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

IF 4.7 2区医学 Q1 ENDOCRINOLOGY & METABOLISM

Obesity Pub Date : 2025-08-06 DOI:10.1002/oby.24369

Ulf Holmbäck, Stefan Grudén, Sandra Kuusk, Helena Litorp, Joakim Englund, Arvid Söderhäll, Göran Alderborn, Anders Forslund

{"title":"The Supportive Effect of Acarbose to Orlistat in Weight Management—A Randomized, Double-Blind, Multiarm Phase 2 Trial","authors":"Ulf Holmbäck, Stefan Grudén, Sandra Kuusk, Helena Litorp, Joakim Englund, Arvid Söderhäll, Göran Alderborn, Anders Forslund","doi":"10.1002/oby.24369","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Objective</h3>\n \n <p>This study aimed to evaluate the added effect of acarbose to orlistat on relative weight loss in the novel antiobesity medication EMP16.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>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 (<i>p</i> < 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 (<i>p</i> > 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 (<i>p</i> < 0.01). No serious adverse events occurred; most AEs were mild and transient.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Acarbose enhances the weight loss efficacy of EMP16, supporting its potential as a safe and effective treatment for long-term obesity management.</p>\n </section>\n \n <section>\n \n <h3> Trial Registration</h3>\n \n <p>EU Clinical Trials Register: EudraCT-nr. 2022-003320-40</p>\n </section>\n </div>","PeriodicalId":215,"journal":{"name":"Obesity","volume":"33 10","pages":"1855-1864"},"PeriodicalIF":4.7000,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/oby.24369","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Obesity","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/oby.24369","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}

引用次数: 0

Abstract

Objective

This study aimed to evaluate the added effect of acarbose to orlistat on relative weight loss in the novel antiobesity medication EMP16.

Methods

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.

Results

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.

Conclusions

Acarbose enhances the weight loss efficacy of EMP16, supporting its potential as a safe and effective treatment for long-term obesity management.

Trial Registration

EU Clinical Trials Register: EudraCT-nr. 2022-003320-40

Abstract Image

查看原文本刊更多论文

阿卡波糖对奥利司他体重控制的支持作用——一项随机、双盲、多组2期试验。

目的：本研究旨在评价阿卡波糖在新型抗肥胖药物EMP16中对奥利司他的增重作用。方法：在这项为期6个月的双盲试验中，240名肥胖或超重且有合并症的患者被随机分为三组：(1)EMP16（奥利司他改良释放120 mg /阿卡波糖改良释放40 mg）， (2) MR-O（奥利司他改良释放120 mg）， (3) convo（常规奥利司他120 mg）。主要结果是6个月后的相对和分类体重减轻。结果：EMP16组的平均相对体重减轻率为-7.73%，MR-O组为-5.78%，con - o组为-5.13% （p < 0.05,≥10%）。所有组的血糖和脂质指标均有小幅改善，与con - o相比，EMP16在脂肪肝指数和生活质量方面表现出更大的改善(p)。结论：阿卡波糖增强了EMP16的减肥功效，支持其作为一种安全有效的长期肥胖治疗方法的潜力。试验注册：EU临床试验注册：eudrac -nr。2022-003320-40。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Obesity 医学-内分泌学与代谢

CiteScore

11.70

自引率

1.40%

发文量

261

审稿时长

2-4 weeks

期刊介绍： Obesity is the official journal of The Obesity Society and is the premier source of information for increasing knowledge, fostering translational research from basic to population science, and promoting better treatment for people with obesity. Obesity publishes important peer-reviewed research and cutting-edge reviews, commentaries, and public health and medical developments.