Feb. 11, 2021 -- A diabetes drug called semaglutide helped people who are overweight or obese lose an average of 15% of their body weight over 16 months, according to a new study published Wednesday in TheNew England Journal of Medicine.
The once-a-week shot works by increasing the production of insulin and appears to also suppress appetite. It’s under review by the FDA as a chronic weight management drug. If approved, it would be the fifth prescription weight loss drug on the U.S. market.
“This is by far the most effective intervention we have seen for weight management when you compare it to many of the currently existing drugs,” Robert Kushner, MD, one of the study authors and an internal medicine doctor at Northwestern Medicine, said in a statement.
The research team tested how safe and effective it was to have a weekly shot of 2.4 milligrams of semaglutide, along with individual counseling on diet and exercise. Among 1,960 people who were either overweight or obese, two-thirds received the drug and coaching sessions, and a third received a placebo drug and coaching sessions. The study took place between the fall of 2019 and spring of 2020 at 129 locations in 16 countries.
The average baseline weight was 230 pounds, and the average body mass index was 38. Overall, people in the study group lost about 15% of their body weight in 68 weeks, as compared with a 2.4% loss in the placebo group. On average, people who took the drug lost about 33 pounds, and those in the placebo group lost 5 pounds.
About 70% of the study participants reached a loss of 10% or more of their body weight, which is considered clinically relevant, Kushner said. Other chronic weight management drugs on the market have helped people to lose 6% to 11% of their body weight, so semaglutide could be nearly twice as effective, he said.
“A lot of the health concerns we see in people who are struggling with their weight, such as diabetes, high blood pressure, or gastroesophageal reflux disease (GERD), tend to improve when they reach a weight loss of 10%,” he said.
About one-third of the participants lost 20% of their baseline weight, or about 46 pounds. This is similar to the weight loss for patients who have bariatric surgery, Kushner said.
“It’s the very first time we have a medication that even begins to approach the weight loss people achieve with bariatric surgery,” he said.
Those who took the drug were more likely to experience nausea, diarrhea, vomiting, or constipation. About three-quarters of the study group had these side effects, as compared to less than half of those who took the placebo. After the study, participants reported better physical functioning, less pain, better blood pressure, and better glucose control.
Semaglutide is now on the market to manage diabetes, and it is approved for use at a lower dose than used in this study. The drugmaker, Novo Nordisk, filed for FDA approval in December for the 2.4-milligram dose to be used for weight management. Based on the standard FDA timeline, the review could take about 6 months, the company said.
More than 42% of Americans are obese, according to the CDC, which means they have a body mass index of 30 or more. Obesity raises the risks for cancer, type 2 diabetes, heart disease, and stroke. But there are few treatments, and current drugs require shots once, twice, or three times per day.
The semaglutide study is “another first step,” Julie Ingelfinger, MD, a nephrologist at Massachusetts General Hospital, and Clifford Rosen, MD, a researcher at the Tufts University School of Medicine, wrote in an accompanying commentary in TheNew England Journal of Medicine.
But they noted several limitations. For instance, most of the participants were white, which doesn’t reflect the U.S. population. In addition, the trial didn’t investigate the long-term efficacy of sustained weight loss. Current drugs on the market often don’t perform well in the real world, and some have been pulled due to side effects.
“In sum, we have a long way to go to control the obesity epidemic,” they wrote.