EFFECT OF WEIGHT LOSS ON PHYSICAL FUNCTION MEASURED BY THE 6-MINUTE WALKING DISTANCE TEST IN INDIVIDUALS WITH OBESITY

RESULTS FROM THE SCALE IBT TRIAL OF LIRAGLUTIDE 3.0 mg

Abstract

INTRODUCTION
The SCALE IBT trial (NCT02963935) was a 56-week, randomized, double-blind, US-based multicenter trial of liraglutide 3.0 mg vs placebo, with intensive behavior therapy (IBT) (i.e., reduced calorie intake, increased physical activity [max target: 250 min/week], and 23 counseling) in both arms. The secondary endpoint was the change in 6-minute walking distance (6MWD), a test for walking capacity measured by total distance walked along a 20-m marked walkway over 6 minutes.

METHODOLOGY
For the trial, individuals aged ≥18 y with a BMI ≥30 kg/m2 and without diabetes were randomized 1:1 to IBT plus liraglutide 3.0 mg or placebo.The change in body weight and 6MWD from baseline to week 56 was calculated using ANCOVA. Linear regression was used for the correlation analysis of the association between 6MWD and BMI. There were 282 randomized individuals in the full analysis set (47 y, 17% male, BMI 39 kg/m2 ).

RESULTS
At 56 weeks, mean weight loss was 7.5% with liraglutide 3.0 mg and 4.0% with placebo, estimated treatment difference (ETD[95% CI] 3.5% [1.6, 5.3]; p=0.0003). Improvement in 6MWD was 49.5 m vs. 46.4 m, from a mean baseline of 439 m (ETD [95% CI] 3.1 [-12.7, 18.9]; p=0.70). Linear regression of baseline 6MWD vs. baseline BMI showed that on average an individual with a BMI that was 1 kg/m2 lower compared to another individual was able to walk 4.9 m longer in 6 minutes (slope [95% CI] -4.9 m/(kg/m2 ) [-6.2, -3.6]; p<0.0001).

CONCLUSION
This post-hoc analysis showed that greater weight loss was associated with greater improvements in 6MWD in a linear manner, indicating gains in walking capacity.