In the phase 3, double-blind, randomized SCALE–Obesity and Prediabetes trial [NCT01272219], significantly more obese and overweight adults without diabetes mellitus were weight loss responders when treated with liraglutide, 3 mg, rather than placebo. Weight loss responders also had improvements in glycemic control, cardiometabolic outcomes, and quality of life. The SCALE–Obesity and Prediabetes trial was a subanalysis of the SCALE study, a large phase 3 clinical program investigating the safety and efficacy of liraglutide, 3 mg, for weight management in people with and without diabetes.

Patrick O’Neil, PhD, Medical University of South Carolina, Charleston, South Carolina, USA, presented the results of the subanalysis. Overweight (body mass index [BMI] ≥ 27 kg/m² with ≥ 1 comorbidities) or obese (BMI ≥ 30 kg/m²) patients without diabetes mellitus were randomized to liraglutide, 3 mg (n = 2487), or placebo (n = 1244) as an adjunct to diet and exercise. Overall baseline characteristics included a mean age of 45 years, a body weight of 106 kg, and a BMI of 38 kg/m².

The analysis compared key efficacy and safety outcomes of responders (≥ 5% weight loss at week 56 from baseline) vs nonresponders (< 5% weight loss at week 56 from baseline). At week 56, significantly more individuals on liraglutide vs placebo were weight loss responders (63.2% vs 27.1%; P < .0001). Mean weight loss for responders vs nonresponders on liraglutide was −11.7% vs −1.7%. In the placebo group, the respective figures were −10.0% vs +0.1%. Liraglutide was also associated with a greater reduction in waist circumference in responders vs nonresponders (–11.0 vs −3.3 cm). Respective figures in the placebo group were −10.0 vs −1.7 cm.

Fasting plasma glucose was lower for responders in the liraglutide vs placebo group (–8.3 vs −2.8 mg/dL). For nonresponders, the figures were −5.0 vs +1.1 mg/dL. In liraglutide vs placebo responders, respective reductions in systolic blood pressure were −5.5 vs −3.4 mm Hg. Nonresponders in both groups had respective findings of −2.0 vs −0.8 mm Hg. Change in overall physical health scores on the SF-36 Health Survey Update questionnaire for liraglutide vs placebo responders was +4.3 vs +4.1; for nonresponders, the respective outcomes were +2.1 vs +1.3.

The most common adverse events (AEs) were gastrointestinal related. These were higher in liraglutide vs placebo responders (69.2% vs 44.4%, respectively) than in liraglutide and placebo nonresponders (67.2% vs 39.6%, respectively). Responders had lower rates of AEs leading to withdrawal (liraglutide, 4.5%; placebo, 0.9%). In nonresponders, the figures were 17% for liraglutide vs 4.8% for placebo.

Liraglutide responders had greater improvements than nonresponders across a range of efficacy outcomes. Overall, weight loss ≥ 5% was achieved in a higher proportion of patients on liraglutide, 3 mg, with a stronger effect among responders. The rates of AEs were largely equivalent in responders and nonresponders.

A mean weight loss of 11.7% was achieved by patients who were overweight or obese without diabetes and responded to liraglutide. The weight loss responders in both treatment groups also had improved glycemic, cardiometabolic, and health-related quality-of-life outcomes. The SCALE–Obesity and Prediabetes trial showed that liraglutide is a safe and effective weight loss option in the study population.