The Supportive Effect of Acarbose to Orlistat in Weight Management—A Randomized, Double‐Blind, Multiarm Phase 2 Trial
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| Format: | Artículo Open Access |
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Wiley
2025
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| _version_ | 1867015026149163008 |
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| author | Ulf Holmbäck Stefan Grudén Sandra Kuusk Helena Litorp Joakim Englund Arvid Söderhäll Göran Alderborn Anders Forslund |
| author_facet | Ulf Holmbäck Stefan Grudén Sandra Kuusk Helena Litorp Joakim Englund Arvid Söderhäll Göran Alderborn Anders Forslund Ulf Holmbäck Stefan Grudén Sandra Kuusk Helena Litorp Joakim Englund Arvid Söderhäll Göran Alderborn Anders Forslund |
| collection | Wiley Open Access |
| contents | The Supportive Effect of Acarbose to Orlistat in Weight Management—A Randomized, Double‐Blind, Multiarm Phase 2 Trial Ulf Holmbäck Stefan Grudén Sandra Kuusk Helena Litorp Joakim Englund Arvid Söderhäll Göran Alderborn Anders Forslund Obesity 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 10.1002/oby.24369 http://creativecommons.org/licenses/by/4.0/ |
| doi_str_mv | 10.1002/oby.24369 |
| format | Artículo Open Access |
| id | wiley_oa_10_1002_oby_24369 |
| institution | Wiley Open Access |
| license_str_mv | http://creativecommons.org/licenses/by/4.0/ |
| publishDate | 2025 |
| publisher | Wiley |
| record_format | wiley_oa |
| spellingShingle | The Supportive Effect of Acarbose to Orlistat in Weight Management—A Randomized, Double‐Blind, Multiarm Phase 2 Trial Ulf Holmbäck Stefan Grudén Sandra Kuusk Helena Litorp Joakim Englund Arvid Söderhäll Göran Alderborn Anders Forslund Obesity The Supportive Effect of Acarbose to Orlistat in Weight Management—A Randomized, Double‐Blind, Multiarm Phase 2 Trial Ulf Holmbäck Stefan Grudén Sandra Kuusk Helena Litorp Joakim Englund Arvid Söderhäll Göran Alderborn Anders Forslund Obesity 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 10.1002/oby.24369 http://creativecommons.org/licenses/by/4.0/ |
| title | The Supportive Effect of Acarbose to Orlistat in Weight Management—A Randomized, Double‐Blind, Multiarm Phase 2 Trial |
| topic | Obesity |
| url | https://onlinelibrary.wiley.com/doi/10.1002/oby.24369 |