Holmbäck Ulf, Grudén Stefan, Kuusk Sandra, Litorp Helena, Englund Joakim, Söderhäll Arvid, Alderborn Göran, Forslund Anders
Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.
Empros Pharma AB, Solna, Sweden.
Obesity (Silver Spring). 2025 Oct;33(10):1855-1864. doi: 10.1002/oby.24369. Epub 2025 Aug 6.
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.
本研究旨在评估阿卡波糖联合奥利司他对新型抗肥胖药物EMP16相对体重减轻的附加作用。
在这项为期6个月的双盲试验中，240名患有肥胖或超重及合并症的个体被平均随机分为三组：（1）EMP16组（120毫克缓释奥利司他/40毫克缓释阿卡波糖），（2）MR - O组（120毫克缓释奥利司他），（3）Conv - O组（120毫克常规奥利司他）。主要结局指标是6个月后的相对体重减轻和分类体重减轻。
EMP16组的平均相对体重减轻为-7.73%，而MR - O组为-5.78%，Conv - O组为-5.13%（p < 0.01）。EMP16组体重减轻≥5%或≥10%的比例分别为61%/32%，而MR - O组为51%/20%，Conv - O组为48%/12%（体重减轻≥10%时p > 0.05）。所有组的血糖和血脂指标均有小幅改善，与Conv - O组相比，EMP16组在脂肪肝指数和生活质量方面有更大改善（p < 0.01）。未发生严重不良事件；大多数不良事件为轻度且短暂性。
阿卡波糖增强了EMP16的减肥效果，支持其作为长期肥胖管理的安全有效治疗方法的潜力。
欧盟临床试验注册：EudraCT编号2022 - 003320 - 40 。
