According to a new study published in the New England Journal of Medicine on Wednesday, a diabetes drug called semaglutide helped overweight or obese people lose an average of 15% of their weight in 16 months. The weekly injection works by increasing insulin production and also seems to suppress appetite.
It is being reviewed by the FDA as a chronic weight management drug. If approved, it will become the fifth prescription weight loss drug on the US market. One of the study authors, Northwestern Medical physician Robert Kushner, said in a report: "When you compare it with many existing drugs, this is what we have done so far in weight management. The most effective interventions I have seen." Statement.The research team tested the safety and effectiveness of weekly injections of 2.4 mg of semaglutide and individual diet and exercise counseling. Of the 1,960 overweight or obese people, two-thirds received medication and counseling courses, and one-third received placebo medications and counseling courses. The study was conducted in 129 locations in 16 countries/regions from the fall of 2019 to the spring of 2020.
The average baseline weight is 230 pounds and the average body mass index is 38. Overall, people in the study group lost about 15% of their body weight in 68 weeks, while the placebo group lost 2.4%. On average, people who took the drug lost about 33 pounds, and people in the placebo group lost 5 pounds.
Kushner said that approximately 70% of study participants lost 10% or more of their weight, which is considered clinically significant. He said that other chronic weight management drugs on the market have helped people lose 6% to 11% of their body weight, so semaglutide is almost twice as effective.
"Many of the health problems we see in people who struggle with weight, such as diabetes, high blood pressure or gastroesophageal reflux disease (GERD), tend to improve when they lose 10% of their weight," he said.
About one-third of the participants lost 20% of their baseline weight, or about 46 pounds. Kushner said this is similar to the weight loss of patients undergoing bariatric surgery. "This is the first time we have a drug that has even begun to approach the weight loss that people can achieve through bariatric surgery," he said.
People who take this drug are more likely to experience nausea, diarrhea, vomiting or constipation. Approximately three-quarters of the study group had these side effects, compared with less than half of those taking a placebo.
After the study, participants reported better physical function, less pain, better blood pressure, and better blood sugar control.
Semaglutide is now on the market for the treatment of diabetes, and it is approved to be used in a lower dose than the dose used in this study.
The drug maker Novo Nordisk applied to the FDA for approval of the 2.4 mg dose for weight management in December. The company stated that according to the FDA's standard timetable, the review may take about 6 months.
According to the CDC, more than 42% of Americans are obese, which means their body mass index is 30 or higher. Obesity increases the risk of cancer, type 2 diabetes, heart disease, and stroke. However, there are few treatments, and current drugs require injections once, twice or three times a day.
The semaglutide study is "another first step," wrote Julie Ingelfinger, MD, a nephrologist at Massachusetts General Hospital and Clifford Rosen, MD, a researcher at Tufts University School of Medicine, in an accompanying commentary in the New England Journal of Medicine.
But they pointed out some limitations. For example, most participants are white, which does not reflect the American population. In addition, the trial did not investigate the long-term effects of sustained weight loss. Drugs currently on the market often perform poorly in the real world, and some drugs have been discontinued due to side effects. They wrote: "In short, we still have a long way to go to control the obesity epidemic."