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This could really move the needle in the GLP-1 weight loss market.
Semaglutide, the active ingredient in Ozempic and Wegovy, is injected into the fatty tissue just under the skin of the stomach, thigh or upper arm to treat obesity or Type 2 diabetes.
Soon, there may be a promising alternative for the needle-averse, as results of a recent Phase 3 trial confirmed that a daily 25-milligram semaglutide pill can trigger significant weight loss.
“We all knew this was coming, and we all feel that it could potentially be a game changer in terms of adopting these GLP-1s across the board,” Dr. Armando Castro-Tié — senior vice president and physician executive of Northwell Health’s Eastern Region, who was not involved in this research — told The Post.
In the study, overweight or obese participants across four countries were given either a semaglutide pill or a placebo alongside diet and exercise counseling.
GLP-1 drugs like semaglutide mimic a hormone the body naturally produces after eating, making users feel fuller for longer.
The 205 participants who took the daily semaglutide pill lost an average of 13.6% of their body weight over 64 weeks, compared to 102 placebo participants who shed 2.2%.
The authors of the research — funded by Ozempic and Wegovy makers Novo Nordisk — noted that injectable semaglutide, while effective, is a hard sell to people scared of needles.
Plus, the need for refrigeration limits where and to whom the drug can be delivered.
A pill all but eliminates these barriers, and according to Castro-Tié, an oral dose is easier to produce en masse and less likely to fall prey to shortages.
“In terms of the availability, with injectable agents, we ran into supply chain issues and shortages at several times over the past couple of years,” he explained.
“I would imagine that manufacturers would anticipate the demand and ramp up production accordingly,” he added. “But there’s no question that access is going to be magnified multiple times over just because of the ease of use of this oral form.”
The semaglutide pill did cause side effects in 74% of participants, namely gastrointestinal issues, compared to 42.2% of the placebo group.
Castro-Tié said that these side effects are consistent with injectable forms of semaglutide, but they may develop more slowly and last longer.
“The side effect profile was pretty similar compared to the injectable forms, gastrointestinal stuff — nausea, some dyspepsia (indigestion),” Castro-Tié said.
“However, the injectable form is bioavailable a little bit quicker,” he continued. “And so sometimes the patients would have those side effects a little bit sooner, and they would dissipate more quickly than with the oral form.”
The findings were published last week in The New England Journal of Medicine.
Novo Nordisk is seeking regulatory approval for this pill to treat obesity. A decision by the US Food and Drug Administration is expected by the end of the year.
If approved, the oral tablets could be made available sometime in 2026.
Novo Nordisk’s Rybelsus — a pill made with semaglutide — has already been approved for treating Type 2 diabetes in adults.
It’s not the only GLP-1 pill in the works. Eli Lilly’s orforglipron — which mimics GLP-1 — has completed late-stage clinical trials and is nearing market for obesity and Type 2 diabetes management.
