Diabetes drug dramatically improves treatment for obesity in large clinical trial

The results of a new clinical trial released Wednesday may pave the way for an elusive goal: a safe and effective drug that helps reduce obesity in people.

The study found that obese people receiving treatment currently used for type 2 diabetes lost significantly more weight than a control group, with one-third losing 20% ​​or more of their body weight. Those in the experimental group also experienced greater improvements in other markers of health. However, the long-term health effects of the treatment are not yet known, which means we do not yet know how effective or safe it is as a treatment for obesity.

The drug is called semaglutide, and it has been approved in the United States 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 our blood sugar (people with people with type 2 diabetes stop making enough insulin or stop responding to it normally, causing the blood sugar instability that is characteristic of diabetes.). It does this by mimicking the human glucagon-like peptide-1 hormone, also known as GLP-1.

GLP-1 is one of the levers in the body system that regulates our hunger pangs and metabolism. After eating, it is usually released in the intestine at levels high enough to reduce our appetite. This is probably the reason why one of the frequently reported side effects of semaglutide in diabetic patients has been reduced appetite and weight loss. And because obesity, a common risk factor for type 2 diabetes, Often involves dysfunctional metabolism, which is also why some scientists have hoped that the drug could be reorganized into a real treatment for obesity.

This new phase III trial (called STEP-1) was funded by Novo Nordisk – the manufacturer of semaglutide – and involved nearly 2,000 patients over the age of 18 recruited from 16 countries from June to November 2018. The volunteers all had reported trying to lose weight without success at least once and either had a body mass index over 30—the obesity threshold –or a BMI of 27 with health complications likely related to their weight, but not including diabetes. (BMI, it should be noted, was critical too imprecise to be a reliable marker of health). The results were published Wednesday in the New England Journal of Medicine.

All volunteers were encouraged to follow a calorie-reduced diet and exercise more. They also all received personalized advice from dietitians once a month, in person or by phone. But about half were randomized to receive a weekly injected dose of semaglutide, while the other received a placebo injection. Each dose of semaglutide was 2.4 milligrams, higher than the 1 milligram dose used for the treatment of diabetes.

At the end of the 68-week trial (which almost all of the participants completed), the results were clear. People on 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 basal weight, while a third lost at least 20%. They also found more substantial improvements in height circumstance, blood pressure, and self-reported quality of life.

At first glance, the results are simply stunning, given the relative lack of options. for people looking to fight their obesity with pharmaceuticals. (There are several drugs currently approved in the United States for obesity, but none have shown the degree of success seen here.)

“The results of this study represent a major breakthrough in improving the health of obese people,” said Rachel Batterham, obesity researcher at University College London in the UK who helped lead one arm of the trial. , in one declaration published by the university. “No other drug has come close to producing this level of weight loss – it really is a game changer. For the first time, people can achieve through drugs what was only possible through surgery. of weight loss.

Despite the promising news, at least some outside experts are more cautious about the implications of the study. In an accompaniment editorial, Julie Ingelfinger and Clifford Rosen – both doctors and NEJM editors – called the results “a good start”.

In the trial, semaglutide was overall well tolerated, even at a higher dose, 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 may 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 type 1 multiple endocrine neoplasia, an inherited disease that increases the risk of thyroid cancer.

They also note that obesity is a chronic disease. And despite the trial’s duration of 68 weeks, we still don’t know how effective, safe, or convenient it would be for someone to take an injected weekly dose of semaglutide over the long term. These potential risks and limitations don’t mean the drug can’t be used for obesity, but it does mean that scientists will need to continue to assess whether its benefits outweigh its harms if it gets regulatory approval. Some health experts and activists have also interrogates the value of treating obesity in general, arguing that doctors should strive to improve the health of people of all sizes, while recognizing that weight loss may not be the goal optimal for some.

“In summary, we have a long way to go in controlling the obesity epidemic, but the first step is aptly named,” they wrote.

Health regulatory agencies like the Food and Drug Administration will soon have to weigh these issues themselves, as Novo Nordisk already plans to submit the drug for approval as a treatment for obesity in Europe, the UK and the United States. United States.