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Nine Out of 10 Obese Adults Lose Weight With Liraglutide in Phase III Trial
In new data presented at the 2nd Annual Congress of the American Society for Metabolic and Bariatric Surgery and the Obesity Society, 92% (9 out of 10) of participants in a phase IIIa clinical trial lost weight during treatment with liraglutide (Novo Nordisk), in combination with diet and exercise, compared with 65% of subjects receiving placebo.
Subjects that completed the 56-week study demonstrated significantly greater weight loss of 9.2% with liraglutide 3 mg compared with a 3.5% weight reduction in the placebo group (estimated difference: 5.7%; P < 0.0001).
In addition, weight loss with liraglutide was similar across a range of baseline body mass index (BMI) subgroups in subjects with obesity, from overweight to class III obesity, at 56 weeks (P = 0.054, %; P = 0.54, kg) and independent of prediabetes status at screening (–8.0% with vs. –7.9% without; P = 0.59). A larger proportion of subjects treated with liraglutide completed the trial compared with those receiving placebo (72% vs. 64%, respectively). All treatment groups followed a reduced-calorie diet and an increased physical activity program.
Weight loss associated with liraglutide 3 mg was accompanied by improvements in health-related quality of life, as measured by three questionnaires. Greater improvements were seen with liraglutide compared with placebo. The Impact of Weight on Quality of Life–Lite (IWQoL) total score improved mostly because of better physical functioning. Both the Short-Form Health Survey (SF-36) summaries of physical scores and mental health scores improved.
In addition, the total Treatment-Related Impact Measure–Weight (TRIM-W) score was better at 56 weeks with liraglutide compared with placebo.
Obesity is associated with serious co-morbidities, including type-2 diabetes, heart disease, obstructive sleep apnea, certain types of cancer, and a decreased life expectancy. The risk of morbidity and mortality increases with the severity of obesity.
The global increase in the prevalence of obesity is a public health issue that has severe cost implications to health care systems, according to the investigators. In the U.S., approximately 35% of U.S. adults –– equivalent to approximately 80 million adults –– are obese.
Liraglutide is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake. Like human GLP-1, liraglutide regulates the patient’s appetite and food intake by decreasing hunger and by increasing feelings of fullness and satiety after eating.
Liraglutide is an investigational product and is not approved by the FDA.
Source: Novo Nordisk; November 4, 2014.