“The US Food and Drug Administration recently approved liraglutide 3.0 mg for the treatment of obesity as an adjunct to diet and exercise,” said lead study author Patrick M. O'Neil, PhD, director of the Weight Management Center and professor in the Department of Psychiatry and Behavioral Sciences of the Medical University of South Carolina in Charleston. “In the US, 3.0 mg of liraglutide is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults who are overweight or obese and have at least one weight-related comorbidity.”
The worldwide increase in the prevalence of obesity is a serious public health issue, with rates of obesity having nearly doubled since 1980. In the United States, roughly 80 million people – around 35% of adults – have obesity.
To examine the efficacy and safety of liraglutide for weight management, Dr. O’Neil and his colleagues conducted the double-blind, placebo-controlled multinational SCALE Obesity and Prediabetes trial over 56 weeks. They randomized 2,487 overweight or obese study participants to treatment with liraglutide 3.0 mg and 1,244 participants to placebo, in combination with diet and exercise. Their average age was 45 years and 79% were female. The participants had comorbidities, such as prediabetes, hypertension and dyslipidemia, but people with diabetes were excluded from the trial.
Participants who lost 5% or more of their body weight after 56 weeks were called “responders.”
After 56 weeks, 63.2% of participants on liraglutide were considered “responders,” compared with 27.1% of those on placebo, and responders in both the drug and placebo groups achieved clinically meaningful improvements. Fasting plasma glucose decreased most among the responders in the liraglutide group followed by the non-responders in the liraglutide group. Waist circumference, systolic blood pressure, and 36-Item Short Form Health Survey (SF-36) decreased most among the responders in the liraglutide group followed by the responders in the placebo group.
The rates of adverse events were largely similar in responders and non-responders.
“Many people with obesity are unaware of its severity and its implications for their health. Losing 5% to 10% of their weight can give them significant health benefits, including improvements in blood glucose levels, blood pressure, cholesterol levels and obstructive sleep apnea. The nature of this disease is complex and maintaining weight loss can be challenging. Multiple treatment options are needed to help people with obesity lose weight, keep it off, and improve their health,” Dr. O’Neil said.
Novo Nordisk funded this study.
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