Positive results from a post-hoc analysis of data from the phase 3a Satiety and Clinical Adiposity–Liraglutide Evidence (SCALE) maintenance trial were recently presented at the 24th European Congress on Obesity. In the trial, adults who lost at least 5% of their initial weight during a low-calorie run-in period were randomized to liraglutide 3 mg (Saxenda, Novo Nordisk) (n = 212) or placebo (n = 210). After 16 weeks of treatment with liraglutide, participants who lost an additional 5% or more of their body weight (defined as “early responders”) were more likely to maintain weight loss and achieve greater additional weight loss over 56 weeks, compared with people losing less than 5% body weight after 16 weeks of liraglutide treatment (“early nonresponders”).
“In the obesity specialist setting, low-calorie diets combined with increased physical activity are commonly used to induce an initial weight loss in people with obesity. However, when the initial weight loss reaches a plateau and patients enter the ‘weight maintenance phase’ with less stringent caloric restriction, we often see that many experience weight regain,” said Sean Wharton, MD, PharmD, medical director at the Wharton Medical Clinic in Ontario and SCALE clinical trial investigator. “As a consequence, pharmacotherapy can be used to help people with obesity in maintaining the weight loss that has already been achieved by a low-calorie diet and increased physical activity. These data are very encouraging to clinicians in this specialist setting, because they show that early responders to Saxenda are able to both maintain and achieve additional weight loss.”
Of those who completed 56 weeks of treatment with liraglutide, 68% were early responders at week 16 and 32% were early nonresponders. In addition to weight loss achieved during the run-in period, early responders experienced 9.9% weight loss, compared with 0% in early nonresponders at 56 weeks.
Following 56 weeks of treatment, 91.7% of early responders and 47.1% of early nonresponders had maintained or lost additional weight following the run-in period. No early responders regained their run-in weight loss over 56 weeks of treatment with liraglutide, compared with 3.9% of early nonresponders.
There were similar incidences of total adverse events in early responders (92.7%) and early nonresponders (91%). Gastrointestinal adverse events were more frequent in early responders compared with early nonresponders (78.9% versus 62.7%). Liraglutide was generally well tolerated, with observed side effects in line with previous trials.
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 appetite by increasing feelings of fullness and satiety, while lowering feelings of hunger and prospective food consumption, thereby leading to reduced food intake. As with other GLP-1 receptor agonists, liraglutide stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner.
Source: Novo Nordisk; May 17, 2017.