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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Long-term efficacy and safety of lerodalcibep in heterozygous familial hypercholesterolaemia: the LIBerate-HeFH trial
European Heart Journal, Volume 44, No. 40, Year 2023
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Description
Background and Lerodalcibep, a novel small recombinant fusion protein of a proprotein convertase subtilisin/kexin type 9 gene–binding do-Aims main (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. Methods 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. Results In 478 randomized subjects [mean age (range); 53 (18–80) 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 −2.30 to −1.87] with a percentage difference of −58.61 (3.25)% at Week 24 and by 2.28 (0.10) mmol/L (95% confidence interval −2.47 to −2.09) with a percentage difference of −65.0 (2.87)% at the mean of Weeks 22 and 24 (P < .0001 for all). With lerodalcibep, 68% of subjects achieved both a reduction in LDL-C ≥ 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. Conclusions 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. © The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.
Authors & Co-Authors
Raal, Frederick Johan
South Africa, Johannesburg
University of the Witwatersrand
Blom, Dirk J.
South Africa, Cape Town
University of Cape Town
de Vries Basson, Matthys M.
South Africa, Bellville
Karl Bremer Hospital
Kayikçioǧlu, Meral
Turkey, Izmir
Ege Üniversitesi
Kallend, David G.
United States, Cincinnati
Lib Therapeutics
Stein, Evan A.
United States, Cincinnati
Lib Therapeutics
Statistics
Citations: 3
Authors: 6
Affiliations: 6
Identifiers
Doi:
10.1093/eurheartj/ehad596
ISSN:
0195668X
Research Areas
Genetics And Genomics
Participants Gender
Female