The Supportive Effect of Acarbose to Orlistat in Weight Management-A Randomized, Double-Blind, Multiarm Phase 2 Trial.

Abstract

This study aimed to evaluate the added effect of acarbose to orlistat on relative weight loss in the novel antiobesity medication EMP16. In this 6-month double-blind trial, 240 individuals with obesity or overweight and comorbidities were randomized equally into three groups: (1) EMP16 (120 mg modified release orlistat/40 mg modified release acarbose), (2) MR-O (120 mg modified release orlistat), and (3) Conv-O (120 mg conventional orlistat). The primary outcomes were relative and categorical weight loss after 6 months. Mean relative weight loss was -7.73% for the EMP16 group as compared to -5.78% for the MR-O group and -5.13% for the Conv-O group (p < 0.01). Proportion achieving ≥ 5% or ≥ 10% weight reduction was 61%/32% in EMP16 group, compared to 51%/20% in the MR-O and 48%/12% in the Conv-O group (p > 0.05 for ≥ 10%). All groups showed small improvements in glucose and lipid markers, with EMP16 demonstrating greater improvement in fatty liver index and quality of life compared to Conv-O (p < 0.01). No serious adverse events occurred; most AEs were mild and transient. Acarbose enhances the weight loss efficacy of EMP16, supporting its potential as a safe and effective treatment for long-term obesity management. EU Clinical Trials Register: EudraCT-nr. 2022-003320-40.