For the first time, a drug has been shown to be so effective against obesity that patients can avoid many of its worst effects, including diabetes, researchers said Wednesday.
The drug, semaglutide, manufactured by Novo Nordisk, is already being marketed as a treatment for type 2 diabetes. In a clinical trial published in the New England Journal of Medicine, researchers at Northwestern University in Chicago tested semaglutide in a much higher dose than an anti-obesity medication.
Nearly 2,000 participants, at 129 centers in 16 countries, injected themselves weekly with semaglutide or a placebo for 68 weeks. Those who received the drug lost, on average, almost 15 percent of their body weight, compared with 2.4 percent among those who received the placebo.
More than a third of the participants who received the drug lost more than 20 percent of their weight. Symptoms of diabetes and pre-diabetes have improved in many patients.
The results far outweigh the weight loss observed in clinical trials with other obesity drugs, experts said. The drug is a ‘game changer’, says Dr. Robert F. Kushner, an obesity researcher at Northwestern University Feinberg School of Medicine, who led the study. “This is the beginning of a new era of effective treatments for obesity.”
Dr. Clifford Rosen of the Maine Medical Center Research Institute, who was not involved in the trial, said, “I think it has great potential for weight loss.” Gastrointestinal symptoms among the participants were ‘really marginal – nothing like in the past with drugs for weight loss’, said dr. Rosen, an editor of the New England Journal of Medicine and co-author of an editorial accompanying the study, added.
For decades, scientists have been searching for ways to help the growing number of people struggling with obesity. Five anti-obesity drugs currently available have side effects that limit their use. The most effective, phentermine, results in an average of 7.5 percent weight loss and can only be taken for a short time. After it is stopped, even the amount of weight is regained.
The most effective treatment to date is bariatric surgery, which helps people lose an average of 25 to 30 percent of their body weight, says Dr. Louis Aronne, a researcher on obesity at Weill Cornell Medicine in New York, who advises Novo Nordisk and studies semaglutide.
But surgery is an invasive solution that permanently changes the digestive system. Only 1 percent of those who qualify will go through the procedure. Instead, most obese people try dieting with disappointing results.
The semaglutide study confirms what scientists already know, dr. Kushner said: Willpower is not enough. In the new trial, participants who received the placebo and diet and exercise counseling could not see any significant difference in their weight.
In general, insurers have refused to pay for the weight loss drugs on the market. Semaglutide is likely to be expensive. The lower dose used to treat diabetes has an average selling price of almost $ 1,000 per month. (Insurers usually pay for diabetes medication, Dr. Kushner noted.)
Dr. Caroline Apovian, co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and a member of the Novo Nordisk advisory board, said the efficacy of semaglutide was “phenomenal” and that the test results could lead insurers it can cover. .
Semaglutide is a synthetic version of a natural hormone that acts on appetite in the brain and intestines and causes feelings of satiety. A high-dose regimen of the drug has not been studied long enough to know if it has serious long-term consequences.
And patients are expected to take it for life to prevent the weight loss from returning.
Qiana Mosely, who lives in Chicago, tried for years to lose weight with diets and drugs, but to no avail. Then Mrs. Mosely joined the semaglutide trial and lost about 15 percent of her weight.
Until recently, Mosely did not know if she was getting the drug or the placebo. Even though she tried to eat and exercise well, her weight “dropped too fast,” she said. “It had to be the medicine.”
She did not experience any side effects, she said. But when the trial ended and she no longer received the drug, the weight began to return. “I was so sad,” she said. She is eager to take the medicine again as soon as it is available.