With the obesity epidemic in America worsening over the years, many biotechnologists have emerged in the hope of developing weight loss medications that would help stem this tide. But now, Novo Nordisk’s semagglutide for dairy cow diabetes is showing results so surprisingly effective in obesity that it may have a head start on the market.
In a study of nearly 2,000 people, participants injected themselves with semagglutide or placebo for 68 weeks. Patients on the drug arm had an average weight loss of 15%, compared with just 2.4% with placebo, and almost a third lost more than 20% of their weight. The researchers published the data Wednesday in the New England Journal of Medicine, and all p values resulted in p <0.001.
Robert KushnerThese results mark a “game changer” in the field of obesity that, so far, has not seen results as effective as these, study leader Robert Kushner told New York Times.
The data also marks an important milestone in relation to diabetes. There are no approved drugs for obesity in the U.S. that also prevent or treat type 2 diabetes. But given that semagglutide is already approved in that indication, the results suggest that Novo could end up killing two birds with one stone only here.
In an exploratory outcome, doctors analyzed patients classified as “pre-diabetes” and observed numerical improvements in glycated hemoglobin levels. Among those in this group, 84.1% in the semaglutide arm saw improvements at these levels, compared with 47.8% in the placebo group. The researchers did not perform a p-value at this endpoint.
Obesity has proven to be a challenging field to treat for years, and not just with drugs. Typical weight control strategies are often not enough to achieve total control, and those who continue with bariatric surgery to change the digestive tract end up regaining weight most of the time.
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 semaglutida.
Some concerns remain about the safety of the drug, for a NEJM editorial published together with the data. Although similar levels of side effects were observed in both groups, 89.7% in the drug arm and 86.4% in the control, there was a higher rate of gastrointestinal events among those who took semagglutide – 74.2% vs. 47.9%.
Most of them fall into mild or moderate categories, but serious gastrointestinal disorders were responsible for the difference in the rates of total serious adverse events, the study authors said. Serious adverse events were reported in 9.8% and 6.4% of semaglutida and placebo participants, respectively, with 1.4% of participants under semaglutida reporting a severe GI event and 0% in the placebo group.
The study population was also not representative of the US population as a whole, with the majority of 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 drug GLP-1 has already made billions for Novo Nordisk, raising $ 1.64 billion in 2019 and $ 1.5 billion in the first half of 2020. In addition to diabetes, the company also received the designation of innovative therapy for semagglutida at NASH, another area filled with speed reductions.