Novo Nordisk's blockbuster diabetes drug blows the doors off in obesity, proving highly effective in driving weight loss
As the obesity epidemic in America worsened throughout the years, many biotechs cropped up hoping to develop weight-loss drugs that would help stem this tide. But now, Novo Nordisk’s diabetes cash cow semaglutide is showing such startlingly effective results in obesity that it may have a head start in cornering the market.
In nearly a 2,000-person trial, participants injected themselves with either semaglutide or placebo for 68 weeks. Patients in the drug arm saw an average 15% weight loss, compared with just 2.4% on placebo, and almost a third lost more than 20% of their weight. Researchers published the data Wednesday in the New England Journal of Medicine, and all p-values came out to p<0.001.
Those results mark a “game-changer” in an obesity field that, to this point, has not seen results as effective as these, study leader Robert Kushner told the New York Times.
The data also mark an important milestone in regards to diabetes. There are no approved obesity medications in the US that also prevent or treat type 2 diabetes. But given that semaglutide is already OK’ed in that indication, the results suggest Novo could end up killing two birds with one stone here.
In an exploratory endpoint, clinicians looked at patients classified as “prediabetes” and saw numerical improvements in glycated hemoglobin levels. Among those in that group, 84.1% in the semaglutide arm saw improvements in these levels, compared with 47.8% in the placebo group. Researchers did not run a p-value in this endpoint.
Obesity has proved a challenging field to treat for years, and not just with drugs. Typical weight management strategies are often not enough to achieve full control, and those who follow with bariatric surgery to alter the digestive tract end up regaining weight more often than not.
That thesis appeared to be confirmed again in this trial, Kushner said, as everyone in the study participated in a diet and exercise program, regardless of whether they received semaglutide.
Some concerns remain over the drug’s safety, per a NEJM editorial published alongside the data. Though similar levels of side effects were seen in both groups, 89.7% in the drug arm and 86.4% in control, there was a higher rate of gastrointestinal events among those taking semaglutide — 74.2% vs. 47.9%.
Most of these fell into the mild or moderate categories, but serious gastrointestinal disorders accounted for the difference in total severe adverse event rates, the study authors said. Serious adverse events were reported in 9.8% and 6.4% of semaglutide and placebo participants, respectively, with 1.4% of participants on semaglutide reporting a severe GI event and 0% in the placebo group.
The trial population also did not prove representative of the US population as a whole, with most participants being women (74.1%) and White (75.1%). Overall, however, the results proved to be a significant step in the right direction, the author wrote.
The GLP-1 drug has already reaped billions for Novo Nordisk, taking in $1.64 billion in 2019 and $1.5 billion in the first half of 2020. In addition to diabetes, the company also has received breakthrough therapy designation for semaglutide in NASH, another area filled with speed bumps.