دورية أكاديمية
A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease
| العنوان: | A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease |
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| المؤلفون: | Romero-Gómez, Manuel, Lawitz, Eric, Shankar, R. Ravi, Chaudhri, Eirum, Liu, Jie, Lam, Raymond L. H., Kaufman, Keith D., Engel, Samuel S., for the MK-6024 P001 Study Group |
| المساهمون: | Merck Sharp & Dohme |
| بيانات النشر: | Elsevier European Association for the Study of the Liver |
| سنة النشر: | 2023 |
| المجموعة: | Digital.CSIC (Consejo Superior de Investigaciones Científicas / Spanish National Research Council) |
| مصطلحات موضوعية: | Efinopegdutide, Semaglutide, Nonalcoholic fatty liver disease, Liver fat content |
| الوصف: | © 2023 Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and The Author(s). Published by Elsevier B.V on Behalf of European Association for the Study of the Liver (EASL) This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0Test/). ; [Background & Aims] This study assessed the effects of the glucagon-like peptide-1 (GLP-1)/glucagon receptor co-agonist efinopegdutide relative to the selective GLP-1 receptor agonist semaglutide on liver fat content (LFC) in patients with non-alcoholic fatty liver disease (NAFLD). ; [Methods] This was a phase IIa, randomized, active-comparator-controlled, parallel-group, open-label study. A magnetic resonance imaging-estimated proton density fat fraction assessment was performed to determine LFC at screening and Week 24. Participants with an LFC of ≥10% at screening were randomized 1:1 to efinopegdutide 10 mg or semaglutide 1 mg, both administered subcutaneously once weekly for 24 weeks. Participants were stratified according to the concurrent diagnosis of type 2 diabetes mellitus (T2DM). Both drugs were titrated to the target dose over an 8-week time period. The primary efficacy endpoint was relative reduction from baseline in LFC (%) after 24 weeks of treatment. ; [Results] Among 145 randomized participants (efinopegdutide n = 72, semaglutide n = 73), 33.1% had T2DM. At baseline, mean BMI was 34.3 kg/m2 and mean LFC was 20.3%. The least squares (LS) mean relative reduction from baseline in LFC at Week 24 was significantly (p <0.001) greater with efinopegdutide (72.7% [90% CI 66.8–78.7]) than with semaglutide (42.3% [90% CI 36.5–48.1]). Both treatment groups had an LS mean percent reduction from baseline in body weight at Week 24 (efinopegdutide 8.5% vs. semaglutide 7.1%; p = 0.085). Slightly higher incidences of adverse events and drug-related adverse events were observed in the efinopegdutide group compared with the semaglutide group, primarily related to an imbalance in ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 0168-8278 1600-0641 |
| العلاقة: | Publisher's version; https://doi.org/10.1016/j.jhep.2023.05.013Test; Sí; Journal of Hepatology 79(4): 888-897 (2023); http://hdl.handle.net/10261/349752Test |
| DOI: | 10.1016/j.jhep.2023.05.013 |
| الإتاحة: | https://doi.org/10.1016/j.jhep.2023.05.013Test http://hdl.handle.net/10261/349752Test |
| حقوق: | open |
| رقم الانضمام: | edsbas.4B52A4D6 |
| قاعدة البيانات: | BASE |
| تدمد: | 01688278 16000641 |
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| DOI: | 10.1016/j.jhep.2023.05.013 |