EARLY RESPONDERS TO LIRAGLUTIDE 3.0 mg AS ADJUNCT TO DIET+EXERCISE FROM THE SCALE MAINTENANCE TRIAL

Abstract

INTRODUCTION
The SCALE Maintenance trial randomized adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) + comorbidities who lost ≥5% of initial body weight (BW) during a 4–12-week low calorie diet (1200–1400 kcal/ day) run-in period (mean weight loss [WL]: 6.0%) prior to randomization to liraglutide 3.0 mg or placebo as an adjunct to diet and exercise.

METHODOLOGY
This post-hoc analysis of SCALE Maintenance compared outcomes in liraglutide 3.0 mg early responders vs. early non-responders (definition: ERs vs. ENRs; ≥4% vs. <4% WL at week 16 post-randomization). Efficacy outcomes are observed means or proportions for those completing 56 weeks’ treatment. The safety analysis set is used for adverse events (AEs).

RESULTS AND DISCUSSION
Mean characteristics at randomization (n=212) for liraglutide 3.0 mg were: 46 years old, 84% female, BMI 36 kg/m². Of those completing 56 weeks’ treatment, (n=159); 118 (74.2%) were ERs to liraglutide 3.0 mg and 41 (25.8%) ENRs. At week 56, mean WL was -9.2% in ERs vs. +0.3% in ENRs in addition to run-in WL. 89.8% of ERs maintained run-in weight loss (or lost further weight) during 56 weeks vs. 41.5% of ENRs. The percentage of those who regained all run-in WL by week 56 was 0.0% for ERs vs. 4.9% for ENRs. Percent achieving ≥5%, >10% or >15% WL at week 56 was 66.9%, 43.2% and 18.6% for ERs vs. 14.6%, 0.0%, and 0.0% for ENRs. ERs had greater change in mean waist circumference: -7.3 cm vs. +0.3 cm in ENRs. Changes in systolic/diastolic blood pressure were -0.2/+1.9 mmHg in ERs vs. -0.3/+1.6 mmHg in ENRs. Changes in HbA1c in ERs and ENRs were: -0.2% and -0.1% and fasting plasma glucose: -0.5 and -0.6 mmol/L. ERs with AEs was 91.2% vs. 94.3% for ENRs. Serious AEs were 4.4% vs. 0.0% and gastrointestinal AEs 78.1% vs. 60.4% for ERs vs. ENRs, respectively.

CONCLUSION
Among those who completed 56 weeks’ treatment on liraglutide 3.0 mg, a greater additional WL of -9.2% was observed for ERs vs. +0.3% for ENRs, with a similar proportion experiencing AEs.