New three-year data on Saxenda (liraglutide [rDNA origin] injection, Novo Nordisk), a glucagon-like peptide-1 (GLP-1) receptor agonist, have been presented at the Endocrine Society’s 98th Annual Meeting and Exposition, held in Boston, Massachusetts. The phase 3a SCALE (Satiety and Clinical Adiposity––Liraglutide Evidence) study involved obese adults without diabetes and overweight adults without diabetes who had weight-related comorbidities. After 160 weeks of treatment, subjects given Saxenda (n = 1,505) in combination with a reduced-calorie diet and increased physical activity showed significant improvements in cardiometabolic risk factors, such as blood pressure and cholesterol, compared with those receiving placebo (i.e., a reduced-calorie diet and increased physical activity alone; n = 749).
Saxenda was approved in 2014 as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition, such as hypertension, type-2 diabetes mellitus, or dyslipidemia.
The SCALE trial was a randomized, double-blind, placebo-controlled, multinational study in obese adults without diabetes and in adults without diabetes who were overweight with weight-related comorbidities. The study’s objectives were to demonstrate the safety and efficacy of Saxenda compared with placebo, as well as to investigate the ability of long-term Saxenda to delay the onset of type-2 diabetes in participants with prediabetes at baseline.
At week 160, subjects treated with Saxenda had lost more weight than had those treated with placebo (–6.1% vs. –1.9%, respectively; estimated treatment difference [ETD], –4.3%; P < 0.0001). In addition, treatment with Saxenda achieved results beyond weight loss, including improvements in some cardiometabolic risk factors, such as blood pressure and cholesterol. At week 160, participants randomly assigned to treatment with Saxenda experienced a greater reduction in systolic blood pressure compared with those given placebo (ETD, –2.8 mm Hg; P < 0.0001). Subjects treated with Saxenda also experienced greater improvements in triglyceride (ETD, –6%; P = 0.0003) and total cholesterol levels (ETD, –2%; P = 0.03) compared with placebo. In addition, subjects treated with Saxenda showed a greater reduction in mean waist circumference (ETD,–1.4 inches).
The three-year part of the SCALE trial also met its primary endpoint, demonstrating that continued treatment over three years with Saxenda, in combination with a reduced-calorie diet and increased physical activity, delayed the onset of type-2 diabetes compared with placebo.
After 160 weeks of treatment, the rate of serious adverse events was greater among subjects treated with Saxenda than among those receiving placebo (15.1% vs. 12.9%, respectively). The rates of gallbladder-related adverse events and confirmed acute pancreatitis were also higher among Saxenda-treated subjects (2.9 events per 100 patient-years of observation [PYO] and 0.29/100 PYO, respectively) compared with placebo-treated subjects (1.2/100 PYO and 0.13/100 PYO, respectively). The frequency of major adverse cardiovascular events was comparable between the Saxenda and placebo groups (0.19 vs. 0.20 events/100 PYO).
Saxenda is not indicated for the treatment of type-2 diabetes. It should not be used in combination with any other GLP-1 receptor agonist or with insulin. The effects of Saxenda on cardiovascular morbidity and mortality have not been established, nor have studies established the safety and efficacy of coadministration with other products for weight loss. Saxenda has not been studied in patients with a history of pancreatitis.
Source: Novo Nordisk; April 4, 2016.
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