The FDA granted approval for for the treatment of chronic weight management, combined with a reduced-calorie diet and physical activity, in December 2014.
The drug is designed for adults with obesity (body mass index (BMI) >30) or overweight (BMI >27) and also affected with one obesity-related condition such as type 2 diabetes, cardiovascular disease, hypertension or high cholesterol.
In April 2020, a supplemental indication for the drug received approval from the FDA for chronic weight management in obese patients aged 12 years and older.
In March 2021, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use recommended the use of the drug for treating obesity in adolescents aged 12-17 years.
Obesity and its prevalence
Obesity is a weight-related disorder that affects more than a third of adults in the US. The condition can be measured using BMI, the measurement of body fat based on the person's height and weight.
Obesity can lead to several health issues, including heart disease, type 2 diabetes and certain cancers, and results in a decreased life expectancy.
It is estimated that 80 million adults in the US suffer from obesity.
mechanism of action
contains an active component called liraglutide, which is a glucagon-like peptide-1 (GLP-1) analogue. The drug, which can be administered intravenously, reaches activated neurons in brain regions and regulates the appetite and calorie intake.
contains an active component called liraglutide, which is a glucagon-like peptide-1 (GLP-1) analogue. The drug reaches activated neurons in brain regions, and regulates appetite and calorie intake."
Clinical trials on
The FDA's approval of was based on results from three Phase III clinical trials, known as SCALE (Satiety and Clinical Adiposity−Liraglutide Evidence in Nondiabetic and Diabetic people) studies, which were conducted for 56 weeks to evaluate the drug's safety and efficacy.
More than 5,000 participants were enrolled in the three SCALE clinical trials, each of whom was obese or overweight and with or without other weight-related conditions.
The first SCALE clinical trial was a randomised, double-blind, placebo-controlled study. It enrolled 3,731 patients with obesity. The second study enrolled 635 patients with type 2 diabetes who were either overweight or obese, while the third study enrolled 422 patients with obesity.
Patients were given 3mg of daily or a placebo for 56 weeks and received counselling about lifestyle changes they needed to adopt related to a low-calorie diet and regular physical exercise.
The primary efficacy parameters of the first and second SCALE clinical studies included the mean percentage change in body weight and the percentages of patients achieving greater than or equal to 5% and 10% weight loss from baseline to week 56.
The third study's primary efficacy parameters included the percentage change in body weight from randomisation, the percentage of patients not gaining more than 0.5% body weight from randomisation, and the percentage of patients achieving greater than or equal to 5% weight loss from randomisation to week 56.
Results from the studies demonstrated that patients treated with experienced a statistically significant reduction in weight, compared with a placebo after 56 weeks. Patients treated with achieved a 5% and 10% weight loss compared to a placebo.
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