The drug that could open a “new era” in anti-obesity drugs
Semaglutide, a Drug That May Help Regulate Appetite, Could Open “New Era” in Anti-Obesity Treatments After Multiple Large-Scale Clinical Trials Show Significant Weight Reduction in Obese Participants and overweight.
New anti-obesity drug will “change the game”, some experts say
Semaglutide, a medicine made by Novo Nordisk, mimics a hormone called glucagon-like peptide-1 to target areas of the brain that regulate appetite and food intake. The drug has previously been used as a treatment for type 2 diabetes.
To assess its potential use as an anti-obesity treatment, Novo Nordisk funded the Clinical Trial Program on the Treatment Effect of Semaglutide in Obese People (STEP). The STEP program included four Phase 3 clinical trials with more than 4,500 participants.
In the STEP 1 trial, which was published in the New England Journal of Medicine, researchers from Northwestern University recruited 1,961 adults at 129 centers in 16 countries. Participants who had weight problems, such as diabetes, had a BMI of at least 27. Participants without any problems had a BMI of at least 30.
Participants were randomly assigned in a 2: 1 ratio to a weekly injection of 2.4 mg of semaglutide or to a placebo for 68 weeks. All of the participants also received a lifestyle intervention to help them with their weight loss efforts.
At the end of the study, participants who received semaglutide lost an average of 14.9% of their body weight, compared to 2.4% in the placebo group. In addition, more than a third of participants lost at least 20% of their body weight, and many participants saw their symptoms of diabetes and prediabetes improve.
The four STEP clinical trials produced similar results, Medscape reports, with weight loss for participants receiving semaglutide averaging between 10% and 17%.
In comparison, many anti-obesity drugs currently available generally result in a 5-9% reduction in body weight. And although semaglutide is not as effective as bariatric surgery, which can lead to a 25-30% weight reduction, many patients may prefer the drug to invasive surgery.
According to Robert Kushner, an obesity researcher at Northwestern University Feinberg School of Medicine, who led the STEP 1 study, semaglutide is a âgame changerâ for obese people. “This is the start of a new era of effective treatment for obesity,” he added.
The future of anti-obesity drugs
In June, FDA has approved semaglutide as a treatment for chronic weight management in obese or overweight adults – the first drug approved for such use since 2014. Currently, there are six drugs approved by the FDA for the long-term treatment of obesity.
“[This] approval gives obese or overweight adults a beneficial new treatment option to integrate into a weight management program, âsaid John Sharretts, Deputy Director of the Diabetes, Lipid Disorders and Obesity Division at the FDA Center for Drug Evaluation and Research. “The FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults suffering from obesity or overweight.”
In addition, the UK Medicines and Health Products Regulatory Agency approved the drug in September, and European Medicines Agency Committee for Medicinal Products for Human Use followed suit in November.
Currently, researchers are evaluating combination therapies of semaglutide and other drugs to potentially improve reduction in total weight loss, Medscape reports. For example, a 20-week phase 1b study, which was published in The Lancet, found that participants receiving a combination of semaglutide and the amylin agonist, cagrilintide, lost 17% of their initial weight. In comparison, participants on semaglutide alone lost only 8% of their initial weight.
“There is hope that in combination with cagrilintide and possibly with several other agents that are still in the early stages of development, we will see average weight loss comparable to that seen with bariatric surgery,” Kushner said. .
Christos Mantzoros from Beth Israel Deaconess Medical Center described obesity as the “epidemic crisis of our time,” noting that the disease causes “serious co-morbidities such as diabetes, fatty liver disease and cardiovascular disease, and dramatically shortens the length and quality of life of an anybody “. According to the FDA, about 70% of American adults are obese or overweight. (Kolata, New York Times, 7/1; Anekwe, Harvard Health Publishing, 9/10; FDA Press release, 6/4; Busko, Medscape, 10/27; Tucker, Medscape, 11/16; Wilding et al., New England Journal of Medicine, 3/18; Busko, Medscape, 6/28)