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, LH Lam, Raymond, Skrypnyk, Igor, Bassan, Isaac, Скрипник, Ігор Миколайович |
| بيانات النشر: | Elsevier |
| سنة النشر: | 2023 |
| المجموعة: | eaUMSA electronic archive – repository of the UMSA / eaUMSA електронний архів – репозитарій ВДНЗУ «УМСА» (УКРАЇНСЬКА МЕДИЧНА СТОМАТОЛОГІЧНА АКАДЕМІЯ) |
| مصطلحات موضوعية: | Non-alcoholic fatty liver disease, steatosis, hepatic lipogenesis |
| الوصف: | 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 gastrointestinal adverse events. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease / M. Romero-Gómez, E. Lawitz, I. Skrypnyk [et al.] // Journal of Hepatology. – 2023. – Vol. 78. – P. 1–10.; http://repository.pdmu.edu.ua/handle/123456789/21443Test; https://doi.org/10.1016/j.jhep.2023.05.013Test |
| DOI: | 10.1016/j.jhep.2023.05.013 |
| الإتاحة: | https://doi.org/10.1016/j.jhep.2023.05.013Test http://repository.pdmu.edu.ua/handle/123456789/21443Test |
| رقم الانضمام: | edsbas.28AA1510 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/j.jhep.2023.05.013 |
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