Energy intake as a short-term biomarker for weight loss in adults with obesity receiving liraglutide: A randomized trial.

BACKGROUND AND OBJECTIVE: Obesity is a chronic disease associated with many serious comorbidities. Pharmacologic therapies are approved for the treatment of obesity; however, short-term biomarkers to predict weight loss are not well understood. This study aimed to determine the ability of single-meal energy intake (EI) to predict weight loss in participants with obesity treated with liraglutide. METHODS: In this randomized, double-blind, placebo-controlled study, participants received subcutaneous liraglutide (titrated to 3.0 mg/day) or placebo once daily, with inpatient assessments at baseline and weeks 3 and 6. The primary endpoint was change from baseline (CFB) in EI during consecutive ad libitum lunch meals at weeks 3 and 6. Secondary endpoints included CFB in 24- and 48-h EI, weight, appetite scores, and gastric emptying measures. RESULTS: Sixty-one participants were randomized ( = 32, liraglutide;  = 29, placebo). The least squares mean (LSM) difference (95% CI; -value) in CFB in EI during ad libitum lunch meals between the liraglutide and placebo groups was -236 (-322, -149;  < 0.0001) kcal at week 3 and -244 (-339, -148,  < 0.0001) kcal at week 6. The liraglutide group experienced significant weight loss at weeks 3 and 6, compared with placebo. Weight loss was significantly correlated with EI, but not with appetite score or gastric emptying. CONCLUSIONS: EI during a single meal is a robust clinical predictor of weight changes in participants with obesity. Future clinical trials can utilize EI at a single meal as a predictor of weight loss.