some people will prefer an oral version of semaglutide, while others may be able to adhere better to a weekly injection. Talk to a healthcare professional about your lifestyle and which weight loss regimen is right for you.
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