dc.creator | Romero Gómez, Manuel | es |
dc.creator | Lawitz, Eric | es |
dc.creator | Shankar, R. Ravi | es |
dc.creator | Chaudhri, Eirum | es |
dc.creator | Liu, Jie | es |
dc.creator | Lam, Raymond L.H. | es |
dc.creator | Kaufman, Keith D. | es |
dc.creator | Engel, Samuel S. | es |
dc.date.accessioned | 2024-04-25T13:27:11Z | |
dc.date.available | 2024-04-25T13:27:11Z | |
dc.date.issued | 2023 | |
dc.identifier.citation | Romero Gómez, M., Lawitz, E., Shankar, R.R., Chaudhri, E., Liu, J., Lam, R.L.H.,...,Engel, S.S. (2023). A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease. Journal of Hepatology, 79 (4), 888-897. https://doi.org/10.1016/j.jhep.2023.05.013. | |
dc.identifier.issn | 0168-8278 | es |
dc.identifier.uri | https://hdl.handle.net/11441/157159 | |
dc.description.abstract | 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 nonalcoholic 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 gastrointestinal
adverse events.
Conclusions: In patients with NAFLD, treatment with efinopegdutide 10 mg weekly led to a significantly greater reduction in LFC
than semaglutide 1 mg weekly. | es |
dc.format | application/pdf | es |
dc.format.extent | 11 p. | es |
dc.language.iso | eng | es |
dc.publisher | Elsevier | es |
dc.relation.ispartof | Journal of Hepatology, 79 (4), 888-897. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.title | A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease | es |
dc.type | info:eu-repo/semantics/article | es |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.relation.publisherversion | https://www.sciencedirect.com/science/article/pii/S0168827823003422?via%3Dihub | es |
dc.identifier.doi | 10.1016/j.jhep.2023.05.013 | es |
dc.journaltitle | Journal of Hepatology | es |
dc.publication.volumen | 79 | es |
dc.publication.issue | 4 | es |
dc.publication.initialPage | 888 | es |
dc.publication.endPage | 897 | es |