Novo Nordisk’s Successful Diabetes Drug Shatters the Doors to Obesity, Proving Highly Effective Weight Loss Support – Endpoints News

As America’s obesity epidemic worsened over the years, many biotechnologies emerged in hopes of developing weight loss drugs that would help stem this tide. But now Novo Nordisk’s Diabetes Cash Cow Semaglutide is showing such surprisingly effective results in obesity that it may have a head start in grabbing the market.

In a trial of nearly 2,000 people, participants injected either semaglutide or a placebo for 68 weeks. Patients in the medicated arm saw an average weight loss of 15%, compared to just 2.4% on the placebo, and nearly a third lost more than 20% of their weight. The researchers released the data Wednesday in the New England Journal of Medicine, and all p-values ​​output at p <0.001.

These findings mark a “game changer” in an area of ​​obesity that, at this point, has not seen results as effective as these, study leader Robert Kushner told the New York Times.

The data also marks an important milestone in diabetes. There are no approved obesity drugs in the United States that also prevent or treat type 2 diabetes. But since semaglutide is already accepted in this indication, the results suggest that Novo could end up killing people. two birds from one stone here.

In an exploratory endpoint, clinicians looked at patients classified as “prediabetes” and found numerical improvements in glycated hemoglobin levels. Of those in this group, 84.1% in the semaglutide arm saw an improvement in these levels, compared to 47.8% in the placebo group. The researchers did not run a p-value in this endpoint.

Obesity has been a difficult area to treat for years, and not just with medication. Typical weight management strategies are often not enough to achieve full control, and those who have bariatric surgery to change the digestive tract end up gaining weight more often.

This thesis appeared to be confirmed again in this trial, Kushner said, because all study participants participated in a diet and exercise program, whether or not they received semaglutide.

Some concerns remain about the drug’s safety, according to a NEJM editorial published with the data. Although similar levels of side effects were seen in the two groups, 89.7% in the drug arm and 86.4% in the control group, there was a higher rate of gastrointestinal events in patients. people taking semaglutide – 74.2% vs. 47.9%.

Most of them fell into the mild or moderate categories, but severe gastrointestinal disturbances explained the difference in total rates of serious adverse events, the study authors said. Serious adverse events were reported in 9.8% and 6.4% of semaglutide and placebo participants, respectively, 1.4% of participants on semaglutide reporting a severe gastrointestinal event and 0% in the placebo group.

The test population was also not found to be representative of the American population as a whole, with most participants being women (74.1%) and whites (75.1%). Overall, however, the results turned out to be a significant step in the right direction, the author wrote.

The drug GLP-1 has already raised billions of dollars for Novo Nordisk, bringing in $ 1.64 billion in 2019 and $ 1.5 billion in the first half of 2020. In addition to diabetes, the company has also received the designation breakthrough therapy for semaglutide in NASH, another area filled with speed bumps.