The findings of a new clinical trial released Wednesday could point the way to an elusive goal: a safe and effective drug that will help reduce obesity in humans.
The study found that obese people who received 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 markers of health. However, the long-term health effects of the treatment are not yet known, which means that we do not yet know how effective or safe it is as a treatment for obesity.
The drug is called semaglutide, and it is 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 a big role in regulating our blood sugar (people with type 2 diabetes stop making enough insulin or stop responding to it, which causes unstable blood sugar levels characteristic of diabetes.). It does this by mimicking the human glucagon-like peptide-1 hormone, also known as GLP-1.
GLP-1 is a lever of the body system that regulates our hunger and metabolism. After eating, it is usually released into the intestines in a sufficient amount to curb our appetite. This is probably why a commonly reported side effect of semaglutide in patients with diabetes is decreased appetite and weight loss. And because overweight, a common risk factor of type 2 diabetes, is often accompanied by a dysfunctional metabolism, which is why some scientists have hoped that the drug could be transformed into a real obesity treatment.
This new phase III trial (called STEP-1) was funded by Novo Nordisk – the makers of semaglutide – and involved nearly 2,000 patients over the age of 18 who had been recruited in 16 countries from June to November 2018. The volunteers had all reported that they tried to lose weight at least once without success and either had a body mass index greater than 30-the cut-off for obesityor a BMI of 27 along with health complications likely related to their weight, but excluding diabetes. (BMI, it should be noted, is criticized as too imprecise to be a reliable indicator of health). The findings were published Wednesday in the New England Journal of Medicine.
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All volunteers were encouraged to eat a low-calorie diet and to exercise more. They also all received individual counseling from dietitians once a month, either in person or by telephone. Only 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 diabetes treatment.
By the end of the 68-week trial (which nearly all participants completed), the results were clear. Those 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 treated group lost at least 10% of their basis weight, while one third lost at least 20%. They also saw more substantial improvements in waist condition, blood pressure and self-reported quality of life.
On the face of it, the findings are nothing short of amazing, given the relative lack of options for people who want to tackle their obesity with medicines. (Several drugs are currently approved in the US for obesity, but none have demonstrated the level of success seen here.)
“The findings of this study represent a major breakthrough in improving the health of obese people,” said Rachel Batterham, an obesity researcher at University College London in the UK who helped lead part of the study, in a statement. pronunciation released by the university. “No other drug has reached this level of weight loss – this is truly a game changer. For the first time, people with drugs can achieve what was only possible through weight-loss surgery. “
Despite the promising news, at least some outside experts are more cautious about the implications of the study. In an accompanying editorial, Julie Ingelfinger and Clifford Rosen – both doctors and editors at NEJM – called the results a “good start.”
In the study, semaglutide was generally well tolerated, even at a higher dose, with symptoms such as nausea, diarrhea and vomiting that were 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, so 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 note that obesity is a chronic condition. And despite the length of the 68-week trial, we still don’t know how effective, safe, or practical it would be for someone to take a weekly injected 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 scientists should continue to evaluate whether the benefits outweigh the harms if it’s approved by regulatory agencies. Some health experts and activists have done that too questioned 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 optimal goal for some.
“In short, we still have a long way to go to get the obesity epidemic under control, but STEP 1 lives up to its name,” they wrote.
Regulatory health agencies such as the Food and Drug Administration will soon have to weigh these questions themselves, as Novo Nordisk already plans to submit the drug for approval as a treatment for obesity in Europe, the UK and the US.