The findings of a new clinical trial released Wednesday may point the way to an elusive goal: a safe and effective drug that helps reduce obesity in people.
The study found that obese people receiving a treatment currently used for type 2 diabetes lost significantly more weight than a control group, with a third losing 20% or more of their body weight. Those in the experimental group also experienced greater improvements in other health markers. However, the long-term effects on the health of the treatment are not yet known, which means that we do not yet know its effectiveness or safety as a treatment for obesity.
The drug is called semaglutide and has been so approved in the US since 2017 to help people with type 2 diabetes. Semaglutide helps increase the body’s production of insulin, the hormone that plays an important role in controlling blood sugar (people with type 2 diabetes they stop producing enough insulin or stop responding to it normally, which causes the unstable blood sugar levels that characterize diabetes). It does this by mimicking the human glucagon-like peptide-1 hormone, also called GLP-1.
GLP-1 is a lever in the body system that regulates the sensation of hunger and metabolism. After eating, it is usually released in the gut at levels high enough to curb our appetite. It is likely that one of the frequently reported side effects of semaglutide in patients with diabetes has been reduced appetite and weight loss. And because obesity, a common risk factor for type 2 diabetes it often leads to a dysfunctional metabolism, which is also why some scientists have hoped that the drug can be re-equipped in a genuine treatment for obesity.
This new phase III trial (called STEP-1) was funded by Novo Nordisk – the manufacturers of semaglutide – and involved nearly 2,000 patients over the age of 18 recruited in 16 countries from June to November 2018. All volunteers had reported that they were trying to lose weight unsuccessfully at least once and with a body mass index greater than 30—the limit of obesity—or a BMI of 27 along with health complications probably related to your weight, but not including diabetes. (It should be noted that the BMI has been criticized as too inaccurate to be a reliable marker of health). The findings were published Wednesday in the New England Journal of Medicine.
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All volunteers were encouraged to take a low-calorie diet and exercise more. All of them also received individualized advice from dietitians once a month, either in person or by phone. But about half were randomized to receive a weekly dose of injected semaglutide, while the other received a placebo vaccine. Each dose of semaglutide was 2.4 milligrams, higher than the 1 milligram dose used to treat diabetes.
At the end of the 68-week trial (which almost all participants completed), the results were clear. Those in semaglutide experienced an average weight loss of 33 pounds, while the placebo group experienced an average loss of six pounds. Two-thirds of the treatment group lost at least 10% of their initial weight, while one-third lost at least 20%. They also saw substantial improvements in waist circumstances, blood pressure, and self-reported quality of life.
Accordingly, the conclusions are nothing short of huge, given the relative lack of options for people who want to treat their obesity with pharmaceuticals. (There are several drugs currently approved in the United States for obesity, but none have demonstrated the degree of success seen here).
“The findings of this study represent a major breakthrough in improving the health of people with obesity,” said Rachel Batterham, an obesity researcher at University College London in the UK who helped lead one of the arms of the trial. . statement released by the university. “No other drug has come close to producing this level of weight loss; really, that’s a game changer. For the first time, people can achieve through medication what was only possible through weight loss surgery.”
Despite promising news, at least some external experts are more cautious about the implications of the study. In an accompaniment editorial, Julie Ingelfinger and Clifford Rosen, both doctors and NEJM editors, described the results as a “good start”.
In the trial, semaglutide was generally well tolerated, even at higher doses, with symptoms such as nausea, diarrhea, and vomiting more common in the treatment group. But Ingelfinger and Posen point out that other research has suggested it could increase the risk of more serious health problems like pancreatitis. In mice, it has been associated with certain thyroid tumors when taken as a pill, which is why the drug is currently not recommended for people with multiple endocrine neoplasia type 1, an inherited condition that increases the risk of thyroid cancer.
They also observe that obesity is a chronic condition. And, despite the 68-week trial duration, we still don’t know how effective, safe, or practical it would be for someone to take a long-term weekly dose of injected semaglutide. These potential risks and limitations do not mean that the drug cannot be used for obesity, but scientists will need to continue to assess whether its benefits outweigh its harms if it obtains regulatory approval. Some health experts and activists have done the same questioned the value of treating obesity in general, arguing that doctors should strive to improve people’s health to any size, recognizing that weight loss may not be the optimal goal for some.
“In short, we have a long way to go to control the obesity epidemic, but STEP 1 serves its name well,” they wrote.
Health regulatory agencies such as the Food and Drug Administration will soon have to weigh these issues, as Novo Nordisk already plans to introduce the drug for approval as a treatment for obesity in Europe, the United Kingdom and the United States. .