Liraglutide for Weight Management

Study Questions:

Does liraglutide in addition to lifestyle counseling promote weight loss?

Methods:

The SCALE Obesity and Prediabetes Study was a double-blind, randomized, controlled trial, which included 3,731 patients who did not have type 2 diabetes and a body mass index (BMI) of ≥30 kg/m2, or a BMI of ≥27 kg/m2 with a diagnosis of dyslipidemia or hypertension. Participants were randomly assigned in a 2:1 ratio to subcutaneous injections (once daily) of liraglutide (doses of 3.0 mg) or placebo. Both groups received lifestyle counseling. After 56 weeks, participants in the liraglutide group (without prediabetes) were further randomized to continued liraglutide or changed to placebo for 12 weeks to address efficacy after discontinuing liraglutide. The primary endpoints included change in body weight and the proportion of patients losing at least 5% and 10% or greater of their initial body weight. Additional outcomes included change in cardiometabolic factors. Safety outcomes were also assessed.

Results:

A total of 2,487 participants were randomized to liraglutide and 1,244 participants were assigned to placebo. Approximately 72% of participants in the liraglutide group and 64% in the placebo group completed 56 weeks of the trial. More participants in the liraglutide group reported adverse events (9.9%) compared to those in the placebo group (3.8%). At baseline, mean age of participants was 45 years, mean weight was 106.2 kg, and mean BMI was 38.6 kg/m2. More participants were female (78.5%), and 61.2% had prediabetes. By 56 weeks, participants in the liraglutide group lost a mean 8.4 ± 7.3 kg of body weight compared to mean weight loss of 2.8 ± 6.5 kg in the control group (a difference of −5.6 kg; 95% confidence interval, −6.0 to −5.1; p < 0.001). More participants in the liraglutide group lost ≥5% of their body weight compared to the placebo group (63.2% vs. 27.1%, p < 0.001). Those in the liraglutide group also lost >10% of their body weight compared to the placebo group (31.1% vs. 10.6%, p < 0.001). Reported adverse events in the liraglutide group included mild to moderate nausea and diarrhea. Serious events occurred in 6.2% of the liraglutide group and 5.0% of the placebo group. Liraglutide was associated with improvement in cardiometabolic risk factors including waist circumference, blood pressure, and markers of inflammation.

Conclusions:

The investigators concluded that 3.0 mg of liraglutide once daily in addition to lifestyle modification was associated with reduced body weight and improved metabolic parameters compared with placebo.

Perspective:

This study suggests that liraglutide is effective in conjunction with lifestyle modification for weight loss. Further study on the long-term effects of liraglutide, including duration of time patients can maintain weight loss, is warranted.

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Hypertension

Keywords: Blood Pressure, Body Mass Index, Body Weight, Counseling, Diabetes Mellitus, Type 2, Double-Blind Method, Dyslipidemias, Glucagon-Like Peptide 1, Hypertension, Inflammation, Injections, Subcutaneous, Life Style, Metabolic Syndrome X, Obesity, Prediabetic State, Primary Prevention, Risk Factors, Waist Circumference, Weight Loss


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