Empros Pharma (Sweden)

ABSTRACTObjectiveThis study aimed to evaluate the added effect of acarbose to orlistat on relative weight loss in the novel antiobesity medication EMP16.MethodsIn 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.ResultsMean 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.ConclusionsAcarbose enhances the weight loss efficacy of EMP16, supporting its potential as a safe and effective treatment for long‐term obesity management.Trial RegistrationEU Clinical Trials Register: EudraCT‐nr. 2022‐003320‐40

ObjectiveThe aim of this study was to evaluate the effect of a novel, oral, modified‐release formulation of the lipase inhibitor orlistat and the glucosidase/amylase inhibitor acarbose (denoted EMP16) on relative body weight after 26 weeks compared with placebo.MethodsThe randomized, double‐blind, placebo‐controlled trial had a 26‐week treatment period, with dose escalation up to 6 weeks. Participants, adults between ages 18 and 75 years, with BMI ≥30 kg/m2 or ≥28 kg/m2 with risk factors, were randomly assigned to EMP16 120‐mg orlistat/40‐mg acarbose (EMP16‐120/40), EMP16‐150/50, or placebo. The primary end point was relative weight loss from baseline to week 26 assessed in participants with at least one post‐baseline weight measurement.ResultsOf 156 randomized participants, 149 constituted the intention‐to‐treat population. The mean (95% CI) estimated treatment difference to placebo in relative weight loss after 26 weeks in the intention‐to‐treat population was −4.70% (−6.16% to −3.24%; p < 0.0001) with EMP16‐120/40 and −5.42% (−6.60% to −4.24%; p < 0.0001) with EMP16‐150/50.ConclusionsThis trial indicates that orlistat and acarbose can be successfully combined in a modified‐release formulation to provide efficacious weight loss with no unexpected safety issues. EMP16 may be a promising candidate among other medications for improved weight management.