{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T22:20:33Z","timestamp":1792794033639,"version":"4.5.0"},"reference-count":26,"publisher":"Oxford University Press (OUP)","issue":"40","license":[{"start":{"date-parts":[[2023,8,28]],"date-time":"2023-08-28T00:00:00Z","timestamp":1693180800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"LIB Therapeutics","id":[{"id":"https:\/\/ror.org\/05kyaaw03","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,10,21]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aims<\/jats:title>\n                    <jats:p>Lerodalcibep, a novel small recombinant fusion protein of a proprotein convertase subtilisin\/kexin type 9 gene\u2013binding domain (adnectin) and human serum albumin, demonstrated highly effective low-density lipoprotein cholesterol (LDL-C) reduction with monthly 300 mg in 1.2 mL subcutaneous dosing in Phase 2. In this global Phase 3 trial, the safety and efficacy of lerodalcibep were evaluated in heterozygous familial hypercholesterolaemia patients requiring additional LDL-C lowering.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients were randomized 2:1 to monthly subcutaneous injections of either lerodalcibep 300 mg or placebo for 24 weeks. The primary efficacy endpoints were the per cent change from baseline in LDL-C at Week 24 and the mean of Weeks 22 and 24.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In 478 randomized subjects [mean age (range); 53 (18\u201380) years, 51.7% female, mean (SD) baseline LDL-C 3.88 (1.66) mmol\/L], lerodalcibep reduced LDL-C, compared with placebo by an absolute amount of 2.08 (0.11) mmol\/L [LS mean (SE); 95% confidence interval \u22122.30 to \u22121.87] with a percentage difference of \u221258.61 (3.25)% at Week 24 and by 2.28 (0.10) mmol\/L (95% confidence interval \u22122.47 to \u22122.09) with a percentage difference of \u221265.0 (2.87)% at the mean of Weeks 22 and 24 (P &amp;lt; .0001 for all). With lerodalcibep, 68% of subjects achieved both a reduction in LDL-C \u2265 50% and the recommended European Society of Cardiology LDL-C targets during the study. Except for mild injection site reactions, treatment-emergent adverse events were similar between lerodalcibep and placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Lerodalcibep, a novel anti-proprotein convertase subtilisin\/kexin type 9 gene small binding protein dosed monthly as an alternative to monoclonal antibodies, significantly reduced LDL-C in subjects with heterozygous familial hypercholesterolaemia with a safety profile similar to placebo.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/eurheartj\/ehad596","type":"journal-article","created":{"date-parts":[[2023,8,28]],"date-time":"2023-08-28T13:41:04Z","timestamp":1693230064000},"page":"4272-4280","source":"Crossref","is-referenced-by-count":74,"title":["Long-term efficacy and safety of lerodalcibep in heterozygous familial hypercholesterolaemia: the LIBerate-HeFH 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