Ozempic and Wegovy — both injectable forms of semaglutide — have become synonymous with weight loss in recent months and years. Now a new drug is on the horizon that would offer the same medication in an oral (pill) format.
Created by Novo Nordisk, the same company that makes Ozempic and Wegovy, the new drug just completed its Phase 3 clinical trials. The results were announced on Sunday at the American Diabetes Association (ADA) Scientific Session in Los Angeles, California.
The oral medication, which is indicated for type 2 diabetes or weight loss for patients with obesity, would provide an alternative to people who are not open to getting injections.
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“The opportunity to have a tablet that can offer the effectiveness of weight loss for people with diabetes is really exciting,” Dr. Robert Gabbay, Boston-based chief scientific and medical officer for the ADA, told Fox News Digital during a phone interview from the scientific session.
“It opens up this type of therapy to many more people that could potentially benefit.”
A new drug that will offer the same medication in an oral (pill) format that current injectables offer just completed its Phase 3 clinical trials. (iStock)
Ozempic is marketed for people with type 2 diabetes, while Wegovy is indicated for weight loss. Both medications are semaglutides, just with different dosages.
“Our focus has been primarily on people with diabetes, but it turns out that the vast majority of people with type 2 diabetes also have obesity,” Gabbay explained.
“So having a medication that can address a central issue for people with diabetes is really important — especially for those who are somewhat resistant to or concerned about doing an injection.”
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The double-blind, randomized, Phase 3 trial followed 667 people who were randomly assigned to either 50 milligrams of the drug or a placebo, explained the lead study author, Dr. Filip Knop, professor at Gentofte Hospital at the University of Copenhagen.
The participants took the semaglutide once daily for a 68-week period and were monitored for both safety and effectiveness.
Ozempic is marketed for people with type 2 diabetes, while Wegovy is indicated for weight loss. Both medications, however, are semaglutides, just with different dosages. (Getty Images)
“It’s important to emphasize that the participants were people who had obesity but did not have type 2 diabetes,” Knop told Fox News Digital in a phone interview.
“They could have [had] pre-diabetes, but they were not allowed to be enrolled in the trial if they had type 2 diabetes.”
The average amount lost by the patients was 44 pounds.
For the 86% of participants who remained on the drug throughout the trial, they achieved an average body weight loss of 17.4% compared to just 1.8% for those on the placebo, explained Knop, who has been involved in diabetes and metabolic research since 1999.
The average amount lost by the patients was 44 pounds.
In addition to helping with weight loss, the semaglutide medication can also help to reduce cardiovascular disease in people with diabetes, Gabbay noted.
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“For those people who are at high risk or [who] already have cardiovascular disease, the parent drug has been shown to reduce mortality, and there’s no reason to expect that this wouldn’t be the case with the oral version,” he told Fox News Digital.
Common side effects during the trial were gastrointestinal in nature — such as nausea, vomiting, constipation and diarrhea — similar to what has been reported for Ozempic and Wegovy.
The new oral medication, which is indicated for type 2 diabetes or weight loss for patients with obesity, would provide an alternative to people who are not open to getting injections. Patients would take a daily pill. (iStock)
Some less common side effects reported during the first 20 weeks of the trial were short-term changes in skin sensation, such as hypersensitivity or paraesthesia (tingling or prickling), Knop said.
Following the successful results of the Phase 3 trial, the drugmakers will look to start the process of applying for FDA approval.
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“We’re pleased to see that there are new options for people with diabetes and obesity,” Gabbay said.
“Having something that is orally available should increase the number of people who can benefit from these kinds of treatments.”
